Trial Outcomes & Findings for PD 0332991 and Cetuximab in Patients With Incurable SCCHN (NCT NCT02101034)
NCT ID: NCT02101034
Last Updated: 2023-12-21
Results Overview
MTD is the dose level (DL) immediately below the DL at which 2 patients of a cohort experience dose limiting toxicity (DLT) in the 1st cycle (DLTs) Hematologic DLT is any of the below that occur during the 1st cycle that are possibly, probably, or definitely related to the treatment grade 4 neutropenia ≥7 days grade 4 infection with grade 3/4 neutropenia grade 4 thrombocytopenia with life-threatening bleeding treatment held for \>14 days due to hematologic toxicity febrile neutropenia with temperature \>=38.5°C Non-hematologic DLT is any possibly, probably, or definitely related grade 3 or 4 non-hematologic toxicity that occurs during the 1st except for suboptimally treated grade 3 or 4 nausea, vomiting, diarrhea, anorexia, or lymphopenia grade 3 metabolic abnormalities (limited to potassium, magnesium, and calcium) any hypersensitivity/infusion reaction or acneiform rash due to cetuximab treatment held for \>14 days due to non-hematologic toxicity
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
96 participants
Primary outcome timeframe
6 months (estimated completion of Phase I)
Results posted on
2023-12-21
Participant Flow
Participant milestones
| Measure |
Phase I: Dose Level 1
PD 0332991 100 mg per day will be administered on Days 1 through 21 of each 28 day cycle.
Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.
|
Phase I: Dose Level 2
PD 0332991 125 mg per day will be administered on Days 1 through 21 of each 28 day cycle.
Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.
|
Phase II Arm 1: Platin-Resistant HPV-Unrelated SCCHN
PD 0332991 125 mg per day will be administered on Days 1 through 21 of each 28 day cycle.
Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.
|
Phase II Arm 2: Cetuximab-Resistant HPV-Unrelated SCCHN
PD 0332991 125 mg per day will be administered on Days 1 through 21 of each 28 day cycle.
Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.
|
Phase II Arm 3:
PD 0332991 125 mg per day will be administered on Days 1 through 21 of each 28 day cycle.
Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
6
|
31
|
32
|
24
|
|
Overall Study
COMPLETED
|
3
|
6
|
30
|
32
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Phase I: Dose Level 1
PD 0332991 100 mg per day will be administered on Days 1 through 21 of each 28 day cycle.
Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.
|
Phase I: Dose Level 2
PD 0332991 125 mg per day will be administered on Days 1 through 21 of each 28 day cycle.
Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.
|
Phase II Arm 1: Platin-Resistant HPV-Unrelated SCCHN
PD 0332991 125 mg per day will be administered on Days 1 through 21 of each 28 day cycle.
Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.
|
Phase II Arm 2: Cetuximab-Resistant HPV-Unrelated SCCHN
PD 0332991 125 mg per day will be administered on Days 1 through 21 of each 28 day cycle.
Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.
|
Phase II Arm 3:
PD 0332991 125 mg per day will be administered on Days 1 through 21 of each 28 day cycle.
Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.
|
|---|---|---|---|---|---|
|
Overall Study
Enrolled but did not start treatment
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
PD 0332991 and Cetuximab in Patients With Incurable SCCHN
Baseline characteristics by cohort
| Measure |
Phase I: Dose Level 1
n=3 Participants
PD 0332991 100 mg per day will be administered on Days 1 through 21 of each 28 day cycle.
Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.
|
Phase I: Dose Level 2
n=6 Participants
PD 0332991 125 mg per day will be administered on Days 1 through 21 of each 28 day cycle.
Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.
|
Phase II Arm 1: Platin-Resistant HPV-Unrelated SCCHN
n=31 Participants
PD 0332991 125 mg per day will be administered on Days 1 through 21 of each 28 day cycle.
Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.
|
Phase II Arm 2: Cetuximab-Resistant HPV-Unrelated SCCHN
n=32 Participants
PD 0332991 125 mg per day will be administered on Days 1 through 21 of each 28 day cycle.
Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.
|
Phase II Arm 3:
n=24 Participants
PD 0332991 125 mg per day will be administered on Days 1 through 21 of each 28 day cycle.
Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.
|
Total
n=96 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
62 years
n=93 Participants
|
61 years
n=4 Participants
|
64 years
n=27 Participants
|
64 years
n=483 Participants
|
66 years
n=36 Participants
|
63 years
n=10 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
11 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
22 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
21 Participants
n=483 Participants
|
22 Participants
n=36 Participants
|
74 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
30 Participants
n=27 Participants
|
30 Participants
n=483 Participants
|
23 Participants
n=36 Participants
|
92 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
16 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
24 Participants
n=483 Participants
|
24 Participants
n=36 Participants
|
77 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=93 Participants
|
6 participants
n=4 Participants
|
31 participants
n=27 Participants
|
32 participants
n=483 Participants
|
24 participants
n=36 Participants
|
96 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: 6 months (estimated completion of Phase I)Population: Only Phase I participants were evaluable for this outcome measure.
MTD is the dose level (DL) immediately below the DL at which 2 patients of a cohort experience dose limiting toxicity (DLT) in the 1st cycle (DLTs) Hematologic DLT is any of the below that occur during the 1st cycle that are possibly, probably, or definitely related to the treatment grade 4 neutropenia ≥7 days grade 4 infection with grade 3/4 neutropenia grade 4 thrombocytopenia with life-threatening bleeding treatment held for \>14 days due to hematologic toxicity febrile neutropenia with temperature \>=38.5°C Non-hematologic DLT is any possibly, probably, or definitely related grade 3 or 4 non-hematologic toxicity that occurs during the 1st except for suboptimally treated grade 3 or 4 nausea, vomiting, diarrhea, anorexia, or lymphopenia grade 3 metabolic abnormalities (limited to potassium, magnesium, and calcium) any hypersensitivity/infusion reaction or acneiform rash due to cetuximab treatment held for \>14 days due to non-hematologic toxicity
Outcome measures
| Measure |
Phase I: Dose Level 1 and Dose Level 2
n=9 Participants
* PD 0332991 will be administered on Days 1 through 21 of each 28 day cycle.
* Dose Level 1 PD 0332991 100 mg per day
* Dose Level 2 PD 0332991 125 mg per day
Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.
|
Phase II Arm 1: Platin-Resistant HPV-Unrelated SCCHN
PD 0332991 125 mg per day will be administered on Days 1 through 21 of each 28 day cycle.
Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.
|
Phase II Arm 2: Cetuximab-Resistant HPV-Unrelated SCCHN
PD 0332991 125 mg per day will be administered on Days 1 through 21 of each 28 day cycle.
Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.
|
Phase II Arm 3:
PD 0332991 125 mg per day will be administered on Days 1 through 21 of each 28 day cycle.
Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.
|
Phase II Arm 3:
PD 0332991 125 mg per day will be administered on Days 1 through 21 of each 28 day cycle.
Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.
|
|---|---|---|---|---|---|
|
Phase I - Maximum Tolerated Dose (MTD)
|
NA mg
None of the nine participants enrolled in the Phase I portion of the study experienced a dose-limiting toxicity. A MTD of palbociclib was not reached.
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: End of treatment (estimated to be 12 months)Population: Phase I participants were excluded from this outcome measure. 2 participants in Phase II Arm 1 were not evaluable due to early death and inability to measure the target lesion on the post-treatment non-contrast CT scan. 5 participants in Phase II Arm 2 were not evaluable due to comorbidity-related death (N=2), patient withdrawal (N=2), and non-treatment related adverse event (N=1).
Tumor measurements will be collected at baseline, end of every even numbered cycles, and end of treatment. Measured by overall response rate (ORR=CR+PR) defined by RECIST criteria Best overall response is the best response recorded from the start of treatment until disease progression/recurrence Complete Response (CR) is defined as disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\<10 mm short axis). Partial Response (PR) is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters
Outcome measures
| Measure |
Phase I: Dose Level 1 and Dose Level 2
* PD 0332991 will be administered on Days 1 through 21 of each 28 day cycle.
* Dose Level 1 PD 0332991 100 mg per day
* Dose Level 2 PD 0332991 125 mg per day
Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.
|
Phase II Arm 1: Platin-Resistant HPV-Unrelated SCCHN
PD 0332991 125 mg per day will be administered on Days 1 through 21 of each 28 day cycle.
Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.
|
Phase II Arm 2: Cetuximab-Resistant HPV-Unrelated SCCHN
n=28 Participants
PD 0332991 125 mg per day will be administered on Days 1 through 21 of each 28 day cycle.
Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.
|
Phase II Arm 3:
n=27 Participants
PD 0332991 125 mg per day will be administered on Days 1 through 21 of each 28 day cycle.
Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.
|
Phase II Arm 3:
n=24 Participants
PD 0332991 125 mg per day will be administered on Days 1 through 21 of each 28 day cycle.
Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.
|
|---|---|---|---|---|---|
|
Phase II: Efficacy as Measured by Overall Response Rate
|
—
|
—
|
11 Participants
|
5 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 30 days following completion of treatment (estimated to be 13 months)Assessed by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Outcome measures
| Measure |
Phase I: Dose Level 1 and Dose Level 2
n=3 Participants
* PD 0332991 will be administered on Days 1 through 21 of each 28 day cycle.
* Dose Level 1 PD 0332991 100 mg per day
* Dose Level 2 PD 0332991 125 mg per day
Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.
|
Phase II Arm 1: Platin-Resistant HPV-Unrelated SCCHN
n=6 Participants
PD 0332991 125 mg per day will be administered on Days 1 through 21 of each 28 day cycle.
Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.
|
Phase II Arm 2: Cetuximab-Resistant HPV-Unrelated SCCHN
PD 0332991 125 mg per day will be administered on Days 1 through 21 of each 28 day cycle.
Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.
|
Phase II Arm 3:
PD 0332991 125 mg per day will be administered on Days 1 through 21 of each 28 day cycle.
Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.
|
Phase II Arm 3:
PD 0332991 125 mg per day will be administered on Days 1 through 21 of each 28 day cycle.
Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.
|
|---|---|---|---|---|---|
|
Phase I: Most Frequent Adverse Events
Grade 3 Anemia
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Phase I: Most Frequent Adverse Events
Grades 1-2 Thrombocytopenia
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Phase I: Most Frequent Adverse Events
Grade 3 Diarrhea
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Phase I: Most Frequent Adverse Events
Grade 1-2 Infusion Reaction
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Phase I: Most Frequent Adverse Events
Grade 3 Infusion Reaction
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Phase I: Most Frequent Adverse Events
Grade 3 Hypomagnesemia
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Phase I: Most Frequent Adverse Events
Grade 3 Fatigue
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Phase I: Most Frequent Adverse Events
Grades 1-2 Nausea
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Phase I: Most Frequent Adverse Events
Grade 3 Nausea
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Phase I: Most Frequent Adverse Events
Grade 1-2 Vomiting
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Phase I: Most Frequent Adverse Events
Grade 3 Vomiting
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Phase I: Most Frequent Adverse Events
Grade 1-2 Diarrhea
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Phase I: Most Frequent Adverse Events
Grade 1-2 Acneiform Rash
|
2 Participants
|
5 Participants
|
—
|
—
|
—
|
|
Phase I: Most Frequent Adverse Events
Grade 3 Acneiform Rash
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Phase I: Most Frequent Adverse Events
Grade 1-2 Hypomagnesemia
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Phase I: Most Frequent Adverse Events
Grades 1-2 Neutropenia
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Phase I: Most Frequent Adverse Events
Grade 3 Neutropenia
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Phase I: Most Frequent Adverse Events
Grades 1-2 Anemia
|
2 Participants
|
6 Participants
|
—
|
—
|
—
|
|
Phase I: Most Frequent Adverse Events
Grade 3 Thrombocytopenia
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Phase I: Most Frequent Adverse Events
Grades 1-2 Fatigue
|
2 Participants
|
3 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 30 days following completion of treatment (estimated to be 13 months)Population: All arms of the Phase II Portion of the study were combined for this outcome measure as the treatment received was the same for each arm.
Assessed by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Outcome measures
| Measure |
Phase I: Dose Level 1 and Dose Level 2
n=86 Participants
* PD 0332991 will be administered on Days 1 through 21 of each 28 day cycle.
