Trial Outcomes & Findings for Bcl-2 Inhibitor GDC-0199 in Combination With Obinutuzumab and Ibrutinib in Treating Patients With Relapsed, Refractory, or Previously Untreated Chronic Lymphocytic Leukemia (NCT NCT02427451)
NCT ID: NCT02427451
Last Updated: 2026-01-27
Results Overview
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE1/PHASE2
Target enrollment
87 participants
Primary outcome timeframe
28 days (course 3)
Results posted on
2026-01-27
Participant Flow
Patients in the phase 1b dose escalation cohorts were enrolled and sequentially assigned to the appropriate dosing cohort. Enrollment was staggered to allow patients to start the ramp up period of venetoclax for the next cohort prior to the completion of the dose-limiting toxicity (DLT) observation period for the previous cohort. However, no patients escalated to a higher target dose until all patients had completed the DLT observation period from the previous cohort.
Participant milestones
| Measure |
Phase 1b Cohort 100mg Venetoclax (GDC-0199)
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. GDC-0199 is administered through a dose ramp-up throughout course 3 with 20 mg administered in week 1, 50mg in week 2 and 100mg in week 3. The 100mg dose level continues through the rest of the treatment period. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Phase 1b Cohort 200mg Venetoclax (GDC-0199)
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. GDC-0199 is administered through a dose ramp-up throughout course 3 with 20 mg administered in week 1, 50mg in week 2, 100mg in week 3 and 200mg in week 4. The 200mg dose level continues through the rest of the treatment period. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Phase 1b Cohort 400mg Venetoclax (GDC-0199)
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. GDC-0199 is administered through a dose ramp-up throughout course 3 with 20 mg administered in week 1, 50mg in week 2, 100mg in week 3 and 200mg in week 4. The dose of GDC-0199 increases to 400mg starting week 1 of course 4. The 400mg dose level continues through the rest of the treatment period. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Phase 2 Relapsed/Refractory
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. GDC-0199 is administered through a dose ramp-up throughout course 3 with 20 mg administered in week 1, 50mg in week 2, 100mg in week 3 and 200mg in week 4. The dose of GDC-0199 increases to 400mg starting week 1 of course 4. The 400mg dose level continues through the rest of the treatment period. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN1: Phase 2 Treatment Naïve
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. GDC-0199 is administered through a dose ramp-up throughout course 3 with 20 mg administered in week 1, 50mg in week 2, 100mg in week 3 and 200mg in week 4. The dose of GDC-0199 increases to 400mg starting week 1 of course 4. The 400mg dose level continues through the rest of the treatment period. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN2: Phase 2 Treatment Naïve
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. GDC-0199 is administered through a dose ramp-up throughout course 3 with 20 mg administered in week 1, 50mg in week 2, 100mg in week 3 and 200mg in week 4. The dose of GDC-0199 increases to 400mg starting week 1 of course 4. The 400mg dose level continues through the rest of the treatment period. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
6
|
25
|
25
|
25
|
|
Overall Study
COMPLETED
|
3
|
3
|
6
|
22
|
21
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
3
|
4
|
1
|
Reasons for withdrawal
| Measure |
Phase 1b Cohort 100mg Venetoclax (GDC-0199)
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. GDC-0199 is administered through a dose ramp-up throughout course 3 with 20 mg administered in week 1, 50mg in week 2 and 100mg in week 3. The 100mg dose level continues through the rest of the treatment period. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Phase 1b Cohort 200mg Venetoclax (GDC-0199)
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. GDC-0199 is administered through a dose ramp-up throughout course 3 with 20 mg administered in week 1, 50mg in week 2, 100mg in week 3 and 200mg in week 4. The 200mg dose level continues through the rest of the treatment period. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Phase 1b Cohort 400mg Venetoclax (GDC-0199)
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. GDC-0199 is administered through a dose ramp-up throughout course 3 with 20 mg administered in week 1, 50mg in week 2, 100mg in week 3 and 200mg in week 4. The dose of GDC-0199 increases to 400mg starting week 1 of course 4. The 400mg dose level continues through the rest of the treatment period. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Phase 2 Relapsed/Refractory
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. GDC-0199 is administered through a dose ramp-up throughout course 3 with 20 mg administered in week 1, 50mg in week 2, 100mg in week 3 and 200mg in week 4. The dose of GDC-0199 increases to 400mg starting week 1 of course 4. The 400mg dose level continues through the rest of the treatment period. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN1: Phase 2 Treatment Naïve
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. GDC-0199 is administered through a dose ramp-up throughout course 3 with 20 mg administered in week 1, 50mg in week 2, 100mg in week 3 and 200mg in week 4. The dose of GDC-0199 increases to 400mg starting week 1 of course 4. The 400mg dose level continues through the rest of the treatment period. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN2: Phase 2 Treatment Naïve
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. GDC-0199 is administered through a dose ramp-up throughout course 3 with 20 mg administered in week 1, 50mg in week 2, 100mg in week 3 and 200mg in week 4. The dose of GDC-0199 increases to 400mg starting week 1 of course 4. The 400mg dose level continues through the rest of the treatment period. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
1
|
2
|
1
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
2
|
2
|
0
|
Baseline Characteristics
Bcl-2 Inhibitor GDC-0199 in Combination With Obinutuzumab and Ibrutinib in Treating Patients With Relapsed, Refractory, or Previously Untreated Chronic Lymphocytic Leukemia
Baseline characteristics by cohort
| Measure |
Phase 1b Cohort 100mg Venetoclax (GDC-0199)
n=3 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. GDC-0199 is administered through a dose ramp-up throughout course 3 with 20 mg administered in week 1, 50mg in week 2 and 100mg in week 3. The 100mg dose level continues through the rest of the treatment period. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Phase 1b Cohort 200mg Venetoclax (GDC-0199)
n=3 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. GDC-0199 is administered through a dose ramp-up throughout course 3 with 20 mg administered in week 1, 50mg in week 2, 100mg in week 3 and 200mg in week 4. The 200mg dose level continues through the rest of the treatment period. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Phase 1b Cohort 400mg Venetoclax (GDC-0199)
n=6 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. GDC-0199 is administered through a dose ramp-up throughout course 3 with 20 mg administered in week 1, 50mg in week 2, 100mg in week 3 and 200mg in week 4. The dose of GDC-0199 increases to 400mg starting week 1 of course 4. The 400mg dose level continues through the rest of the treatment period. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Phase 2 Relapsed/Refractory
n=25 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. GDC-0199 is administered through a dose ramp-up throughout course 3 with 20 mg administered in week 1, 50mg in week 2, 100mg in week 3 and 200mg in week 4. The dose of GDC-0199 increases to 400mg starting week 1 of course 4. The 400mg dose level continues through the rest of the treatment period. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN1: Phase 2 Treatment Naïve
n=25 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. GDC-0199 is administered through a dose ramp-up throughout course 3 with 20 mg administered in week 1, 50mg in week 2, 100mg in week 3 and 200mg in week 4. The dose of GDC-0199 increases to 400mg starting week 1 of course 4. The 400mg dose level continues through the rest of the treatment period. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN2: Phase 2 Treatment Naïve
n=25 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. GDC-0199 is administered through a dose ramp-up throughout course 3 with 20 mg administered in week 1, 50mg in week 2, 100mg in week 3 and 200mg in week 4. The dose of GDC-0199 increases to 400mg starting week 1 of course 4. The 400mg dose level continues through the rest of the treatment period. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Total
n=87 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
0 Participants
n=1267 Participants
|
0 Participants
n=127 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=58 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=41 Participants
|
2 Participants
n=1581 Participants
|
6 Participants
n=4626 Participants
|
19 Participants
n=1267 Participants
|
18 Participants
n=127 Participants
|
20 Participants
n=19 Participants
|
67 Participants
n=58 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
6 Participants
n=1267 Participants
|
7 Participants
n=127 Participants
|
5 Participants
n=19 Participants
|
20 Participants
n=58 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
1 Participants
n=4626 Participants
|
9 Participants
n=1267 Participants
|
10 Participants
n=127 Participants
|
8 Participants
n=19 Participants
|
28 Participants
n=58 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=41 Participants
|
3 Participants
n=1581 Participants
|
5 Participants
n=4626 Participants
|
16 Participants
n=1267 Participants
|
15 Participants
n=127 Participants
|
17 Participants
n=19 Participants
|
59 Participants
n=58 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
0 Participants
n=1267 Participants
|
1 Participants
n=127 Participants
|
0 Participants
n=19 Participants
|
1 Participants
n=58 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=41 Participants
|
3 Participants
n=1581 Participants
|
6 Participants
n=4626 Participants
|
25 Participants
n=1267 Participants
|
24 Participants
n=127 Participants
|
23 Participants
n=19 Participants
|
84 Participants
n=58 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
0 Participants
n=1267 Participants
|
0 Participants
n=127 Participants
|
2 Participants
n=19 Participants
|
2 Participants
n=58 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
0 Participants
n=1267 Participants
|
0 Participants
n=127 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=58 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
1 Participants
n=1267 Participants
|
0 Participants
n=127 Participants
|
0 Participants
n=19 Participants
|
1 Participants
n=58 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
0 Participants
n=1267 Participants
|
0 Participants
n=127 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=58 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
1 Participants
n=1267 Participants
|
0 Participants
n=127 Participants
|
1 Participants
n=19 Participants
|
2 Participants
n=58 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=41 Participants
|
3 Participants
n=1581 Participants
|
6 Participants
n=4626 Participants
|
23 Participants
n=1267 Participants
|
25 Participants
n=127 Participants
|
22 Participants
n=19 Participants
|
82 Participants
n=58 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
0 Participants
n=1267 Participants
|
0 Participants
n=127 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=58 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
0 Participants
n=1267 Participants
|
0 Participants
n=127 Participants
|
2 Participants
n=19 Participants
|
2 Participants
n=58 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=41 Participants
|
3 participants
n=1581 Participants
|
6 participants
n=4626 Participants
|
25 participants
n=1267 Participants
|
25 participants
n=127 Participants
|
25 participants
n=19 Participants
|
87 participants
n=58 Participants
|
PRIMARY outcome
Timeframe: 28 days (course 3)Population: Maximum tolerated dose was only analyzed for phase l
Outcome measures
| Measure |
Phase 1b Cohort
n=12 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Phase 2 Relapsed/Refractory
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN1: Phase 2 Treatment Naïve
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN2: Phase 2 Treatment Naïve
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN1: Phase 2 Treatment Naïve
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN2: Phase 2 Treatment Naïve
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|---|---|---|
|
Maximum Tolerated Dose of Bcl-2 Inhibitor GDC-0199 in Combination With Obinutuzumab and Ibrutinib (Phase Ib)
|
400 milligrams
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 8 weeks post-treatmentPopulation: MRD was only measured for phase 2 of the study
Assessments of MRD will be used in patients classified as CR to further evaluate their status as disease-free and if this further impacts their ability to remain progression-free and alive. MRD will be determined by high sensitivity 4 color flow cytometric analysis of the bone marrow using validated panels.
Outcome measures
| Measure |
Phase 1b Cohort
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Phase 2 Relapsed/Refractory
n=25 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN1: Phase 2 Treatment Naïve
n=25 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN2: Phase 2 Treatment Naïve
n=25 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN1: Phase 2 Treatment Naïve
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN2: Phase 2 Treatment Naïve
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|---|---|---|
|
Minimal Residual Disease (MRD)-Complete Response (CR) Defined by the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 Criteria (Phase II)
|
—
|
44 percentage of participants
|
56 percentage of participants
|
60 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 4 yearsFor all patients who receive at least one day of treatment, toxicities will be tabulated by type and grade and displayed in summary form. Serious adverse events are listed with "(SAE)" after the event name.
