Trial Outcomes & Findings for Lenalidomide and Dexamethasone With or Without Thalidomide in Treating Patients With Multiple Myeloma (NCT NCT00098475)
NCT ID: NCT00098475
Last Updated: 2025-11-28
Results Overview
Objective response is defined as either complete response (CR) or partial response (PR). Patients who have complete disappearance of an M-protein and no evidence of myeloma in the bone marrow are considered to have CR. PR requires all the following: (1) ≥50% reduction in the level of the serum monoclonal paraprotein. (2) Reduction in 24-hour urinary light chain excretion either by ≥90% or to \<200 mg. (3)For patients with non-secretory (or oligosecretory) myeloma only, a ≥50% reduction in plasma cells in a bone marrow aspirate and on trephine biopsy must be documented. (4)50% reduction in size of soft tissue plasmacytoma (by radiography or clinical examination). (5) No increase in the number or size of lytic bone lesions (development of a compression fracture does not exclude response). As the expansion phase was a substudy terminated early with only 7 patients enrolled, the clinical results presented are mainly for the first phase only.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
452 participants
Primary outcome timeframe
Assessed every 4 weeks for 16 weeks during Step 1
Results posted on
2025-11-28
Participant Flow
The study opened on October 26, 2004 and was closed on June 1, 2007 with a total accrual of 452 patients enrolled from 6 groups and 77 institutions.
Participant milestones
| Measure |
Arm I (Lenalidomide, Dexamethasone)
Patients receive oral lenalidomide once daily on days 1-21, oral aspirin (or other deep vein thrombosis prophylaxis at the discretion of the principal investigator) once daily on days 1-28, and standard-dose oral dexamethasone once daily on days 1-4, 9-12, and 17-20. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and high-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1-4, 9-12, and 17-20 for 4 cycles.
|
Arm II (Lenalidomide, Low-dose Dexamethasone)
Patients receive oral lenalidomide and acetylsalicylic acid as in arm I and low-dose oral dexamethasone once daily on days 1, 8, 15, and 22. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and low-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1, 8, 15, and 22 for 4 cycles.
|
Arm III (Expansion; Lenalidomide, Dexamethasone, Aspirin)
Patients receive oral lenalidomide once daily on days 1-21, oral aspirin (or other deep vein thrombosis prophylaxis at the discretion of the principal investigator) once daily on days 1-28, and standard-dose oral dexamethasone once daily on days 1-4, 9-12, and 17-20. After 4 cycles of treatment, patients may discontinue treatment or continue until progression.
|
Arm IV (Expansion; Lenalidomide, Dexamethasone, Coumadin)
Patients receive oral lenalidomide once daily on days 1-21, oral aspirin (or other deep vein thrombosis prophylaxis at the discretion of the principal investigator) once daily on days 1-28, and standard-dose oral dexamethasone once daily on days 1-4, 9-12, and 17-20. After 4 cycles of treatment, patients may discontinue treatment. For patients continuing therapy beyond 4 cycles, coumadin was discontinued and aspirin was given instead.
|
|---|---|---|---|---|
|
Step 1
STARTED
|
223
|
222
|
4
|
3
|
|
Step 1
Treated
|
223
|
220
|
4
|
3
|
|
Step 1
Eligible
|
214
|
208
|
4
|
3
|
|
Step 1
COMPLETED
|
52
|
49
|
0
|
0
|
|
Step 1
NOT COMPLETED
|
171
|
173
|
4
|
3
|
|
Step 2
STARTED
|
5
|
15
|
0
|
0
|
|
Step 2
Treated
|
4
|
14
|
0
|
0
|
|
Step 2
Eligible
|
2
|
9
|
0
|
0
|
|
Step 2
COMPLETED
|
0
|
5
|
0
|
0
|
|
Step 2
NOT COMPLETED
|
5
|
10
|
0
|
0
|
Reasons for withdrawal
| Measure |
Arm I (Lenalidomide, Dexamethasone)
Patients receive oral lenalidomide once daily on days 1-21, oral aspirin (or other deep vein thrombosis prophylaxis at the discretion of the principal investigator) once daily on days 1-28, and standard-dose oral dexamethasone once daily on days 1-4, 9-12, and 17-20. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and high-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1-4, 9-12, and 17-20 for 4 cycles.
|
Arm II (Lenalidomide, Low-dose Dexamethasone)
Patients receive oral lenalidomide and acetylsalicylic acid as in arm I and low-dose oral dexamethasone once daily on days 1, 8, 15, and 22. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and low-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1, 8, 15, and 22 for 4 cycles.
|
Arm III (Expansion; Lenalidomide, Dexamethasone, Aspirin)
Patients receive oral lenalidomide once daily on days 1-21, oral aspirin (or other deep vein thrombosis prophylaxis at the discretion of the principal investigator) once daily on days 1-28, and standard-dose oral dexamethasone once daily on days 1-4, 9-12, and 17-20. After 4 cycles of treatment, patients may discontinue treatment or continue until progression.
|
Arm IV (Expansion; Lenalidomide, Dexamethasone, Coumadin)
Patients receive oral lenalidomide once daily on days 1-21, oral aspirin (or other deep vein thrombosis prophylaxis at the discretion of the principal investigator) once daily on days 1-28, and standard-dose oral dexamethasone once daily on days 1-4, 9-12, and 17-20. After 4 cycles of treatment, patients may discontinue treatment. For patients continuing therapy beyond 4 cycles, coumadin was discontinued and aspirin was given instead.
|
|---|---|---|---|---|
|
Step 1
Progressive disease
|
33
|
35
|
2
|
1
|
|
Step 1
Adverse Event
|
56
|
37
|
0
|
1
|
|
Step 1
Death
|
8
|
5
|
0
|
1
|
|
Step 1
Withdrawal by Subject
|
14
|
11
|
0
|
0
|
|
Step 1
Physician Decision
|
5
|
2
|
0
|
0
|
|
Step 1
Alternative therapy
|
31
|
43
|
1
|
0
|
|
Step 1
Other disease
|
2
|
1
|
1
|
0
|
|
Step 1
Never started treatment
|
0
|
2
|
0
|
0
|
|
Step 1
Still on treatment as of this analysis
|
14
|
27
|
0
|
0
|
|
Step 1
Knee surgery
|
1
|
0
|
0
|
0
|
|
Step 1
Complications
|
1
|
0
|
0
|
0
|
|
Step 1
Cannot comply due to other tx
|
0
|
1
|
0
|
0
|
|
Step 1
Both patient and physician's decision
|
2
|
1
|
0
|
0
|
|
Step 1
Incorrect disease assessment
|
2
|
0
|
0
|
0
|
|
Step 1
Off treatment for > specified timeframe
|
1
|
1
|
0
|
0
|
|
Step 1
Declining performance status
|
0
|
1
|
0
|
0
|
|
Step 1
Insurance issue
|
0
|
1
|
0
|
0
|
|
Step 1
Rising paraprotein
|
0
|
1
|
0
|
0
|
|
Step 1
Referred to other physicians
|
0
|
1
|
0
|
0
|
|
Step 1
Criteria to continue treatment not met
|
0
|
1
|
0
|
0
|
|
Step 1
Misinterpretation of lab data
|
0
|
1
|
0
|
0
|
|
Step 1
Patient fell with fracture
|
1
|
0
|
0
|
0
|
|
Step 1
Not documented
|
0
|
1
|
0
|
0
|
|
Step 2
Disease progression
|
1
|
4
|
0
|
0
|
|
Step 2
Adverse Event
|
2
|
0
|
0
|
0
|
|
Step 2
Withdrawal by Subject
|
0
|
2
|
0
|
0
|
|
Step 2
Physician Decision
|
0
|
1
|
0
|
0
|
|
Step 2
Alternative therapy
|
1
|
2
|
0
|
0
|
|
Step 2
Never started treatment
|
1
|
1
|
0
|
0
|
Baseline Characteristics
Lenalidomide and Dexamethasone With or Without Thalidomide in Treating Patients With Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Arm I (Lenalidomide, Dexamethasone)
n=223 Participants
Patients receive oral lenalidomide once daily on days 1-21, oral aspirin (or other deep vein thrombosis prophylaxis at the discretion of the principal investigator) once daily on days 1-28, and standard-dose oral dexamethasone once daily on days 1-4, 9-12, and 17-20. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and high-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1-4, 9-12, and 17-20 for 4 cycles.
As the expansion phase was a substudy terminated early with only 7 patients enrolled, the clinical results presented are mainly for the first phase only. Toxicity data are available for both the first phase and the expansion phase.
|
Arm II (Lenalidomide, Low-dose Dexamethasone)
n=222 Participants
Patients receive oral lenalidomide and acetylsalicylic acid as in arm I and low-dose oral dexamethasone once daily on days 1, 8, 15, and 22. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and low-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1, 8, 15, and 22 for 4 cycles.