Outcome measures
| Measure |
Phase 1b Cohort
n=3 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Phase 2 Relapsed/Refractory
n=3 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN1: Phase 2 Treatment Naïve
n=6 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN2: Phase 2 Treatment Naïve
n=25 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN1: Phase 2 Treatment Naïve
n=25 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN2: Phase 2 Treatment Naïve
n=25 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|---|---|---|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Gastrointestinal Pain
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
2 Number of Events
|
0 Number of Events
|
1 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Hematoma
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
0 Number of Events
|
0 Number of Events
|
4 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Hypersomnia
|
0 Number of Events
|
0 Number of Events
|
2 Number of Events
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Investigations - Other
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Bladder Spasm
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
0 Number of Events
|
1 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Cardiac Disorders - Other
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
3 Number of Events
|
4 Number of Events
|
1 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Dysarthria
|
0 Number of Events
|
0 Number of Events
|
3 Number of Events
|
0 Number of Events
|
1 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Edema Cerebral
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Edema Face
|
0 Number of Events
|
0 Number of Events
|
2 Number of Events
|
1 Number of Events
|
0 Number of Events
|
1 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Edema Limbs
|
0 Number of Events
|
0 Number of Events
|
2 Number of Events
|
9 Number of Events
|
8 Number of Events
|
10 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Flashing Lights
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
1 Number of Events
|
0 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Localized Edema
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
18 Number of Events
|
15 Number of Events
|
8 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Osteoporosis
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
0 Number of Events
|
1 Number of Events
|
2 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Periorbital Edema
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Rectal Hemorrhage
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
1 Number of Events
|
0 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Stomach Pain
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
1 Number of Events
|
1 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Tooth Infection
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
0 Number of Events
|
1 Number of Events
|
1 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Urinary Tract Pain
|
0 Number of Events
|
0 Number of Events
|
2 Number of Events
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Vaginal Infection
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
0 Number of Events
|
2 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Vertigo
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
0 Number of Events
|
0 Number of Events
|
2 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Cholecystitis
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
3 Number of Events
|
0 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Laryngeal inflammation
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
4 Number of Events
|
0 Number of Events
|
1 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Nail Infection
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
3 Number of Events
|
3 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Oral Hemorrhage
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
2 Number of Events
|
2 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Otitis Externa
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
2 Number of Events
|
1 Number of Events
|
1 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Purpura
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
3 Number of Events
|
3 Number of Events
|
1 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Watering Eyes
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
2 Number of Events
|
0 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Fracture
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
3 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Generalized Muscle Weakness
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
4 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Hoarseness
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
3 Number of Events
|
2 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Muscle Weakness Lower Limb
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
3 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Agitation
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
2 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Chest Wall Pain
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
0 Number of Events
|
2 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Erectile Dysfunction
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
0 Number of Events
|
2 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Hiccups
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
0 Number of Events
|
2 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
INR increased
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
2 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Nervous system disorders - Other
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
2 Number of Events
|
1 Number of Events
|
2 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Neuralgia
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
2 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Paronychia
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
5 Number of Events
|
2 Number of Events
|
2 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Blood and lymphatic system disorders - other (SAE)
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Febrile neutropenia
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
0 Number of Events
|
1 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Atrial fibrillation (SAE)
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
2 Number of Events
|
1 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Atrioventricular block complete (SAE)
|
0 Number of Events
|
1 Number of Events
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Cardiac disorders - Other (SAE)
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
0 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Chest pain - cardiac (SAE)
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
2 Number of Events
|
0 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Abdominal pain (SAE)
|
1 Number of Events
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Colitis (SAE)
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Fatigue (SAE)
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
1 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Fever (SAE)
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
0 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Flu like symptoms (SAE)
|
0 Number of Events
|
1 Number of Events
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Cholecystitis (SAE)
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
0 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Bronchial infection (SAE)
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
0 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Infections and infestations - other (SAE)
|
0 Number of Events
|
1 Number of Events
|
1 Number of Events
|
0 Number of Events
|
0 Number of Events
|
3 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Lung Infection (SAE)
|
0 Number of Events
|
1 Number of Events
|
1 Number of Events
|
1 Number of Events
|
1 Number of Events
|
2 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Sepsis (SAE)
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Sinusitis (SAE)
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
0 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Skin infection (SAE)
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
0 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Upper Respiratory Infection (SAE)
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
0 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Infusion related reaction (SAE)
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Stroke (SAE)
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Alanine Aminotransferase increased (SAE)
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Aspartate aminotransferase increased (SAE)
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Neutrophil count decreased (SAE)
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
4 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Dehydration (SAE)
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Hyperkalemia (SAE)
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
2 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Hypoglycemia (SAE)
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Metabolism and nutrition disorders - other (SAE)
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Tumor lysis syndrome (SAE)
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Pain in extremity (SAE)
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
1 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Headache (SAE)
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
0 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Nervous system disorders - other (SAE)
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
1 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Syncope (SAE)
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
0 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Pneumonitis (SAE)
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Wheezing (SAE)
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
0 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Hyperhidrosis (SAE)
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Hypertension (SAE)
|
0 Number of Events
|
1 Number of Events
|
0 Number of Events
|
1 Number of Events
|
0 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Abdominal pain
|
5 Number of Events
|
1 Number of Events
|
1 Number of Events
|
11 Number of Events
|
7 Number of Events
|
6 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Alanine Aminotransferase Increased
|
2 Number of Events
|
4 Number of Events
|
8 Number of Events
|
23 Number of Events
|
12 Number of Events
|
23 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Alkaline Phosphatase Increased
|
2 Number of Events
|
0 Number of Events
|
0 Number of Events
|
6 Number of Events
|
10 Number of Events
|
15 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Allergic Reaction
|
1 Number of Events
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
5 Number of Events
|
2 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Allergic Rhinitis
|
2 Number of Events
|
3 Number of Events
|
3 Number of Events
|
17 Number of Events
|
24 Number of Events
|
3 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Alopecia
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
1 Number of Events
|
3 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Anemia
|
4 Number of Events
|
0 Number of Events
|
0 Number of Events
|
20 Number of Events
|
28 Number of Events
|
16 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Anorexia
|
0 Number of Events
|
2 Number of Events
|
2 Number of Events
|
10 Number of Events
|
21 Number of Events
|
14 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Anxiety
|
0 Number of Events
|
1 Number of Events
|
3 Number of Events
|
14 Number of Events
|
9 Number of Events
|
2 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Arthralgia
|
4 Number of Events
|
5 Number of Events
|
10 Number of Events
|
33 Number of Events
|
37 Number of Events
|
19 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Arthritis
|
2 Number of Events
|
1 Number of Events
|
5 Number of Events
|
6 Number of Events
|
12 Number of Events
|
1 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Aspartate Aminotransferase Increased
|
2 Number of Events
|
3 Number of Events
|
11 Number of Events
|
35 Number of Events
|
22 Number of Events
|
40 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Atrial Fibrillation
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
2 Number of Events
|
4 Number of Events
|
5 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Back Pain
|
3 Number of Events
|
3 Number of Events
|
1 Number of Events
|
16 Number of Events
|
22 Number of Events
|
13 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Blood Bilirubin Increased
|
6 Number of Events
|
0 Number of Events
|
1 Number of Events
|
24 Number of Events
|
43 Number of Events
|
54 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Bloating
|
1 Number of Events
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
1 Number of Events
|
8 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Blurred Vision
|
0 Number of Events
|
0 Number of Events
|
4 Number of Events
|
8 Number of Events
|
11 Number of Events
|
3 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Bone Pain
|
0 Number of Events
|
0 Number of Events
|
2 Number of Events
|
4 Number of Events
|
5 Number of Events
|
3 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Dysphagia
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
3 Number of Events
|
3 Number of Events
|
1 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Ear Pain
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
2 Number of Events
|
5 Number of Events
|
4 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Fatigue
|
4 Number of Events
|
19 Number of Events
|
24 Number of Events
|
66 Number of Events
|
76 Number of Events
|
39 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Flatulence
|
0 Number of Events
|
2 Number of Events
|
1 Number of Events
|
1 Number of Events
|
0 Number of Events
|
2 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Heamaturia
|
1 Number of Events
|
0 Number of Events
|
0 Number of Events
|
5 Number of Events
|
8 Number of Events
|
3 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Proteinuria
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
4 Number of Events
|
1 Number of Events
|
1 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Pruritus
|
1 Number of Events
|
1 Number of Events
|
0 Number of Events
|
2 Number of Events
|
3 Number of Events
|
7 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Syncope
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
2 Number of Events
|
2 Number of Events
|
1 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Upper Respiratory Infection
|
5 Number of Events
|
5 Number of Events
|
8 Number of Events
|
30 Number of Events
|
28 Number of Events
|
11 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Urinary Tract Infection
|
0 Number of Events
|
0 Number of Events
|
2 Number of Events
|
6 Number of Events
|
20 Number of Events
|
3 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Vascular disorders - Other
|
2 Number of Events
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
1 Number of Events
|
1 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
General disorders and administration site conditions - Other
|
0 Number of Events
|
1 Number of Events
|
0 Number of Events
|
1 Number of Events
|
0 Number of Events
|
1 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Bronchial Infection
|
1 Number of Events
|
4 Number of Events
|
0 Number of Events
|
7 Number of Events
|
3 Number of Events
|
2 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Bruising
|
3 Number of Events
|
6 Number of Events
|
12 Number of Events
|
34 Number of Events
|
33 Number of Events
|
30 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Bullous Dermatitis
|
2 Number of Events
|
1 Number of Events
|
0 Number of Events
|
1 Number of Events
|
3 Number of Events
|
1 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Cataract
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
3 Number of Events
|
1 Number of Events
|
5 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Non-cardiac Chest Pain
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
11 Number of Events
|
5 Number of Events
|
9 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Chest Pain - Cardiac
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
4 Number of Events
|
2 Number of Events
|
1 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Chills
|
1 Number of Events
|
1 Number of Events
|
0 Number of Events
|
14 Number of Events
|
20 Number of Events
|
10 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
High Cholesterol
|
1 Number of Events
|
0 Number of Events
|
1 Number of Events
|
7 Number of Events
|
4 Number of Events
|
1 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Chronic Kidney Disease
|
2 Number of Events
|
0 Number of Events
|
1 Number of Events
|
4 Number of Events
|
0 Number of Events
|
1 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Confusion
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
0 Number of Events
|
3 Number of Events
|
2 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Conjunctivitis
|
1 Number of Events
|
0 Number of Events
|
0 Number of Events
|
2 Number of Events
|
2 Number of Events
|
2 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Constipation
|
2 Number of Events
|
2 Number of Events
|
4 Number of Events
|
24 Number of Events
|
32 Number of Events
|
18 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Cough
|
2 Number of Events
|
2 Number of Events
|
4 Number of Events
|
32 Number of Events
|
26 Number of Events
|
21 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Creatinine Increased
|
7 Number of Events
|
7 Number of Events
|
8 Number of Events
|
32 Number of Events
|
27 Number of Events
|
25 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Dental Caries
|
1 Number of Events
|
0 Number of Events
|
2 Number of Events
|
9 Number of Events