As the expansion phase was a substudy terminated early with only 7 patients enrolled, the clinical results presented are mainly for the first phase only. Toxicity data are available for both the first phase and the expansion phase.
|
Total
n=445 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66 years
n=30 Participants
|
65 years
n=30 Participants
|
65 years
n=60 Participants
|
|
Sex: Female, Male
Female
|
91 Participants
n=30 Participants
|
101 Participants
n=30 Participants
|
192 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
132 Participants
n=30 Participants
|
121 Participants
n=30 Participants
|
253 Participants
n=60 Participants
|
PRIMARY outcome
Timeframe: Assessed every 4 weeks for 16 weeks during Step 1Population: Only eligible patients were included in this analysis.
Objective response is defined as either complete response (CR) or partial response (PR). Patients who have complete disappearance of an M-protein and no evidence of myeloma in the bone marrow are considered to have CR. PR requires all the following: (1) ≥50% reduction in the level of the serum monoclonal paraprotein. (2) Reduction in 24-hour urinary light chain excretion either by ≥90% or to \<200 mg. (3)For patients with non-secretory (or oligosecretory) myeloma only, a ≥50% reduction in plasma cells in a bone marrow aspirate and on trephine biopsy must be documented. (4)50% reduction in size of soft tissue plasmacytoma (by radiography or clinical examination). (5) No increase in the number or size of lytic bone lesions (development of a compression fracture does not exclude response). As the expansion phase was a substudy terminated early with only 7 patients enrolled, the clinical results presented are mainly for the first phase only.
Outcome measures
| Measure |
Arm I (Lenalidomide, Dexamethasone)
n=214 Participants
Patients receive oral lenalidomide once daily on days 1-21, oral aspirin (or other deep vein thrombosis prophylaxis at the discretion of the principal investigator) once daily on days 1-28, and standard-dose oral dexamethasone once daily on days 1-4, 9-12, and 17-20. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and high-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1-4, 9-12, and 17-20 for 4 cycles.
|
Arm II (Lenalidomide, Low-dose Dexamethasone)
n=208 Participants
Patients receive oral lenalidomide and acetylsalicylic acid as in arm I and low-dose oral dexamethasone once daily on days 1, 8, 15, and 22. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and low-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1, 8, 15, and 22 for 4 cycles.
|
|---|---|---|
|
Proportion of Patients With Objective Response (First Phase, Step 1)
|
0.79 Proportion of patients
Interval 0.729 to 0.842
|
0.683 Proportion of patients
Interval 0.615 to 0.745
|
SECONDARY outcome
Timeframe: Assessed every 4 weeks for 16 weeks during Step 2Population: Only eligible patients were included in this analysis.
Objective response is defined as either complete response (CR) or partial response (PR). Patients who have complete disappearance of an M-protein and no evidence of myeloma in the bone marrow are considered to have CR. PR requires all the following: (1) ≥50% reduction in the level of the serum monoclonal paraprotein. (2) Reduction in 24-hour urinary light chain excretion either by ≥90% or to \<200 mg. (3)For patients with non-secretory (or oligosecretory) myeloma only, a ≥50% reduction in plasma cells in a bone marrow aspirate and on trephine biopsy must be documented. (4)50% reduction in size of soft tissue plasmacytoma (by radiography or clinical examination). (5) No increase in the number or size of lytic bone lesions (development of a compression fracture does not exclude response). As the expansion phase was a substudy terminated early with only 7 patients enrolled, the clinical results presented are mainly for the first phase only.
Outcome measures
| Measure |
Arm I (Lenalidomide, Dexamethasone)
n=2 Participants
Patients receive oral lenalidomide once daily on days 1-21, oral aspirin (or other deep vein thrombosis prophylaxis at the discretion of the principal investigator) once daily on days 1-28, and standard-dose oral dexamethasone once daily on days 1-4, 9-12, and 17-20. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and high-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1-4, 9-12, and 17-20 for 4 cycles.
|
Arm II (Lenalidomide, Low-dose Dexamethasone)
n=9 Participants
Patients receive oral lenalidomide and acetylsalicylic acid as in arm I and low-dose oral dexamethasone once daily on days 1, 8, 15, and 22. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and low-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1, 8, 15, and 22 for 4 cycles.
|
|---|---|---|
|
Proportion of Patients With Objective Response (First Phase, Step 2)
|
0 Proportion of patients
Interval 0.0 to 0.842
|
0 Proportion of patients
Interval 0.0 to 0.336
|
Adverse Events
Arm I (Lenalidomide, Dexamethasone) Step 1
Serious events: 146 serious events
Other events: 222 other events
Deaths: 0 deaths
Arm II (Lenalidomide, Low-dose Dexamethasone) Step 1
Serious events: 112 serious events
Other events: 216 other events
Deaths: 0 deaths
Arm I (Lenalidomide, Dexamethasone) Step 2
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Arm II (Lenalidomide, Low-dose Dexamethasone) Step 2
Serious events: 3 serious events
Other events: 14 other events
Deaths: 0 deaths
Arm III (Expansion; Lenalidomide, Dexamethasone, Aspirin)
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Arm IV (Expansion; Lenalidomide, Dexamethasone, Coumadin)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I (Lenalidomide, Dexamethasone) Step 1
n=223 participants at risk
Patients receive oral lenalidomide once daily on days 1-21, oral aspirin (or other deep vein thrombosis prophylaxis at the discretion of the principal investigator) once daily on days 1-28, and standard-dose oral dexamethasone once daily on days 1-4, 9-12, and 17-20. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and high-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1-4, 9-12, and 17-20 for 4 cycles.
|
Arm II (Lenalidomide, Low-dose Dexamethasone) Step 1
n=220 participants at risk
Patients receive oral lenalidomide and acetylsalicylic acid as in arm I and low-dose oral dexamethasone once daily on days 1, 8, 15, and 22. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and low-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1, 8, 15, and 22 for 4 cycles.
|
Arm I (Lenalidomide, Dexamethasone) Step 2
n=4 participants at risk
Arm I patients with minimal response or no response after 4 cycles of treatment in Step 1 could register for Step 2 treatment with thalidomide and high-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1-4, 9-12, and 17-20 for 4 cycles.
|
Arm II (Lenalidomide, Low-dose Dexamethasone) Step 2
n=14 participants at risk
Arm II patients with minimal response or no response after 4 cycles of treatment in Step 1 could register for Step 2 treatment with thalidomide and low-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1, 8, 15, and 22 for 4 cycles.
|
Arm III (Expansion; Lenalidomide, Dexamethasone, Aspirin)
n=4 participants at risk
Patients receive oral lenalidomide once daily on days 1-21, oral aspirin (or other deep vein thrombosis prophylaxis at the discretion of the principal investigator) once daily on days 1-28, and standard-dose oral dexamethasone once daily on days 1-4, 9-12, and 17-20. After 4 cycles of treatment, patients may discontinue treatment or continue until progression.
|
Arm IV (Expansion; Lenalidomide, Dexamethasone, Coumadin)
n=3 participants at risk
Patients receive oral lenalidomide once daily on days 1-21, oral aspirin (or other deep vein thrombosis prophylaxis at the discretion of the principal investigator) once daily on days 1-28, and standard-dose oral dexamethasone once daily on days 1-4, 9-12, and 17-20. After 4 cycles of treatment, patients may discontinue treatment. For patients continuing therapy beyond 4 cycles, coumadin was discontinued and aspirin was given instead.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Esophagitis
|
0.45%
1/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.45%
1/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Fistula, Ileum
|
0.45%
1/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Gastritis
|
0.45%
1/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.45%
1/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.45%
1/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Vascular disorders
Hemorrhage-other
|
0.45%
1/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
General disorders
Edema trunk/genital
|
0.45%
1/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.45%
1/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Cardiac disorders
Supraventricular arrhythmia NOS
|
0.45%
1/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.45%
1/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Cardiac disorders
Cardiac-ischemia
|
3.1%
7/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.45%
1/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Cardiac disorders
Cardiac troponin T (cTnT)
|
0.45%
1/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Vascular disorders
Hypertension
|
0.90%
2/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
1.8%
4/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Vascular disorders
Hypotension
|
0.90%
2/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.91%
2/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
33.3%
1/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Psychiatric disorders
Insomnia
|
2.2%
5/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.91%
2/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
General disorders
Rigors/chills
|
0.45%
1/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Investigations
Weight gain
|
0.00%
0/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.45%
1/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Investigations
Weight loss
|
0.45%
1/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.45%
1/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
4.0%
9/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.45%
1/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Constipation
|
0.45%
1/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.45%
1/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
4.0%
9/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.91%
2/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
33.3%
1/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
1.8%
4/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
1.4%
3/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Investigations
Alkaline phosphatase increased
|
0.45%
1/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.45%
1/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Investigations
Alanine aminotransferase (ALT) increased
|
2.7%
6/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
1.8%
4/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
11.2%
25/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
5.9%
13/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.90%
2/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Investigations
Lipase increased
|
0.45%
1/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.90%
2/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
1.4%
3/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
7.6%
17/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
3.6%
8/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.4%
12/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
1.4%
3/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory - other
|
0.00%
0/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.45%
1/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Psychiatric disorders
Confusion
|
1.8%
4/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.91%
2/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
33.3%
1/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Nervous system disorders
Dizziness
|
2.7%
6/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
1.4%
3/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
7.1%
1/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Nervous system disorders
Encephalopathy
|
0.45%
1/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Nervous system disorders
Extrapyramidal movement
|
0.00%
0/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.45%
1/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Nervous system disorders
Memory impairment
|
1.3%
3/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Psychiatric disorders