|
1 Number of Events
|
1 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Depression
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
9 Number of Events
|
6 Number of Events
|
1 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Diarrhea
|
4 Number of Events
|
5 Number of Events
|
16 Number of Events
|
46 Number of Events
|
44 Number of Events
|
63 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Dizziness
|
2 Number of Events
|
1 Number of Events
|
6 Number of Events
|
11 Number of Events
|
19 Number of Events
|
16 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Dry Eyes
|
1 Number of Events
|
0 Number of Events
|
1 Number of Events
|
5 Number of Events
|
4 Number of Events
|
6 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Dry Mouth
|
1 Number of Events
|
0 Number of Events
|
2 Number of Events
|
1 Number of Events
|
3 Number of Events
|
1 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Dry Skin
|
1 Number of Events
|
0 Number of Events
|
3 Number of Events
|
10 Number of Events
|
9 Number of Events
|
7 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Dysgeusia
|
0 Number of Events
|
1 Number of Events
|
1 Number of Events
|
5 Number of Events
|
6 Number of Events
|
7 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Dyspepsia
|
2 Number of Events
|
4 Number of Events
|
5 Number of Events
|
29 Number of Events
|
44 Number of Events
|
14 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Dyspnea
|
1 Number of Events
|
5 Number of Events
|
11 Number of Events
|
23 Number of Events
|
25 Number of Events
|
14 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Epistaxis
|
0 Number of Events
|
0 Number of Events
|
11 Number of Events
|
17 Number of Events
|
21 Number of Events
|
2 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Fall
|
0 Number of Events
|
0 Number of Events
|
2 Number of Events
|
10 Number of Events
|
10 Number of Events
|
5 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Fever
|
3 Number of Events
|
0 Number of Events
|
3 Number of Events
|
15 Number of Events
|
17 Number of Events
|
10 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Floaters
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
2 Number of Events
|
0 Number of Events
|
2 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Flu Like Symptoms
|
0 Number of Events
|
5 Number of Events
|
5 Number of Events
|
6 Number of Events
|
6 Number of Events
|
21 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Flushing
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
1 Number of Events
|
2 Number of Events
|
2 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Gastroesophageal Reflux Disease
|
0 Number of Events
|
1 Number of Events
|
4 Number of Events
|
2 Number of Events
|
1 Number of Events
|
3 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Headache
|
5 Number of Events
|
6 Number of Events
|
6 Number of Events
|
35 Number of Events
|
27 Number of Events
|
23 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Hearing Impaired
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
2 Number of Events
|
1 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Hemorrhoids
|
0 Number of Events
|
1 Number of Events
|
2 Number of Events
|
1 Number of Events
|
2 Number of Events
|
1 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Hot Flashes
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
2 Number of Events
|
6 Number of Events
|
3 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Hyperglycemia
|
5 Number of Events
|
0 Number of Events
|
7 Number of Events
|
53 Number of Events
|
40 Number of Events
|
31 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Hyperhidrosis
|
4 Number of Events
|
7 Number of Events
|
4 Number of Events
|
17 Number of Events
|
24 Number of Events
|
12 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Hyperkalemia
|
2 Number of Events
|
1 Number of Events
|
0 Number of Events
|
6 Number of Events
|
0 Number of Events
|
7 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Hypernatremia
|
4 Number of Events
|
2 Number of Events
|
1 Number of Events
|
13 Number of Events
|
13 Number of Events
|
3 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Hypertension
|
17 Number of Events
|
26 Number of Events
|
52 Number of Events
|
225 Number of Events
|
207 Number of Events
|
125 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Hyperuricemia
|
6 Number of Events
|
5 Number of Events
|
20 Number of Events
|
55 Number of Events
|
37 Number of Events
|
28 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Hypoalbuminemia
|
0 Number of Events
|
1 Number of Events
|
2 Number of Events
|
15 Number of Events
|
53 Number of Events
|
9 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Hypocalcemia
|
3 Number of Events
|
17 Number of Events
|
11 Number of Events
|
74 Number of Events
|
98 Number of Events
|
56 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Hypoglycemia
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
22 Number of Events
|
21 Number of Events
|
8 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Hypokalemia
|
3 Number of Events
|
1 Number of Events
|
0 Number of Events
|
28 Number of Events
|
40 Number of Events
|
24 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Hypomagnesemia
|
0 Number of Events
|
1 Number of Events
|
0 Number of Events
|
11 Number of Events
|
14 Number of Events
|
12 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Hyponatremia
|
1 Number of Events
|
0 Number of Events
|
0 Number of Events
|
19 Number of Events
|
16 Number of Events
|
18 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Hypophosphatemia
|
5 Number of Events
|
5 Number of Events
|
13 Number of Events
|
19 Number of Events
|
11 Number of Events
|
14 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Hypothyroidism
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
1 Number of Events
|
3 Number of Events
|
1 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Infusion Related Reaction
|
3 Number of Events
|
6 Number of Events
|
4 Number of Events
|
21 Number of Events
|
25 Number of Events
|
25 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Insomnia
|
1 Number of Events
|
5 Number of Events
|
6 Number of Events
|
11 Number of Events
|
23 Number of Events
|
13 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Joint Range of Motion Decreased
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
1 Number of Events
|
2 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Leukocytosis
|
2 Number of Events
|
0 Number of Events
|
0 Number of Events
|
2 Number of Events
|
3 Number of Events
|
2 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Lung Infection
|
0 Number of Events
|
2 Number of Events
|
2 Number of Events
|
4 Number of Events
|
5 Number of Events
|
8 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Lymph Node Pain
|
1 Number of Events
|
1 Number of Events
|
0 Number of Events
|
3 Number of Events
|
5 Number of Events
|
1 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Lymphocyte Count Decreased
|
24 Number of Events
|
29 Number of Events
|
30 Number of Events
|
170 Number of Events
|
162 Number of Events
|
172 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Lymphocyte Count Increased
|
5 Number of Events
|
3 Number of Events
|
1 Number of Events
|
34 Number of Events
|
22 Number of Events
|
31 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Malaise
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
5 Number of Events
|
4 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Mucositis Oral
|
0 Number of Events
|
5 Number of Events
|
4 Number of Events
|
25 Number of Events
|
42 Number of Events
|
33 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Myalgia
|
3 Number of Events
|
1 Number of Events
|
13 Number of Events
|
41 Number of Events
|
40 Number of Events
|
29 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Nail Loss
|
0 Number of Events
|
2 Number of Events
|
1 Number of Events
|
8 Number of Events
|
6 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Nasal Congestion
|
2 Number of Events
|
2 Number of Events
|
3 Number of Events
|
12 Number of Events
|
10 Number of Events
|
10 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Nausea
|
1 Number of Events
|
2 Number of Events
|
8 Number of Events
|
32 Number of Events
|
41 Number of Events
|
34 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Neck Pain
|
1 Number of Events
|
2 Number of Events
|
0 Number of Events
|
1 Number of Events
|
5 Number of Events
|
2 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Neutrophil Count Decreased
|
18 Number of Events
|
34 Number of Events
|
24 Number of Events
|
229 Number of Events
|
169 Number of Events
|
169 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Oral Pain
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
1 Number of Events
|
7 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Otitis Media
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
3 Number of Events
|
3 Number of Events
|
5 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Pain
|
4 Number of Events
|
0 Number of Events
|
6 Number of Events
|
9 Number of Events
|
8 Number of Events
|
6 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Palpitations
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
7 Number of Events
|
4 Number of Events
|
7 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Paresthesia
|
1 Number of Events
|
3 Number of Events
|
2 Number of Events
|
15 Number of Events
|
21 Number of Events
|
19 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Peripheral Sensory Neuropathy
|
0 Number of Events
|
1 Number of Events
|
3 Number of Events
|
4 Number of Events
|
2 Number of Events
|
1 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Platelet Count Decreased
|
21 Number of Events
|
12 Number of Events
|
58 Number of Events
|
177 Number of Events
|
175 Number of Events
|
103 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Postnasal Drip
|
1 Number of Events
|
0 Number of Events
|
1 Number of Events
|
12 Number of Events
|
7 Number of Events
|
7 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Productive Cough
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
6 Number of Events
|
1 Number of Events
|
6 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Rash Acneiform
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
3 Number of Events
|
5 Number of Events
|
3 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Rash Maculo-papular
|
2 Number of Events
|
1 Number of Events
|
4 Number of Events
|
23 Number of Events
|
33 Number of Events
|
12 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Sinus Bradycardia
|
1 Number of Events
|
0 Number of Events
|
2 Number of Events
|
36 Number of Events
|
20 Number of Events
|
29 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Sinus Disorder
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
6 Number of Events
|
1 Number of Events
|
1 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Sinus Pain
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
4 Number of Events
|
2 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Sinus Tachycardia
|
1 Number of Events
|
0 Number of Events
|
0 Number of Events
|
9 Number of Events
|
5 Number of Events
|
10 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Sinusitis
|
2 Number of Events
|
4 Number of Events
|
2 Number of Events
|
35 Number of Events
|
25 Number of Events
|
15 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Skin Infection
|
1 Number of Events
|
0 Number of Events
|
8 Number of Events
|
13 Number of Events
|
11 Number of Events
|
6 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Sleep Apnea
|
0 Number of Events
|
1 Number of Events
|
2 Number of Events
|
2 Number of Events
|
2 Number of Events
|
1 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Sore Throat
|
0 Number of Events
|
1 Number of Events
|
3 Number of Events
|
12 Number of Events
|
17 Number of Events
|
11 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Testicular Pain
|
2 Number of Events
|
0 Number of Events
|
1 Number of Events
|
0 Number of Events
|
1 Number of Events
|
2 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Tinnitus
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
7 Number of Events
|
4 Number of Events
|
2 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Toothache
|
2 Number of Events
|
0 Number of Events
|
1 Number of Events
|
5 Number of Events
|
3 Number of Events
|
4 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Tremor
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
0 Number of Events
|
1 Number of Events
|
4 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Urinary Frequency
|
2 Number of Events
|
1 Number of Events
|
0 Number of Events
|
5 Number of Events
|
8 Number of Events
|
5 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Vomiting
|
0 Number of Events
|
2 Number of Events
|
3 Number of Events
|
19 Number of Events
|
10 Number of Events
|
12 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
White Blood Cell Decreased
|
19 Number of Events
|
34 Number of Events
|
24 Number of Events
|
231 Number of Events
|
184 Number of Events
|
186 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Weight Gain
|
7 Number of Events
|
13 Number of Events
|
6 Number of Events
|
42 Number of Events
|
57 Number of Events
|
51 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Weight Loss
|
1 Number of Events
|
2 Number of Events
|
10 Number of Events
|
11 Number of Events
|
10 Number of Events
|
8 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Activated partial thromboplastin time prolonged
|
2 Number of Events
|
0 Number of Events
|
1 Number of Events
|
1 Number of Events
|
0 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Blood and lymphatic system disorders - Other
|
1 Number of Events
|
1 Number of Events
|
0 Number of Events
|
2 Number of Events
|
0 Number of Events
|
3 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Ear and labyrinth disorders - Other
|
1 Number of Events
|
0 Number of Events
|
0 Number of Events
|
6 Number of Events
|
2 Number of Events
|
5 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Eye Disorders - Other
|
1 Number of Events
|
1 Number of Events
|
0 Number of Events
|
6 Number of Events
|
3 Number of Events
|
12 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Flank Pain
|
1 Number of Events
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
2 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Gastrointestinal disorders - Other
|
2 Number of Events
|
0 Number of Events
|
2 Number of Events
|
14 Number of Events
|
18 Number of Events
|
8 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Gum Infection
|
2 Number of Events
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
2 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Injury, poisoning and procedural complications - Other
|
1 Number of Events
|
1 Number of Events
|
11 Number of Events
|
9 Number of Events
|
17 Number of Events
|
10 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Musculoskeletal and connective tissue disorder - Other
|
5 Number of Events
|
4 Number of Events
|
6 Number of Events
|
17 Number of Events
|
8 Number of Events
|
7 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other
|
2 Number of Events
|
3 Number of Events
|
3 Number of Events
|
29 Number of Events
|
28 Number of Events
|
37 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Pain in Extremity
|
1 Number of Events
|
1 Number of Events
|
2 Number of Events
|
22 Number of Events
|
13 Number of Events
|
9 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Pneumonitis
|
2 Number of Events
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
3 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Renal and urinary disorders - Other
|
2 Number of Events
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
1 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Skin and subcutaneous tissue disorders - Other
|
4 Number of Events
|
2 Number of Events
|
12 Number of Events
|
24 Number of Events
|
23 Number of Events
|
29 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Surgical and medical procedures - Other
|
1 Number of Events
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Urinary Retention
|
1 Number of Events
|
0 Number of Events
|
0 Number of Events
|
3 Number of Events
|
0 Number of Events
|
2 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Atrioventricular block complete
|
0 Number of Events
|
1 Number of Events
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Cognitive Disturbance
|
0 Number of Events
|
1 Number of Events
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Eye Infection
|
0 Number of Events
|
1 Number of Events
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Hypertriglyceridemia
|
0 Number of Events
|
1 Number of Events
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Infections and infestations - Other
|
0 Number of Events
|
1 Number of Events
|
3 Number of Events
|
17 Number of Events
|
28 Number of Events
|
35 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Memory Impairment
|
0 Number of Events
|
1 Number of Events
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Metabolism and nutrition disorders - Other
|
0 Number of Events
|
1 Number of Events
|
2 Number of Events
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Nail Ridging
|
0 Number of Events
|
1 Number of Events
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Reproductive system and breast disorders - Other
|
0 Number of Events
|
1 Number of Events
|
0 Number of Events
|
1 Number of Events
|
2 Number of Events
|
5 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Respiratory, thoracic and mediastinal disorders - Other
|
0 Number of Events
|
2 Number of Events
|
0 Number of Events
|
1 Number of Events
|
2 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Rhinitis infective
|
0 Number of Events
|
1 Number of Events
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Urinary Urgency
|
0 Number of Events
|
1 Number of Events
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
|
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Anal Hemorrhage
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
1 Number of Events
|
0 Number of Events
|
1 Number of Events
|
SECONDARY outcome
Timeframe: Up to 14 monthsMay be summarized.