Agitation
|
0.90%
2/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.45%
1/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Psychiatric disorders
Anxiety
|
0.45%
1/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.91%
2/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Psychiatric disorders
Depression
|
3.1%
7/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
1.8%
4/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Eye disorders
Vision-blurred
|
1.3%
3/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Abdomen, pain
|
0.45%
1/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.45%
1/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
General disorders
Pain - other
|
0.00%
0/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.45%
1/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Vascular disorders
Vasculitis
|
0.45%
1/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
2.2%
5/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
7.1%
1/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Cardiac disorders
Atrial flutter
|
0.90%
2/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.45%
1/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Cardiac disorders
Left ventricular diastolic dysfunction
|
0.45%
1/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
1.3%
3/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.45%
1/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
General disorders
Fatigue
|
14.8%
33/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
9.5%
21/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
25.0%
1/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
33.3%
1/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
General disorders
Fever w/o neutropenia
|
0.00%
0/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.45%
1/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Blood and lymphatic system disorders
Thrombotic microangiopathy
|
0.45%
1/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.45%
1/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
0.00%
0/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
1.4%
3/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
2.2%
5/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
4.1%
9/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
0.00%
0/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.45%
1/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.45%
1/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
General disorders
Death - sudden death
|
0.00%
0/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.45%
1/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.45%
1/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Metabolism and nutrition disorders
Pancreatic glucose intolerance
|
0.45%
1/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Endocrine disorders
Endocrine-other
|
0.00%
0/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.45%
1/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Muco/stomatitis (symptom) oral cavity
|
0.00%
0/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.45%
1/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Nausea
|
1.3%
3/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
1.8%
4/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Perforation, colon
|
0.90%
2/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Ulcer, gastric
|
0.45%
1/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.45%
1/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Vomiting
|
1.3%
3/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
1.4%
3/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
33.3%
1/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Gastrointestinal (GI) - other
|
0.45%
1/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.45%
1/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Duodenum, hemorrhage
|
0.45%
1/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Rectum, hemorrhage
|
0.45%
1/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.45%
1/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Lung, hemorrhage
|
0.45%
1/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nose, hemorrhage
|
0.00%
0/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.45%
1/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.45%
1/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.45%
1/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Infections and infestations
Infection w/ grade 3-4 neutropenia, colon
|
0.00%
0/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.45%
1/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Infections and infestations
Infection with grade 3-4 neutropenia, lung
|
0.45%
1/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
1.8%
4/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
33.3%
1/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Infections and infestations
Infection with grade 3-4 neutropenia, upper airway
|
0.00%
0/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.91%
2/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Infections and infestations
Infection with grade 3-4 neutropenia, urinary tract
|
0.00%
0/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.45%
1/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
33.3%
1/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Infections and infestations
Infection with grade 0-2 neutropenia, brain
|
0.45%
1/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Infections and infestations
Infection with grade 0-2 neutropenia, bronchus
|
0.00%
0/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.91%
2/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Infections and infestations
Infection with grade 0-2 neutropenia, colon
|
0.00%
0/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
33.3%
1/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Infections and infestations
Infection with grade 0-2 neutropenia, esophagus
|
0.45%
1/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Infections and infestations
Infection with grade 0-2 neutropenia, lip/perioral
|
0.00%
0/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.45%
1/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Infections and infestations
Infection with grade 0-2 neutropenia, lung
|
4.9%
11/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.45%
1/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Infections and infestations
Infection with grade 0-2 neutropenia, middle ear
|
0.00%
0/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.45%
1/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Infections and infestations
Infection with grade 0-2 neutropenia, skin
|
2.7%
6/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
1.8%
4/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Infections and infestations
Infection with grade 0-2 neutropenia, urinary tract
|
0.90%
2/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.45%
1/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Infections and infestations
Colon infection with unknown absolute neutrophil count (ANC)
|
0.45%
1/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Infections and infestations
Lung infection with unknown absolute neutrophil count (ANC)
|
0.45%
1/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
1.4%
3/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Infections and infestations
Wound infection with unknown absolute neutrophil count (ANC)
|
0.00%
0/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.45%
1/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Infections and infestations
Opportunistic infection associated with >= Grade 1 lymphopenia
|
0.45%
1/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Infections and infestations
Infection with grade 3-4 neutropenia, blood
|
1.3%
3/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.45%
1/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Infections and infestations