Outcome measures
| Measure |
Phase 1b Cohort
n=3 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Phase 2 Relapsed/Refractory
n=3 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN1: Phase 2 Treatment Naïve
n=6 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN2: Phase 2 Treatment Naïve
n=25 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN1: Phase 2 Treatment Naïve
n=25 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN2: Phase 2 Treatment Naïve
n=25 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|---|---|---|
|
Number of Courses Started/Completed
Completed 14 cycles
|
3 number of subjects
|
3 number of subjects
|
6 number of subjects
|
22 number of subjects
|
21 number of subjects
|
24 number of subjects
|
|
Number of Courses Started/Completed
Completed 13 or less cycles
|
0 number of subjects
|
0 number of subjects
|
0 number of subjects
|
3 number of subjects
|
4 number of subjects
|
1 number of subjects
|
SECONDARY outcome
Timeframe: Up to 14 monthsPopulation: Target dose of Bcl-2 inhibitor GDC-0199 only measured for Phase ll subjects
May be summarized.
Outcome measures
| Measure |
Phase 1b Cohort
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Phase 2 Relapsed/Refractory
n=25 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN1: Phase 2 Treatment Naïve
n=25 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN2: Phase 2 Treatment Naïve
n=25 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN1: Phase 2 Treatment Naïve
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN2: Phase 2 Treatment Naïve
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|---|---|---|
|
Number of Patients Who Reach the Target Dose of Bcl-2 Inhibitor GDC-0199
|
—
|
24 Participants
|
25 Participants
|
25 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 14 monthsMay be summarized.
Outcome measures
| Measure |
Phase 1b Cohort
n=3 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Phase 2 Relapsed/Refractory
n=3 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN1: Phase 2 Treatment Naïve
n=6 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN2: Phase 2 Treatment Naïve
n=25 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN1: Phase 2 Treatment Naïve
n=25 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN2: Phase 2 Treatment Naïve
n=25 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|---|---|---|
|
Number of Patients Requiring Dose Reductions
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Up to 14 monthsMay be summarized.
Outcome measures
| Measure |
Phase 1b Cohort
n=3 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Phase 2 Relapsed/Refractory
n=3 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN1: Phase 2 Treatment Naïve
n=6 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN2: Phase 2 Treatment Naïve
n=25 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN1: Phase 2 Treatment Naïve
n=25 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN2: Phase 2 Treatment Naïve
n=25 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|---|---|---|
|
Reason for Going Off Treatment
Adverse Event
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
2 participants
|
1 participants
|
|
Reason for Going Off Treatment
Physician Decision
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
2 participants
|
0 participants
|
|
Reason for Going Off Treatment
Treatment completed per protocol
|
3 participants
|
3 participants
|
6 participants
|
22 participants
|
21 participants
|
24 participants
|
SECONDARY outcome
Timeframe: Up to 4 yearsOverall response rate will be reported for all evaluable patients in the phase II setting, within and potentially across cohorts, assuming a binomial distribution.
Outcome measures
| Measure |
Phase 1b Cohort
n=3 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Phase 2 Relapsed/Refractory
n=3 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN1: Phase 2 Treatment Naïve
n=6 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN2: Phase 2 Treatment Naïve
n=25 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN1: Phase 2 Treatment Naïve
n=25 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN2: Phase 2 Treatment Naïve
n=25 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|---|---|---|
|
Overall Response Rate
|
66.7 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
88 percentage of participants
|
84 percentage of participants
|
96 percentage of participants
|
SECONDARY outcome
Timeframe: Time from first treatment date until the date of progression or death, whichever occurs first, assessed up to 8 yearsWill be summarized by the Kaplan-Meier method for each of the phase II cohorts.
Outcome measures
| Measure |
Phase 1b Cohort
n=3 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Phase 2 Relapsed/Refractory
n=3 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN1: Phase 2 Treatment Naïve
n=6 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN2: Phase 2 Treatment Naïve
n=25 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN1: Phase 2 Treatment Naïve
n=25 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN2: Phase 2 Treatment Naïve
n=25 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|---|---|---|
|
Progression-free Survival (PFS)
|
NA months
For the phase 1b cohort, median PFS was not reached due to an insufficient number of events
|
NA months
For the phase 1b cohort, median PFS was not reached due to an insufficient number of events
|
NA months
For the phase 1b cohort, median PFS was not reached due to an insufficient number of events
|
81.8 months
Interval 57.3 to
The upper limit of the confidence interval was not reached due to not enough participants experiencing progression or death
|
88.5 months
Interval 80.6 to
The upper limit of the confidence interval was not reached due to not enough participants experiencing progression or death
|
NA months
For the TN2 cohort, median PFS was not reached due to an insufficient number of events
|
SECONDARY outcome
Timeframe: Cycle 1 day 1, cycle 2 day 1, cycle 3 day 1, cycle 6 day 1 and cycle 12 day 1Population: In the phase 1b study, as not all patients were treated at the target dose of venetoclax, psychologic outcomes were not planned to be collected. In the newest cohort (the TN2 cohort) these studies were similarly not planned or included as adequate information had been gained on the outcomes measures from the original phase 2 cohorts. The number of analyzed participants at each time point represents the number of participants who completed the survey at that time point.
Validated instruments will be administered serially to assess longitudinal changes in measures of health related quality of life using 36-Item Short Form Survey (SF-36) Mental Component Scale (MCS) T-scores for each time point with pairwise comparison p-values. Scores on the SF-36 scale range from 0 to 100, with higher scores indicating better mental health. Scores for the MCS are standardized using U.S. general population norms with summary scores set relative to a t-score mean of 50 and a standard deviation of 10.
Outcome measures
| Measure |
Phase 1b Cohort
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Phase 2 Relapsed/Refractory
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN1: Phase 2 Treatment Naïve
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN2: Phase 2 Treatment Naïve
n=21 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN1: Phase 2 Treatment Naïve
n=23 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN2: Phase 2 Treatment Naïve
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|---|---|---|
|
Emotional Distress Assessment
Cycle 1 Day 1
|
—
|
—
|
—
|
54.03 T-score
Standard Deviation 9.25
|
52.32 T-score
Standard Deviation 6.87
|
—
|
|
Emotional Distress Assessment
Cycle 2 Day 1
|
—
|
—
|
—
|
54.42 T-score
Standard Deviation 7.75
|
54.88 T-score
Standard Deviation 6.10
|
—
|
|
Emotional Distress Assessment
Cycle 3 Day 1
|
—
|
—
|
—
|
55.90 T-score
Standard Deviation 7.05
|
54.33 T-score
Standard Deviation 6.54
|
—
|
|
Emotional Distress Assessment
Cycle 6 Day 1
|
—
|
—
|
—
|
56.31 T-score
Standard Deviation 7.64
|
53.50 T-score
Standard Deviation 8.96
|
—
|
|
Emotional Distress Assessment
Cycle 12 Day 1
|
—
|
—
|
—
|
55.53 T-score
Standard Deviation 5.34
|
54.35 T-score
Standard Deviation 6.30
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 6 Day 1, and Cycle 12 Day 1 (each cycle is 28 days)Population: In the phase 1b study, as not all patients were treated at the target dose of venetoclax, psychologic outcomes were not planned to be collected. In the newest cohort (the TN2 cohort) these studies were similarly not planned or included as adequate information had been gained on the outcomes measures from the original phase 2 cohorts. The number of analyzed participants at each time point represents the number of participants who completed the survey at that time point.
Validated instruments will be administered serially to assess longitudinal changes in measures of health related quality of life using 36-Item Short Form Survey (SF-36) Physical Component Scale (PCS) T-scores for each time point with pairwise comparison p-values. Scores on the SF-36 scale range from 0 to 100, with higher scores indicating better physical health. Scores for the PCS are standardized using U.S. general population norms with summary scores set relative to a t-score mean of 50 and a standard deviation of 10.
Outcome measures
| Measure |
Phase 1b Cohort
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Phase 2 Relapsed/Refractory
n=21 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN1: Phase 2 Treatment Naïve
n=23 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN2: Phase 2 Treatment Naïve
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN1: Phase 2 Treatment Naïve
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN2: Phase 2 Treatment Naïve
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|---|---|---|
|
Health Related Quality of Life
Cycle 1 Day 1
|
—
|
42.88 T-score
Standard Deviation 12.52
|
44.25 T-score
Standard Deviation 10.97
|
—
|
—
|
—
|
|
Health Related Quality of Life
Cycle 2 Day 1
|
—
|
45.53 T-score
Standard Deviation 12.12
|
42.01 T-score
Standard Deviation 10.57
|
—
|
—
|
—
|
|
Health Related Quality of Life
Cycle 3 Day 1
|
—
|
45.17 T-score
Standard Deviation 13.56
|
44.92 T-score
Standard Deviation 11.86
|
—
|
—
|
—
|
|
Health Related Quality of Life
Cycle 6 Day 1
|
—
|
45.94 T-score
Standard Deviation 12.95
|
46.75 T-score
Standard Deviation 11.37
|
—
|
—
|
—
|
|
Health Related Quality of Life
Cycle 12 Day 1
|
—
|
45.97 T-score
Standard Deviation 14.05
|
46.40 T-score
Standard Deviation 11.45
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 4 weeks post-treatmentPopulation: In the phase 1b study, as not all patients were treated at the target dose of venetoclax, immune cell subsets were not planned to be collected. In the TN2 cohort these studies were similarly not planned or included as adequate information had been gained on the outcomes measures from the original phase 2 cohorts. Five participants from the Phase 2 RR cohort and four participants from the TN1 cohort did not complete treatment or were unable to have data collected for immune cell subsets.