Infection with grade 0-2 neutropenia, blood
|
1.3%
3/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.45%
1/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Infections and infestations
Infection w/ unk ANC blood
|
0.45%
1/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Infections and infestations
Infection - other
|
0.45%
1/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.45%
1/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
General disorders
Edema head and neck
|
0.90%
2/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
General disorders
Edema limb
|
6.3%
14/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
1.4%
3/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
7.1%
1/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
25.0%
1/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Investigations
Aspartate aminotransferase (AST) increased
|
1.3%
3/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.91%
2/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Investigations
Bilirubin increased
|
0.45%
1/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.45%
1/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.45%
1/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.45%
1/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
7.2%
16/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
3.6%
8/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Investigations
Creatinine increased
|
2.7%
6/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
1.8%
4/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
33.3%
1/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.45%
1/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.45%
1/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.45%
1/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.90%
2/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Eye disorders
Nonneuropathic extraocular muscle weak
|
4.9%
11/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
1.8%
4/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Nonneuropathic lower extr muscle weak
|
0.90%
2/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.45%
1/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Nonneuropathic generalized weakness
|
5.8%
13/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
1.8%
4/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
25.0%
1/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Nervous system disorders
Ataxia
|
0.45%
1/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Nervous system disorders
Central nervous system (CNS) cerebrovascular ischemia
|
0.45%
1/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.45%
1/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Nervous system disorders
Cognitive disturbance
|
0.45%
1/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.45%
1/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Nervous system disorders
Neuropathy cranial nerves (CN) II vision
|
0.00%
0/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.45%
1/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Nervous system disorders
Neuropathy-motor
|
0.90%
2/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.45%
1/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Nervous system disorders
Neuropathy-sensory
|
0.90%
2/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
1.4%
3/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Psychiatric disorders
Psychosis
|
0.45%
1/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Nervous system disorders
Seizure
|
0.45%
1/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.45%
1/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.45%
1/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.45%
1/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Nervous system disorders
Speech impairment
|
0.45%
1/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Nervous system disorders
Syncope
|
0.90%
2/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.45%
1/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
7.1%
1/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Nervous system disorders
Tremor
|
1.8%
4/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.45%
1/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Eye disorders
Cataract
|
0.90%
2/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
1.8%
4/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.8%
4/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.45%
1/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.45%
1/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Cardiac disorders
Cardiac/heart, pain
|
0.45%
1/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.45%
1/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
General disorders
Chest/thoracic pain NOS
|
0.45%
1/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.45%
1/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Extremity-limb, pain
|
0.90%
2/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Nervous system disorders
Headache
|
0.45%
1/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.91%
2/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
0.45%
1/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.91%
2/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle pain
|
0.90%
2/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Nervous system disorders
Neuropathic, pain
|
0.45%
1/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Adult Respiratory Distress Syndrome (ARDS)
|
0.00%
0/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.45%
1/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.45%
1/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.3%
14/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
1.8%
4/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
50.0%
2/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs
|
0.45%
1/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.3%
3/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.91%
2/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
33.3%
1/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
0.00%
0/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.45%
1/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
3.6%
8/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.91%
2/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory-other
|
0.90%
2/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Renal and urinary disorders
Renal failure
|
1.8%
4/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.45%
1/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
33.3%
1/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Metabolism and nutrition disorders
Urinary electrolyte wasting
|
0.45%
1/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Renal and urinary disorders
Urinary retention
|
0.45%
1/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Injury, poisoning and procedural complications
Vascular access,Thrombosis/embolism
|
0.45%
1/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.45%
1/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
7.1%
1/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
25.1%
56/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
12.7%
28/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
25.0%
1/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Vascular disorders
Vascular-Other
|
0.45%
1/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
Other adverse events
| Measure |
Arm I (Lenalidomide, Dexamethasone) Step 1
n=223 participants at risk
Patients receive oral lenalidomide once daily on days 1-21, oral aspirin (or other deep vein thrombosis prophylaxis at the discretion of the principal investigator) once daily on days 1-28, and standard-dose oral dexamethasone once daily on days 1-4, 9-12, and 17-20. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and high-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1-4, 9-12, and 17-20 for 4 cycles.