Peripheral blood immunophenotyping will be used to enumerate immune effector cells (counts and percentages of T-, and Natural Killer (NK)-cell subsets).
Outcome measures
| Measure |
Phase 1b Cohort
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Phase 2 Relapsed/Refractory
n=20 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN1: Phase 2 Treatment Naïve
n=21 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN2: Phase 2 Treatment Naïve
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN1: Phase 2 Treatment Naïve
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN2: Phase 2 Treatment Naïve
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|---|---|---|
|
Serial Assessment of Immune Effector Cell Number and Function.
CD3+CD8+
|
—
|
479 10^3 cells/uL
Standard Deviation 296
|
312 10^3 cells/uL
Standard Deviation 213
|
—
|
—
|
—
|
|
Serial Assessment of Immune Effector Cell Number and Function.
CD3+CD4+
|
—
|
499 10^3 cells/uL
Standard Deviation 217
|
738 10^3 cells/uL
Standard Deviation 298
|
—
|
—
|
—
|
|
Serial Assessment of Immune Effector Cell Number and Function.
NK
|
—
|
95 10^3 cells/uL
Standard Deviation 64
|
89 10^3 cells/uL
Standard Deviation 49
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: BaselineRelationships between baseline prognostic factors and response may be screened and analyzed quantitatively using logistic regression and adjusting for disease cohort, particularly if a sufficient number of patients respond to this combination therapy.
Outcome measures
| Measure |
Phase 1b Cohort
n=3 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Phase 2 Relapsed/Refractory
n=3 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN1: Phase 2 Treatment Naïve
n=6 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN2: Phase 2 Treatment Naïve
n=25 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN1: Phase 2 Treatment Naïve
n=25 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN2: Phase 2 Treatment Naïve
n=25 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|---|---|---|
|
Baseline Prognostic Factors: Number of Prior Therapies
|
1 Number of Prior Therapies
Interval 1.0 to 7.0
|
1 Number of Prior Therapies
Interval 1.0 to 2.0
|
1 Number of Prior Therapies
Interval 1.0 to 2.0
|
1 Number of Prior Therapies
Interval 1.0 to 3.0
|
0 Number of Prior Therapies
Interval 0.0 to 0.0
|
0 Number of Prior Therapies
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: BaselineRelationships between baseline prognostic factors and response may be screened and analyzed quantitatively using logistic regression and adjusting for disease cohort, particularly if a sufficient number of patients respond to this combination therapy.
Outcome measures
| Measure |
Phase 1b Cohort
n=3 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Phase 2 Relapsed/Refractory
n=3 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN1: Phase 2 Treatment Naïve
n=6 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN2: Phase 2 Treatment Naïve
n=25 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN1: Phase 2 Treatment Naïve
n=25 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN2: Phase 2 Treatment Naïve
n=25 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|---|---|---|
|
Baseline Prognostic Factors: Tumor Lysis Syndrome (TLS) Risk
TLS Risk High
|
1 participants
|
0 participants
|
3 participants
|
10 participants
|
6 participants
|
7 participants
|
|
Baseline Prognostic Factors: Tumor Lysis Syndrome (TLS) Risk
TLS Risk Low
|
0 participants
|
0 participants
|
1 participants
|
7 participants
|
1 participants
|
1 participants
|
|
Baseline Prognostic Factors: Tumor Lysis Syndrome (TLS) Risk
TLS Risk Medium
|
2 participants
|
3 participants
|
2 participants
|
8 participants
|
18 participants
|
17 participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: One participant in the TN2 cohort did not have hemoglobin measured at baseline.
Outcome measures
| Measure |
Phase 1b Cohort
n=3 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Phase 2 Relapsed/Refractory
n=3 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN1: Phase 2 Treatment Naïve
n=6 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN2: Phase 2 Treatment Naïve
n=25 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN1: Phase 2 Treatment Naïve
n=25 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN2: Phase 2 Treatment Naïve
n=24 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|---|---|---|
|
Baseline Prognostic Factors: Hemoglobin
|
12.3 grams per deciliter
Interval 12.3 to 13.3
|
11.4 grams per deciliter
Interval 11.2 to 12.7
|
12.7 grams per deciliter
Interval 11.6 to 15.8
|
12 grams per deciliter
Interval 9.0 to 16.0
|
10 grams per deciliter
Interval 8.0 to 13.0
|
10 grams per deciliter
Interval 7.0 to 15.0
|
SECONDARY outcome
Timeframe: BaselineAbsolute neutrophil count (ANC), Absolute lymphocyte count (ALC) and Platelets.
Outcome measures
| Measure |
Phase 1b Cohort
n=3 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Phase 2 Relapsed/Refractory
n=3 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN1: Phase 2 Treatment Naïve
n=6 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN2: Phase 2 Treatment Naïve
n=25 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN1: Phase 2 Treatment Naïve
n=25 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN2: Phase 2 Treatment Naïve
n=25 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|---|---|---|
|
Baseline Prognostic Factors: Investigations
Platelets
|
117 10^3 cells/uL
Interval 103.0 to 227.0
|
158 10^3 cells/uL
Interval 102.0 to 208.0
|
171.5 10^3 cells/uL
Interval 139.0 to 222.0
|
132 10^3 cells/uL
Interval 52.0 to 255.0
|
166 10^3 cells/uL
Interval 68.0 to 231.0
|
132 10^3 cells/uL
Interval 23.0 to 488.0
|
|
Baseline Prognostic Factors: Investigations
ANC
|
8.9 10^3 cells/uL
Interval 0.2 to 23.5
|
2.6 10^3 cells/uL
Interval 0.0 to 5.1
|
5.5 10^3 cells/uL
Interval 3.2 to 9.9
|
3 10^3 cells/uL
Interval 1.0 to 28.0
|
5 10^3 cells/uL
Interval 1.0 to 26.0
|
4 10^3 cells/uL
Interval 1.0 to 16.0
|
|
Baseline Prognostic Factors: Investigations
ALC
|
135.3 10^3 cells/uL
Interval 19.6 to 445.6
|
144.9 10^3 cells/uL
Interval 79.2 to 230.6
|
30.0 10^3 cells/uL
Interval 2.8 to 287.2
|
29 10^3 cells/uL
Interval 0.0 to 348.0
|
109 10^3 cells/uL
Interval 3.0 to 413.0
|
191 10^3 cells/uL
Interval 3.0 to 488.0
|
SECONDARY outcome
Timeframe: At baselineBeta-2-microglobulin (B2M)
Outcome measures
| Measure |
Phase 1b Cohort
n=3 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Phase 2 Relapsed/Refractory
n=3 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN1: Phase 2 Treatment Naïve
n=6 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN2: Phase 2 Treatment Naïve
n=25 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN1: Phase 2 Treatment Naïve
n=25 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN2: Phase 2 Treatment Naïve
n=25 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|---|---|---|
|
Baseline Prognostic Factor: Beta-2-microglobulin (B2M)
|
5.2 milligrams per liter
Interval 3.9 to 6.8
|
4.2 milligrams per liter
Interval 2.7 to 5.0
|
2.6 milligrams per liter
Interval 2.2 to 3.4
|
4 milligrams per liter
Interval 2.0 to 7.0
|
3 milligrams per liter
Interval 2.0 to 7.0
|
3 milligrams per liter
Interval 2.0 to 6.0
|
SECONDARY outcome
Timeframe: At baselinelactate dehydrogenase (LDH)
Outcome measures
| Measure |
Phase 1b Cohort
n=3 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Phase 2 Relapsed/Refractory
n=3 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN1: Phase 2 Treatment Naïve
n=6 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN2: Phase 2 Treatment Naïve
n=25 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN1: Phase 2 Treatment Naïve
n=25 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN2: Phase 2 Treatment Naïve
n=25 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|---|---|---|
|
Baseline Prognostic Factors: Lactate Dehydrogenase (LDH)
|
293 units per liter
Interval 219.0 to 371.0
|
301 units per liter
Interval 237.0 to 410.0
|
202 units per liter
Interval 155.0 to 899.0
|
223 units per liter
Interval 131.0 to 725.0
|
230 units per liter
Interval 98.0 to 710.0
|
280 units per liter
Interval 147.0 to 921.0
|
SECONDARY outcome
Timeframe: At baselinePopulation: The number of participants analyzed for each genetic factor represents the number of participants for which data was available for that genetic factor. The number of participants with High Hyperdiploid (HeH), was not a prespecified baseline measure so data was not collected for the phase 1b cohorts.