|
Arm II (Lenalidomide, Low-dose Dexamethasone) Step 1
n=220 participants at risk
Patients receive oral lenalidomide and acetylsalicylic acid as in arm I and low-dose oral dexamethasone once daily on days 1, 8, 15, and 22. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and low-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1, 8, 15, and 22 for 4 cycles.
|
Arm I (Lenalidomide, Dexamethasone) Step 2
n=4 participants at risk
Arm I patients with minimal response or no response after 4 cycles of treatment in Step 1 could register for Step 2 treatment with thalidomide and high-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1-4, 9-12, and 17-20 for 4 cycles.
|
Arm II (Lenalidomide, Low-dose Dexamethasone) Step 2
n=14 participants at risk
Arm II patients with minimal response or no response after 4 cycles of treatment in Step 1 could register for Step 2 treatment with thalidomide and low-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1, 8, 15, and 22 for 4 cycles.
|
Arm III (Expansion; Lenalidomide, Dexamethasone, Aspirin)
n=4 participants at risk
Patients receive oral lenalidomide once daily on days 1-21, oral aspirin (or other deep vein thrombosis prophylaxis at the discretion of the principal investigator) once daily on days 1-28, and standard-dose oral dexamethasone once daily on days 1-4, 9-12, and 17-20. After 4 cycles of treatment, patients may discontinue treatment or continue until progression.
|
Arm IV (Expansion; Lenalidomide, Dexamethasone, Coumadin)
n=3 participants at risk
Patients receive oral lenalidomide once daily on days 1-21, oral aspirin (or other deep vein thrombosis prophylaxis at the discretion of the principal investigator) once daily on days 1-28, and standard-dose oral dexamethasone once daily on days 1-4, 9-12, and 17-20. After 4 cycles of treatment, patients may discontinue treatment. For patients continuing therapy beyond 4 cycles, coumadin was discontinued and aspirin was given instead.
|
|---|---|---|---|---|---|---|
|
General disorders
Fatigue
|
59.2%
132/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
61.8%
136/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
50.0%
2/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
71.4%
10/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
75.0%
3/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
33.3%
1/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
General disorders
Fever w/o neutropenia
|
10.3%
23/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
5.5%
12/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Psychiatric disorders
Insomnia
|
34.1%
76/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
38.2%
84/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
14.3%
2/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
50.0%
2/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
33.3%
1/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Skin and subcutaneous tissue disorders
Sweating
|
9.4%
21/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
8.2%
18/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
33.3%
1/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Investigations
Weight gain
|
13.5%
30/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
7.7%
17/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Investigations
Weight loss
|
8.1%
18/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
5.9%
13/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.1%
7/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
1.4%
3/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
33.3%
1/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Vascular disorders
Flushing
|
3.6%
8/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
5.9%
13/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
6.7%
15/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
14.5%
32/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
16.1%
36/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
27.3%
60/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
7.1%
1/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
25.0%
1/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
33.3%
1/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
1.3%
3/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
5.9%
13/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
33.3%
1/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
58.3%
130/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
51.8%
114/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
21.4%
3/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
75.0%
3/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
66.7%
2/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Investigations
Creatinine increased
|
25.6%
57/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
26.4%
58/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
14.3%
2/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
66.7%
2/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
68.6%
153/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
68.6%
151/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
50.0%
2/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
50.0%
7/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
50.0%
2/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
33.3%
1/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
8.1%
18/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
4.5%
10/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
7.6%
17/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
7.3%
16/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
30.5%
68/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
30.5%
67/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
7.1%
1/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
25.0%
1/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
66.7%
2/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
5.8%
13/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
10.0%
22/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
34.1%
76/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
26.8%
59/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
7.1%
1/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
50.0%
2/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
33.3%
1/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Eye disorders
Nonneuropathic extraocular muscle weak
|
22.9%
51/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
12.3%
27/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
25.0%
1/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Nervous system disorders
Dizziness
|
20.2%
45/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
11.4%
25/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
25.0%
1/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Psychiatric disorders
Anxiety
|
8.5%
19/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
2.3%
5/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
25.0%
1/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Psychiatric disorders
Depression
|
24.2%
54/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
19.1%
42/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Nervous system disorders
Neuropathy-sensory
|
37.2%
83/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
30.9%
68/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
25.0%
1/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
28.6%
4/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Nervous system disorders
Tremor
|
20.2%
45/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
16.8%
37/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
50.0%
2/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
14.3%
2/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Eye disorders
Vision - blurred
|
17.5%
39/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
16.4%