Outcome measures
| Measure |
Phase 1b Cohort
n=3 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Phase 2 Relapsed/Refractory
n=3 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN1: Phase 2 Treatment Naïve
n=6 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN2: Phase 2 Treatment Naïve
n=25 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN1: Phase 2 Treatment Naïve
n=25 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN2: Phase 2 Treatment Naïve
n=25 Participants
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|---|---|---|
|
Baseline Prognostic Factors: Genetic Factors
High Hyperdiploid (HeH)
|
—
|
—
|
—
|
19 participants
|
17 participants
|
19 participants
|
|
Baseline Prognostic Factors: Genetic Factors
Zap-70 methylated
|
0 participants
|
1 participants
|
4 participants
|
11 participants
|
8 participants
|
3 participants
|
|
Baseline Prognostic Factors: Genetic Factors
Complex karyotype
|
1 participants
|
1 participants
|
3 participants
|
8 participants
|
8 participants
|
11 participants
|
|
Baseline Prognostic Factors: Genetic Factors
del(17p)
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
3 participants
|
2 participants
|
|
Baseline Prognostic Factors: Genetic Factors
del(11q)
|
3 participants
|
1 participants
|
4 participants
|
9 participants
|
5 participants
|
7 participants
|
|
Baseline Prognostic Factors: Genetic Factors
trisomy 12
|
0 participants
|
0 participants
|
1 participants
|
4 participants
|
3 participants
|
3 participants
|
|
Baseline Prognostic Factors: Genetic Factors
del(13q)
|
2 participants
|
0 participants
|
2 participants
|
0 participants
|
5 participants
|
16 participants
|
Adverse Events
Phase 1b Cohort 100mg Venetoclax (GDC-0199)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Phase 1b Cohort 200mg Venetoclax (GDC-0199)
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase 1b Cohort 400mg Venetoclax (GDC-0199)
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase 2 Relapsed/Refractory
Serious events: 12 serious events
Other events: 25 other events
Deaths: 1 deaths
TN1: Phase 2 Treatment Naïve
Serious events: 7 serious events
Other events: 25 other events
Deaths: 1 deaths
TN2: Phase 2 Treatment Naïve
Serious events: 11 serious events
Other events: 25 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Phase 1b Cohort 100mg Venetoclax (GDC-0199)
n=3 participants at risk
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. GDC-0199 is administered through a dose ramp-up throughout course 3 with 20 mg administered in week 1, 50mg in week 2 and 100mg in week 3. The 100mg dose level continues through the rest of the treatment period. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Phase 1b Cohort 200mg Venetoclax (GDC-0199)
n=3 participants at risk
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. GDC-0199 is administered through a dose ramp-up throughout course 3 with 20 mg administered in week 1, 50mg in week 2, 100mg in week 3 and 200mg in week 4. The 200mg dose level continues through the rest of the treatment period. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Phase 1b Cohort 400mg Venetoclax (GDC-0199)
n=6 participants at risk
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. GDC-0199 is administered through a dose ramp-up throughout course 3 with 20 mg administered in week 1, 50mg in week 2, 100mg in week 3 and 200mg in week 4. The dose of GDC-0199 increases to 400mg starting week 1 of course 4. The 400mg dose level continues through the rest of the treatment period. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Phase 2 Relapsed/Refractory
n=25 participants at risk
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. GDC-0199 is administered through a dose ramp-up throughout course 3 with 20 mg administered in week 1, 50mg in week 2, 100mg in week 3 and 200mg in week 4. The dose of GDC-0199 increases to 400mg starting week 1 of course 4. The 400mg dose level continues through the rest of the treatment period. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN1: Phase 2 Treatment Naïve
n=25 participants at risk
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. GDC-0199 is administered through a dose ramp-up throughout course 3 with 20 mg administered in week 1, 50mg in week 2, 100mg in week 3 and 200mg in week 4. The dose of GDC-0199 increases to 400mg starting week 1 of course 4. The 400mg dose level continues through the rest of the treatment period. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN2: Phase 2 Treatment Naïve
n=25 participants at risk
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. GDC-0199 is administered through a dose ramp-up throughout course 3 with 20 mg administered in week 1, 50mg in week 2, 100mg in week 3 and 200mg in week 4. The dose of GDC-0199 increases to 400mg starting week 1 of course 4. The 400mg dose level continues through the rest of the treatment period. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
33.3%
1/3 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
General disorders
Flu like symptoms
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
33.3%
1/3 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
33.3%
1/3 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Infections and infestations
Infections and infestations - Other
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
33.3%
1/3 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
16.7%
1/6 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
12.0%
3/25 • Number of events 3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
33.3%
1/3 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
16.7%
1/6 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
8.0%
2/25 • Number of events 4 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Infections and infestations
Bronchial infection
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Cardiac disorders
Cardiac disorders - Other
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Cardiac disorders
Chest pain - cardiac
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
8.0%
2/25 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
General disorders
Fatigue
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
General disorders
Fever
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Nervous system disorders
Nervous system disorders - Other
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Infections and infestations
Skin infection
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
8.0%
2/25 • Number of events 3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
8.0%
2/25 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
8.0%
2/25 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
16.0%
4/25 • Number of events 7 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Injury, poisoning and procedural complications
Stroke
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
Other adverse events
| Measure |
Phase 1b Cohort 100mg Venetoclax (GDC-0199)
n=3 participants at risk
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. GDC-0199 is administered through a dose ramp-up throughout course 3 with 20 mg administered in week 1, 50mg in week 2 and 100mg in week 3. The 100mg dose level continues through the rest of the treatment period. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Phase 1b Cohort 200mg Venetoclax (GDC-0199)
n=3 participants at risk
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. GDC-0199 is administered through a dose ramp-up throughout course 3 with 20 mg administered in week 1, 50mg in week 2, 100mg in week 3 and 200mg in week 4. The 200mg dose level continues through the rest of the treatment period. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Phase 1b Cohort 400mg Venetoclax (GDC-0199)
n=6 participants at risk
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. GDC-0199 is administered through a dose ramp-up throughout course 3 with 20 mg administered in week 1, 50mg in week 2, 100mg in week 3 and 200mg in week 4. The dose of GDC-0199 increases to 400mg starting week 1 of course 4. The 400mg dose level continues through the rest of the treatment period. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Phase 2 Relapsed/Refractory
n=25 participants at risk
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. GDC-0199 is administered through a dose ramp-up throughout course 3 with 20 mg administered in week 1, 50mg in week 2, 100mg in week 3 and 200mg in week 4. The dose of GDC-0199 increases to 400mg starting week 1 of course 4. The 400mg dose level continues through the rest of the treatment period. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN1: Phase 2 Treatment Naïve
n=25 participants at risk
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. GDC-0199 is administered through a dose ramp-up throughout course 3 with 20 mg administered in week 1, 50mg in week 2, 100mg in week 3 and 200mg in week 4. The dose of GDC-0199 increases to 400mg starting week 1 of course 4. The 400mg dose level continues through the rest of the treatment period. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
TN2: Phase 2 Treatment Naïve
n=25 participants at risk
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. GDC-0199 is administered through a dose ramp-up throughout course 3 with 20 mg administered in week 1, 50mg in week 2, 100mg in week 3 and 200mg in week 4. The dose of GDC-0199 increases to 400mg starting week 1 of course 4. The 400mg dose level continues through the rest of the treatment period. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|---|---|---|
|
Immune system disorders
Allergic Reaction
|
33.3%
1/3 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
12.0%
3/25 • Number of events 5 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
8.0%
2/25 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
33.3%
1/3 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
33.3%
2/6 • Number of events 3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
44.0%
11/25 • Number of events 14 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
32.0%
8/25 • Number of events 9 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
8.0%
2/25 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
|
33.3%
1/3 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
100.0%
3/3 • Number of events 3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
50.0%
3/6 • Number of events 3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
52.0%
13/25 • Number of events 17 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
60.0%
15/25 • Number of events 24 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
12.0%
3/25 • Number of events 3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Gastrointestinal disorders
Abdominal pain
|
66.7%
2/3 • Number of events 5 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
33.3%
1/3 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
16.7%
1/6 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
28.0%
7/25 • Number of events 11 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
24.0%
6/25 • Number of events 7 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
16.0%
4/25 • Number of events 6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Investigations
Alanine Aminotransferase increased
|
66.7%
2/3 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
100.0%
3/3 • Number of events 4 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
66.7%
4/6 • Number of events 8 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
40.0%
10/25 • Number of events 23 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
32.0%
8/25 • Number of events 12 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
52.0%
13/25 • Number of events 23 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Investigations
Alkaline Phosphatase Increased
|
66.7%
2/3 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
12.0%
3/25 • Number of events 6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
24.0%
6/25 • Number of events 10 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
28.0%
7/25 • Number of events 15 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
12.0%
3/25 • Number of events 3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Blood and lymphatic system disorders
Anemia
|
66.7%
2/3 • Number of events 4 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
48.0%
12/25 • Number of events 20 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
40.0%
10/25 • Number of events 28 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
20.0%
5/25 • Number of events 16 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
33.3%
1/3 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
16.7%
1/6 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
40.0%
10/25 • Number of events 10 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
56.0%
14/25 • Number of events 21 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
48.0%
12/25 • Number of events 14 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
100.0%
3/3 • Number of events 4 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
33.3%
1/3 • Number of events 5 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
83.3%
5/6 • Number of events 10 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
52.0%
13/25 • Number of events 33 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
68.0%
17/25 • Number of events 37 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
36.0%
9/25 • Number of events 19 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
66.7%
2/3 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
33.3%
1/3 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
50.0%
3/6 • Number of events 5 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
20.0%
5/25 • Number of events 6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
40.0%
10/25 • Number of events 12 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Investigations
Aspartate Aminotransferase Increased
|
66.7%
2/3 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
100.0%
3/3 • Number of events 3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
50.0%
3/6 • Number of events 11 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
52.0%
13/25 • Number of events 35 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
48.0%
12/25 • Number of events 22 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
68.0%
17/25 • Number of events 40 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
8.0%
2/25 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
12.0%
3/25 • Number of events 4 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
12.0%
3/25 • Number of events 5 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
33.3%
1/3 • Number of events 3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
66.7%
2/3 • Number of events 3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
16.7%
1/6 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
40.0%
10/25 • Number of events 16 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
56.0%
14/25 • Number of events 22 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
24.0%
6/25 • Number of events 13 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Investigations
Blood Bilirubin Increased
|
66.7%
2/3 • Number of events 6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
16.7%
1/6 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
32.0%
8/25 • Number of events 24 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
48.0%
12/25 • Number of events 43 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
48.0%
12/25 • Number of events 54 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Gastrointestinal disorders
Bloating
|
33.3%
1/3 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
20.0%
5/25 • Number of events 8 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Eye disorders
Blurred Vision
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
66.7%
4/6 • Number of events 4 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
24.0%
6/25 • Number of events 8 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
40.0%
10/25 • Number of events 11 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
12.0%
3/25 • Number of events 3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
33.3%
2/6 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
12.0%
3/25 • Number of events 4 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
16.0%
4/25 • Number of events 5 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
12.0%
3/25 • Number of events 3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Infections and infestations
Bronchial Infection
|
33.3%
1/3 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
66.7%
2/3 • Number of events 4 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
20.0%
5/25 • Number of events 7 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
12.0%
3/25 • Number of events 3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
8.0%
2/25 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Injury, poisoning and procedural complications
Bruising
|
100.0%
3/3 • Number of events 3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
100.0%
3/3 • Number of events 6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
100.0%
6/6 • Number of events 12 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
80.0%
20/25 • Number of events 34 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
76.0%
19/25 • Number of events 33 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
76.0%
19/25 • Number of events 30 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Skin and subcutaneous tissue disorders
Bullous Dermatitis
|
66.7%
2/3 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
33.3%
1/3 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
8.0%
2/25 • Number of events 3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Eye disorders
Cataract
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
12.0%
3/25 • Number of events 3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
16.0%
4/25 • Number of events 5 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
General disorders
Non-cardiac Chest Pain
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
16.7%
1/6 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
32.0%
8/25 • Number of events 11 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
20.0%
5/25 • Number of events 5 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
20.0%
5/25 • Number of events 9 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Cardiac disorders
Chest pain - Cardiac
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
16.7%
1/6 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
16.0%
4/25 • Number of events 4 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
8.0%
2/25 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
General disorders
Chills
|
33.3%
1/3 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
33.3%
1/3 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
40.0%
10/25 • Number of events 14 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
52.0%
13/25 • Number of events 20 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
36.0%
9/25 • Number of events 10 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Investigations
High Cholesterol
|
33.3%
1/3 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
16.7%
1/6 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
28.0%
7/25 • Number of events 7 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
16.0%
4/25 • Number of events 4 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Renal and urinary disorders
Chronic Kidney Disease
|
33.3%
1/3 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
16.7%
1/6 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
16.0%
4/25 • Number of events 4 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
16.7%
1/6 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
12.0%
3/25 • Number of events 3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
8.0%
2/25 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Eye disorders
Conjunctivitis
|
33.3%
1/3 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
66.7%
2/3 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
50.0%
3/6 • Number of events 4 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
48.0%
12/25 • Number of events 24 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
64.0%
16/25 • Number of events 32 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
32.0%
8/25 • Number of events 18 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
66.7%
2/3 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
66.7%
2/3 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
33.3%
2/6 • Number of events 4 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
52.0%
13/25 • Number of events 32 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
64.0%
16/25 • Number of events 26 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
52.0%
13/25 • Number of events 21 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Investigations
Creatinine Increased
|
66.7%
2/3 • Number of events 7 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
66.7%
2/3 • Number of events 7 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
16.7%
1/6 • Number of events 8 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
44.0%
11/25 • Number of events 32 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
36.0%
9/25 • Number of events 27 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
48.0%
12/25 • Number of events 25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Gastrointestinal disorders
Dental Caries
|
33.3%
1/3 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
16.7%
1/6 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
28.0%
7/25 • Number of events 9 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
16.7%
1/6 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
24.0%
6/25 • Number of events 9 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
24.0%
6/25 • Number of events 6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Gastrointestinal disorders
Diarrhea
|
66.7%
2/3 • Number of events 4 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
66.7%
2/3 • Number of events 5 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
100.0%
6/6 • Number of events 16 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
76.0%
19/25 • Number of events 46 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
68.0%
17/25 • Number of events 44 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
96.0%
24/25 • Number of events 63 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Nervous system disorders
Dizziness
|
33.3%
1/3 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
33.3%
1/3 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
83.3%
5/6 • Number of events 6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
32.0%
8/25 • Number of events 11 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
48.0%
12/25 • Number of events 19 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
48.0%
12/25 • Number of events 16 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Eye disorders
Dry Eyes
|
33.3%
1/3 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
16.7%
1/6 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
12.0%
3/25 • Number of events 5 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
16.0%
4/25 • Number of events 4 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
24.0%
6/25 • Number of events 6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Gastrointestinal disorders
Dry Mouth
|
33.3%
1/3 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
33.3%
2/6 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
12.0%
3/25 • Number of events 3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
33.3%
1/3 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
33.3%
2/6 • Number of events 3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
32.0%
8/25 • Number of events 10 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
32.0%
8/25 • Number of events 9 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
28.0%
7/25 • Number of events 7 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
33.3%
1/3 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
16.7%
1/6 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
12.0%
3/25 • Number of events 5 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
8.0%
2/25 • Number of events 6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
24.0%
6/25 • Number of events 7 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Gastrointestinal disorders
Dyspepsia
|
33.3%
1/3 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
66.7%
2/3 • Number of events 4 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
66.7%
4/6 • Number of events 5 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
64.0%
16/25 • Number of events 29 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
84.0%
21/25 • Number of events 44 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
32.0%
8/25 • Number of events 14 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
12.0%
3/25 • Number of events 3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
12.0%
3/25 • Number of events 3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
1/3 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
33.3%
1/3 • Number of events 5 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
66.7%
4/6 • Number of events 11 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
60.0%
15/25 • Number of events 23 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
68.0%
17/25 • Number of events 25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
36.0%
9/25 • Number of events 14 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Ear and labyrinth disorders
Ear Pain
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
8.0%
2/25 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
8.0%
2/25 • Number of events 5 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
16.0%
4/25 • Number of events 4 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
83.3%
5/6 • Number of events 11 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
36.0%
9/25 • Number of events 17 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
44.0%
11/25 • Number of events 21 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
8.0%
2/25 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
33.3%
2/6 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
28.0%
7/25 • Number of events 10 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
32.0%
8/25 • Number of events 10 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
12.0%
3/25 • Number of events 5 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
General disorders
Fatigue
|
100.0%
3/3 • Number of events 4 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
66.7%
2/3 • Number of events 19 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
100.0%
6/6 • Number of events 24 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
84.0%
21/25 • Number of events 66 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
92.0%
23/25 • Number of events 76 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
68.0%
17/25 • Number of events 39 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
General disorders
Fever
|
66.7%
2/3 • Number of events 3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
33.3%
2/6 • Number of events 3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
40.0%
10/25 • Number of events 15 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
24.0%
6/25 • Number of events 17 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
28.0%
7/25 • Number of events 10 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
66.7%
2/3 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
16.7%
1/6 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
8.0%
2/25 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Eye disorders
Floaters
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
16.7%
1/6 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
8.0%
2/25 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
8.0%
2/25 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
General disorders
Flu like Symptoms
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
66.7%
2/3 • Number of events 5 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
66.7%
4/6 • Number of events 5 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
24.0%
6/25 • Number of events 6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
16.0%
4/25 • Number of events 6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
44.0%
11/25 • Number of events 21 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Vascular disorders
Flushing
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
16.7%
1/6 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
8.0%
2/25 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
8.0%
2/25 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
33.3%
1/3 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
50.0%
3/6 • Number of events 4 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
8.0%
2/25 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
12.0%
3/25 • Number of events 3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Nervous system disorders
Headache
|
66.7%
2/3 • Number of events 5 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
66.7%
2/3 • Number of events 6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
83.3%
5/6 • Number of events 6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
56.0%
14/25 • Number of events 35 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
64.0%
16/25 • Number of events 27 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
60.0%
15/25 • Number of events 23 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Ear and labyrinth disorders
Hearing Impaired
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
8.0%
2/25 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Renal and urinary disorders
Hematuria
|
33.3%
1/3 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
20.0%
5/25 • Number of events 5 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
28.0%
7/25 • Number of events 8 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
8.0%
2/25 • Number of events 3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
33.3%
1/3 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
16.7%
1/6 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
8.0%
2/25 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Vascular disorders
Hot Flashes
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
24.0%
6/25 • Number of events 6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
12.0%
3/25 • Number of events 3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
100.0%
3/3 • Number of events 5 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
83.3%
5/6 • Number of events 7 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
64.0%
16/25 • Number of events 53 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
72.0%
18/25 • Number of events 40 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
56.0%
14/25 • Number of events 31 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
100.0%
3/3 • Number of events 4 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
100.0%
3/3 • Number of events 7 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
33.3%
2/6 • Number of events 4 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
40.0%
10/25 • Number of events 17 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
48.0%
12/25 • Number of events 24 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
28.0%
7/25 • Number of events 12 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
33.3%
1/3 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
33.3%
1/3 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
12.0%
3/25 • Number of events 6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
20.0%
5/25 • Number of events 7 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
33.3%
1/3 • Number of events 4 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
66.7%
2/3 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
16.7%
1/6 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
36.0%
9/25 • Number of events 13 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
24.0%
6/25 • Number of events 13 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
12.0%
3/25 • Number of events 3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Vascular disorders
Hypertension
|
100.0%
3/3 • Number of events 17 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
100.0%
3/3 • Number of events 26 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
100.0%
6/6 • Number of events 52 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
100.0%
25/25 • Number of events 225 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
100.0%
25/25 • Number of events 207 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
88.0%
22/25 • Number of events 125 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
100.0%
3/3 • Number of events 6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
66.7%
2/3 • Number of events 5 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
83.3%
5/6 • Number of events 20 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
72.0%
18/25 • Number of events 55 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
60.0%
15/25 • Number of events 37 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
48.0%
12/25 • Number of events 28 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
33.3%
1/3 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
33.3%
2/6 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
32.0%
8/25 • Number of events 15 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
52.0%
13/25 • Number of events 53 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
16.0%
4/25 • Number of events 9 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
100.0%
3/3 • Number of events 3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
100.0%
3/3 • Number of events 17 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
83.3%
5/6 • Number of events 11 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
84.0%
21/25 • Number of events 74 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
80.0%
20/25 • Number of events 98 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
72.0%
18/25 • Number of events 56 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
36.0%
9/25 • Number of events 22 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
28.0%
7/25 • Number of events 21 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
28.0%
7/25 • Number of events 8 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
66.7%
2/3 • Number of events 3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
33.3%
1/3 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
40.0%
10/25 • Number of events 28 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
48.0%
12/25 • Number of events 40 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
40.0%
10/25 • Number of events 24 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
33.3%
1/3 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
20.0%
5/25 • Number of events 11 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
20.0%
5/25 • Number of events 14 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
24.0%
6/25 • Number of events 12 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
33.3%
1/3 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
24.0%
6/25 • Number of events 19 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
24.0%
6/25 • Number of events 16 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
20.0%
5/25 • Number of events 18 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
33.3%
1/3 • Number of events 5 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
66.7%
2/3 • Number of events 5 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
66.7%
4/6 • Number of events 13 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
28.0%
7/25 • Number of events 19 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
24.0%
6/25 • Number of events 11 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
24.0%
6/25 • Number of events 14 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
16.7%
1/6 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
12.0%
3/25 • Number of events 3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction
|
100.0%
3/3 • Number of events 3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
100.0%
3/3 • Number of events 6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
66.7%
4/6 • Number of events 4 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
68.0%
17/25 • Number of events 21 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
80.0%
20/25 • Number of events 25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
84.0%
21/25 • Number of events 25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Psychiatric disorders
Insomnia
|
33.3%
1/3 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
66.7%
2/3 • Number of events 5 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
66.7%
4/6 • Number of events 6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
32.0%
8/25 • Number of events 11 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
64.0%
16/25 • Number of events 23 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
40.0%
10/25 • Number of events 13 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Musculoskeletal and connective tissue disorders
Joint Range of Motion Decreased
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
8.0%
2/25 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
33.3%
1/3 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
8.0%
2/25 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
12.0%
3/25 • Number of events 3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
8.0%
2/25 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Infections and infestations
Lung Infection
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
33.3%
1/3 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
16.7%
1/6 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
8.0%
2/25 • Number of events 4 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
16.0%
4/25 • Number of events 5 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
16.0%
4/25 • Number of events 8 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Blood and lymphatic system disorders
Lymph Node Pain
|
33.3%
1/3 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
33.3%
1/3 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
12.0%
3/25 • Number of events 3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
20.0%
5/25 • Number of events 5 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Investigations
Lymphocyte Count Decreased
|
100.0%
3/3 • Number of events 24 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
100.0%
3/3 • Number of events 29 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
83.3%
5/6 • Number of events 30 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
92.0%
23/25 • Number of events 170 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
88.0%
22/25 • Number of events 162 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
100.0%
25/25 • Number of events 172 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Investigations
Lymphocyte Count Increased
|
66.7%
2/3 • Number of events 5 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
100.0%
3/3 • Number of events 3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
16.7%
1/6 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
52.0%
13/25 • Number of events 34 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
60.0%
15/25 • Number of events 22 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
68.0%
17/25 • Number of events 31 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
General disorders
Malaise
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
12.0%
3/25 • Number of events 5 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
16.0%
4/25 • Number of events 4 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Gastrointestinal disorders
Mucositis Oral
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
66.7%
2/3 • Number of events 5 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
33.3%
2/6 • Number of events 4 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
52.0%
13/25 • Number of events 25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
80.0%
20/25 • Number of events 42 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
60.0%
15/25 • Number of events 33 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
66.7%
2/3 • Number of events 3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
33.3%
1/3 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
100.0%
6/6 • Number of events 13 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
76.0%
19/25 • Number of events 41 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
72.0%
18/25 • Number of events 40 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
60.0%
15/25 • Number of events 29 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Skin and subcutaneous tissue disorders
Nail Loss
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
33.3%
1/3 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
16.7%
1/6 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
28.0%
7/25 • Number of events 8 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
24.0%
6/25 • Number of events 6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
66.7%
2/3 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
66.7%
2/3 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
50.0%
3/6 • Number of events 3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
36.0%
9/25 • Number of events 12 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
24.0%
6/25 • Number of events 10 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
28.0%
7/25 • Number of events 10 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
66.7%
2/3 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
66.7%
4/6 • Number of events 8 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
52.0%
13/25 • Number of events 32 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
72.0%
18/25 • Number of events 41 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
68.0%
17/25 • Number of events 34 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
33.3%
1/3 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
33.3%
1/3 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
16.0%
4/25 • Number of events 5 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
8.0%
2/25 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Investigations
Neutrophil Count Decreased
|
100.0%
3/3 • Number of events 18 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
100.0%
3/3 • Number of events 34 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
100.0%
6/6 • Number of events 24 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
96.0%
24/25 • Number of events 229 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
92.0%
23/25 • Number of events 169 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
96.0%
24/25 • Number of events 169 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Gastrointestinal disorders
Oral Pain
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
16.7%
1/6 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
20.0%
5/25 • Number of events 7 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Infections and infestations
Otitis Media
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
8.0%
2/25 • Number of events 3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
12.0%
3/25 • Number of events 3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
16.0%
4/25 • Number of events 5 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
General disorders
Pain
|
66.7%
2/3 • Number of events 4 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
50.0%
3/6 • Number of events 6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
32.0%
8/25 • Number of events 9 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
24.0%
6/25 • Number of events 8 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
16.0%
4/25 • Number of events 6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
16.0%
4/25 • Number of events 7 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
16.0%
4/25 • Number of events 4 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
24.0%
6/25 • Number of events 7 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Nervous system disorders
Paresthesia
|
33.3%
1/3 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
66.7%
2/3 • Number of events 3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
33.3%
2/6 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
40.0%
10/25 • Number of events 15 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
52.0%
13/25 • Number of events 21 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
44.0%
11/25 • Number of events 19 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
33.3%
1/3 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
50.0%
3/6 • Number of events 3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
16.0%
4/25 • Number of events 4 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
8.0%
2/25 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Investigations
Platelet Count Decreased
|
66.7%
2/3 • Number of events 21 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
100.0%