36/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
33.3%
1/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
General disorders
Abdomen, pain
|
4.5%
10/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
2.7%
6/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
33.3%
1/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.7%
26/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
10.0%
22/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
25.0%
1/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
25.0%
1/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
17.9%
40/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
17.3%
38/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
25.0%
1/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
14.3%
2/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal cavity/paranasal sinus reaction
|
0.00%
0/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.45%
1/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
25.0%
1/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
33.3%
1/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Nonneuropathic generalized weakness
|
2.7%
6/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
1.4%
3/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
25.0%
1/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Ulcer, gastric
|
2.2%
5/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
3.6%
8/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
7.1%
1/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Nervous system disorders
Ataxia
|
1.8%
4/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.45%
1/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
14.3%
2/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Psychiatric disorders
Confusion
|
4.9%
11/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
3.6%
8/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
25.0%
1/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Vomiting
|
5.8%
13/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
5.9%
13/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
33.3%
1/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.45%
1/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.45%
1/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
25.0%
1/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Investigations
AST increased
|
22.4%
50/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
23.2%
51/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
25.0%
1/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
7.1%
1/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
75.0%
3/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Investigations
Bilirubin increased
|
10.8%
24/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
10.9%
24/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Infections and infestations
Infection with grade 0-2 neutropenia, bladder
|
0.00%
0/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
33.3%
1/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Nausea
|
22.0%
49/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
20.5%
45/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
7.1%
1/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
25.0%
1/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
66.7%
2/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Nervous system disorders
Taste disturbance
|
9.0%
20/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
7.7%
17/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
25.0%
1/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Skin and subcutaneous tissue disorders
Hand-foot reaction
|
0.45%
1/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
25.0%
1/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
12.6%
28/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
8.2%
18/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Constipation
|
33.2%
74/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
39.5%
87/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
75.0%
3/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
57.1%
8/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
33.3%
1/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
16.1%
36/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
20.5%
45/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
66.7%
2/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
10.3%
23/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
8.6%
19/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
25.0%
1/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
33.3%
1/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Infections and infestations
Opportunistic infection associated with >= Grade 1 lymphopenia
|
0.00%
0/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
33.3%
1/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
General disorders
Edema, limb
|
40.4%
90/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
31.4%
69/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
50.0%
2/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
28.6%
4/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
25.0%
1/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
33.3%
1/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Investigations
Alkaline phosphatase increased
|
25.1%
56/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
22.7%
50/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
14.3%
2/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Investigations
ALT increased
|
35.0%
78/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
30.5%
67/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
50.0%
2/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Extremity-limb, pain
|
5.8%
13/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
5.0%
11/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
14.3%
2/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Nervous system disorders
Headache
|
9.4%
21/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
8.2%
18/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle pain
|
6.3%
14/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
8.2%
18/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.5%
10/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
3.2%
7/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
25.0%
1/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.45%
1/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
1.4%
3/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
7.1%
1/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Injury, poisoning and procedural complications
Bruising
|
0.90%
2/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
3.2%
7/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
7.1%
1/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Muco/stomatitis by exam, oral cavity
|
4.0%
9/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
3.6%
8/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
7.1%
1/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Muco/stomatitis (symptom) oral cavity
|
3.1%
7/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
4.1%
9/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
7.1%
1/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Nervous system disorders
Depressed level of consciousness
|
2.2%
5/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
3.2%
7/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
21.4%
3/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
General disorders
Pain NOS
|
0.00%
0/223 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.45%
1/220 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
7.1%
1/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
0.00%
0/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
Additional Information
Study Statistician
ECOG Statistical Office
Phone: 617-632-3012
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60