3/3 • Number of events 12 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
83.3%
5/6 • Number of events 58 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
88.0%
22/25 • Number of events 177 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
96.0%
24/25 • Number of events 175 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
88.0%
22/25 • Number of events 103 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal Drip
|
33.3%
1/3 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
16.7%
1/6 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
28.0%
7/25 • Number of events 12 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
24.0%
6/25 • Number of events 7 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
24.0%
6/25 • Number of events 7 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
20.0%
5/25 • Number of events 6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
16.0%
4/25 • Number of events 6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
16.0%
4/25 • Number of events 4 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
1/3 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
33.3%
1/3 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
12.0%
3/25 • Number of events 3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
20.0%
5/25 • Number of events 7 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Skin and subcutaneous tissue disorders
Rash Acneiform
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
12.0%
3/25 • Number of events 3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
16.0%
4/25 • Number of events 5 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
8.0%
2/25 • Number of events 3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-papular
|
33.3%
1/3 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
33.3%
1/3 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
33.3%
2/6 • Number of events 4 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
36.0%
9/25 • Number of events 23 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
72.0%
18/25 • Number of events 33 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
32.0%
8/25 • Number of events 12 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Cardiac disorders
Sinus Bradycardia
|
33.3%
1/3 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
33.3%
2/6 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
52.0%
13/25 • Number of events 36 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
44.0%
11/25 • Number of events 20 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
44.0%
11/25 • Number of events 29 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Disorder
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
16.0%
4/25 • Number of events 6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Pain
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
12.0%
3/25 • Number of events 4 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
8.0%
2/25 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Cardiac disorders
Sinus Tachycardia
|
33.3%
1/3 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
24.0%
6/25 • Number of events 9 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
16.0%
4/25 • Number of events 5 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
24.0%
6/25 • Number of events 10 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Infections and infestations
Sinusitis
|
66.7%
2/3 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
66.7%
2/3 • Number of events 4 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
33.3%
2/6 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
60.0%
15/25 • Number of events 35 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
44.0%
11/25 • Number of events 25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
36.0%
9/25 • Number of events 15 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Infections and infestations
Skin Infection
|
33.3%
1/3 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
66.7%
4/6 • Number of events 8 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
20.0%
5/25 • Number of events 13 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
20.0%
5/25 • Number of events 11 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
12.0%
3/25 • Number of events 6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep Apnea
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
33.3%
1/3 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
33.3%
2/6 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
8.0%
2/25 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
33.3%
1/3 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
16.7%
1/6 • Number of events 3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
36.0%
9/25 • Number of events 12 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
48.0%
12/25 • Number of events 17 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
32.0%
8/25 • Number of events 11 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
8.0%
2/25 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
8.0%
2/25 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Reproductive system and breast disorders
Testicular Pain
|
33.3%
1/3 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
16.7%
1/6 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
8.0%
2/25 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
20.0%
5/25 • Number of events 7 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
12.0%
3/25 • Number of events 4 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
8.0%
2/25 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Gastrointestinal disorders
Toothache
|
33.3%
1/3 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
16.7%
1/6 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
12.0%
3/25 • Number of events 5 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
12.0%
3/25 • Number of events 3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
16.0%
4/25 • Number of events 4 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Nervous system disorders
Tremor
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
16.7%
1/6 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
12.0%
3/25 • Number of events 4 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Infections and infestations
Upper Respiratory Infection
|
66.7%
2/3 • Number of events 5 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
100.0%
3/3 • Number of events 5 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
66.7%
4/6 • Number of events 8 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
48.0%
12/25 • Number of events 30 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
60.0%
15/25 • Number of events 28 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
32.0%
8/25 • Number of events 11 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Renal and urinary disorders
Urinary Frequency
|
33.3%
1/3 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
33.3%
1/3 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
20.0%
5/25 • Number of events 5 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
32.0%
8/25 • Number of events 8 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
12.0%
3/25 • Number of events 5 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
16.7%
1/6 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
12.0%
3/25 • Number of events 6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
40.0%
10/25 • Number of events 20 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
8.0%
2/25 • Number of events 3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
66.7%
2/3 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
16.7%
1/6 • Number of events 3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
36.0%
9/25 • Number of events 19 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
32.0%
8/25 • Number of events 10 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
32.0%
8/25 • Number of events 12 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Investigations
White Blood Cell Decreased
|
100.0%
3/3 • Number of events 19 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
100.0%
3/3 • Number of events 34 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
83.3%
5/6 • Number of events 24 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
96.0%
24/25 • Number of events 231 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
92.0%
23/25 • Number of events 184 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
96.0%
24/25 • Number of events 186 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Investigations
Weight Gain
|
100.0%
3/3 • Number of events 7 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
100.0%
3/3 • Number of events 13 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
50.0%
3/6 • Number of events 6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
68.0%
17/25 • Number of events 42 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
80.0%
20/25 • Number of events 57 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
72.0%
18/25 • Number of events 51 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Investigations
Weight Loss
|
33.3%
1/3 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
33.3%
1/3 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
50.0%
3/6 • Number of events 10 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
32.0%
8/25 • Number of events 11 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
24.0%
6/25 • Number of events 10 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
28.0%
7/25 • Number of events 8 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
66.7%
2/3 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
16.7%
1/6 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other
|
33.3%
1/3 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
33.3%
1/3 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
8.0%
2/25 • Number of events 3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other
|
33.3%
1/3 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
24.0%
6/25 • Number of events 6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
8.0%
2/25 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
16.0%
4/25 • Number of events 5 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Eye disorders
Eye disorders - Other
|
33.3%
1/3 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
33.3%
1/3 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
12.0%
3/25 • Number of events 6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
12.0%
3/25 • Number of events 3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
32.0%
8/25 • Number of events 12 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
33.3%
1/3 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
8.0%
2/25 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
66.7%
2/3 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
33.3%
2/6 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
44.0%
11/25 • Number of events 14 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
36.0%
9/25 • Number of events 18 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
28.0%
7/25 • Number of events 8 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Infections and infestations
Gum infection
|
33.3%
1/3 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
8.0%
2/25 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other
|
33.3%
1/3 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
33.3%
1/3 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
83.3%
5/6 • Number of events 11 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
24.0%
6/25 • Number of events 9 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
40.0%
10/25 • Number of events 17 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
32.0%
8/25 • Number of events 10 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other
|
66.7%
2/3 • Number of events 5 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
66.7%
2/3 • Number of events 4 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
50.0%
3/6 • Number of events 6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
28.0%
7/25 • Number of events 17 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
24.0%
6/25 • Number of events 8 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
20.0%
5/25 • Number of events 7 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other
|
66.7%
2/3 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
66.7%
2/3 • Number of events 3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
50.0%
3/6 • Number of events 3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
60.0%
15/25 • Number of events 29 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
44.0%
11/25 • Number of events 28 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
64.0%
16/25 • Number of events 37 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
33.3%
1/3 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
33.3%
1/3 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
33.3%
2/6 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
40.0%
10/25 • Number of events 22 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
36.0%
9/25 • Number of events 13 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
28.0%
7/25 • Number of events 9 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
66.7%
2/3 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
12.0%
3/25 • Number of events 3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other
|
66.7%
2/3 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
100.0%
3/3 • Number of events 4 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
33.3%
1/3 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
83.3%
5/6 • Number of events 12 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
40.0%
10/25 • Number of events 24 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
56.0%
14/25 • Number of events 23 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
48.0%
12/25 • Number of events 29 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Surgical and medical procedures
Surgical and medical procedures - Other
|
33.3%
1/3 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Renal and urinary disorders
Urinary retention
|
33.3%
1/3 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
12.0%
3/25 • Number of events 3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Vascular disorders
Vascular disorders - Other
|
66.7%
2/3 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
33.3%
1/3 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Nervous system disorders
Cognitive disturbance
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
33.3%
1/3 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Infections and infestations
Eye infection
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
33.3%
1/3 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
General disorders
General disorders and administration site conditions - Other
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
33.3%
1/3 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
33.3%
1/3 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Infections and infestations
Infections and infestations - Other
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
33.3%
1/3 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
33.3%
2/6 • Number of events 3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
44.0%
11/25 • Number of events 17 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
48.0%
12/25 • Number of events 28 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
64.0%
16/25 • Number of events 35 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
33.3%
1/3 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
33.3%
1/3 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
33.3%
2/6 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Eye disorders
Flashing lights
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
16.7%
1/6 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
33.3%
1/3 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
33.3%
1/3 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
16.0%
4/25 • Number of events 5 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
33.3%
1/3 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
8.0%
2/25 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Infections and infestations
Rhinitis infective
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
33.3%
1/3 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Renal and urinary disorders
Urinary urgency
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
33.3%
1/3 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Gastrointestinal disorders
Anal hemorrhage
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
16.7%
1/6 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Renal and urinary disorders
Bladder spasm
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
16.7%
1/6 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Cardiac disorders
Cardiac disorders - Other
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
16.7%
1/6 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
8.0%
2/25 • Number of events 3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
12.0%
3/25 • Number of events 4 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Dysarthria
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
16.7%
1/6 • Number of events 3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
General disorders
Edema cerebral
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
16.7%
1/6 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
General disorders
Edema face
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
16.7%
1/6 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
General disorders
Edema limbs
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
33.3%
2/6 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
28.0%
7/25 • Number of events 9 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
32.0%
8/25 • Number of events 8 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
24.0%
6/25 • Number of events 10 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
16.7%
1/6 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
8.0%
2/25 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Vascular disorders
Hematoma
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
16.7%
1/6 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
8.0%
2/25 • Number of events 4 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Psychiatric disorders
Hypersomnia
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
16.7%
1/6 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Investigations
Investigations - Other
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
16.7%
1/6 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
General disorders
Localized edema
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
16.7%
1/6 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
48.0%
12/25 • Number of events 18 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
40.0%
10/25 • Number of events 15 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
32.0%
8/25 • Number of events 8 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
16.7%
1/6 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
8.0%
2/25 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
General disorders
Periorbital edema
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
16.7%
1/6 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
16.7%
1/6 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
16.7%
1/6 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
16.7%
1/6 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
16.7%
1/6 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
16.7%
1/6 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
8.0%
2/25 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
16.7%
1/6 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
8.0%
2/25 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
8.0%
2/25 • Number of events 3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
12.0%
3/25 • Number of events 4 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Infections and infestations
Nail infection
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
8.0%
2/25 • Number of events 3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
12.0%
3/25 • Number of events 3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Gastrointestinal disorders
Oral hemorrhage
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
8.0%
2/25 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
8.0%
2/25 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
8.0%
2/25 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
12.0%
3/25 • Number of events 3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
12.0%
3/25 • Number of events 3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Eye disorders
Watering eyes
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
8.0%
2/25 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
12.0%
3/25 • Number of events 3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
12.0%
3/25 • Number of events 4 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
8.0%
2/25 • Number of events 3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
8.0%
2/25 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
8.0%
2/25 • Number of events 3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
8.0%
2/25 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
8.0%
2/25 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
8.0%
2/25 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
8.0%
2/25 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Investigations
INR increased
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
8.0%
2/25 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Nervous system disorders
Nervous system disorders - Other
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
8.0%
2/25 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/25 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 1 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
8.0%
2/25 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
|
Skin and subcutaneous tissue disorders
Paronychia
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/3 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
0.00%
0/6 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 5 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
4.0%
1/25 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
8.0%
2/25 • Number of events 2 • Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
|
Additional Information
Dr. Kerry Rogers
The Ohio State University Comprehensive Cancer Center
Phone: 614-293-3873
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place