* Dose Level 1 PD 0332991 100 mg per day
* Dose Level 2 PD 0332991 125 mg per day
Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.
|
Phase II Arm 1: Platin-Resistant HPV-Unrelated SCCHN
PD 0332991 125 mg per day will be administered on Days 1 through 21 of each 28 day cycle.
Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.
|
Phase II Arm 2: Cetuximab-Resistant HPV-Unrelated SCCHN
PD 0332991 125 mg per day will be administered on Days 1 through 21 of each 28 day cycle.
Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.
|
Phase II Arm 3:
PD 0332991 125 mg per day will be administered on Days 1 through 21 of each 28 day cycle.
Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.
|
Phase II Arm 3:
PD 0332991 125 mg per day will be administered on Days 1 through 21 of each 28 day cycle.
Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.
|
|---|---|---|---|---|---|
|
Phase II: PD 0332991 Related Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 1-2 platelet count decreased
|
50 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: PD 0332991 Related Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 3-5 platelet count decreased
|
11 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: PD 0332991 Related Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 1-2 neutrophil count decreased
|
28 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: PD 0332991 Related Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 3-5 neutrophil count decreased
|
29 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: PD 0332991 Related Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 1-2 white blood cell count decreased
|
43 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: PD 0332991 Related Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 3-5 white blood cell count decreased
|
24 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: PD 0332991 Related Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 1-2 electrocardiogram QT corrected interval prolonged
|
6 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: PD 0332991 Related Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 3-5 electrocardiogram QT corrected interval prolonged
|
1 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 30 days following completion of treatment (estimated to be 13 months)Population: All arms of the Phase II Portion of the study were combined for this outcome measure as the treatment received was the same for each arm.
Assessed by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Outcome measures
| Measure |
Phase I: Dose Level 1 and Dose Level 2
n=86 Participants
* PD 0332991 will be administered on Days 1 through 21 of each 28 day cycle.
* Dose Level 1 PD 0332991 100 mg per day
* Dose Level 2 PD 0332991 125 mg per day
Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.
|
Phase II Arm 1: Platin-Resistant HPV-Unrelated SCCHN
PD 0332991 125 mg per day will be administered on Days 1 through 21 of each 28 day cycle.
Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.
|
Phase II Arm 2: Cetuximab-Resistant HPV-Unrelated SCCHN
PD 0332991 125 mg per day will be administered on Days 1 through 21 of each 28 day cycle.
Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.
|
Phase II Arm 3:
PD 0332991 125 mg per day will be administered on Days 1 through 21 of each 28 day cycle.
Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.
|
Phase II Arm 3:
PD 0332991 125 mg per day will be administered on Days 1 through 21 of each 28 day cycle.
Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.
|
|---|---|---|---|---|---|
|
Phase II: Cetuximab Related Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 1-2 acneiform rash
|
60 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Cetuximab Related Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 3-5 acneiform rash
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Cetuximab Related Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 1-2 hypomagnesemia
|
23 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Cetuximab Related Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 3-5 hypomagnesemia
|
1 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 30 days following completion of treatment (estimated to be 13 months)Population: All arms of the Phase II Portion of the study were combined for this outcome measure as the treatment received was the same for each arm.
Assessed by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Outcome measures
| Measure |
Phase I: Dose Level 1 and Dose Level 2
n=86 Participants
* PD 0332991 will be administered on Days 1 through 21 of each 28 day cycle.
* Dose Level 1 PD 0332991 100 mg per day
* Dose Level 2 PD 0332991 125 mg per day
Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.
|
Phase II Arm 1: Platin-Resistant HPV-Unrelated SCCHN
PD 0332991 125 mg per day will be administered on Days 1 through 21 of each 28 day cycle.
Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.
|
Phase II Arm 2: Cetuximab-Resistant HPV-Unrelated SCCHN
PD 0332991 125 mg per day will be administered on Days 1 through 21 of each 28 day cycle.
Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.
|
Phase II Arm 3:
PD 0332991 125 mg per day will be administered on Days 1 through 21 of each 28 day cycle.
Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.
|
Phase II Arm 3:
PD 0332991 125 mg per day will be administered on Days 1 through 21 of each 28 day cycle.
Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.
|
|---|---|---|---|---|---|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 1-2 dry skin
|
18 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 3-5 dry skin
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 1-2 dehydration
|
8 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 3-5 dehydration
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 1-2 hypotension
|
8 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 3-5 hypotension
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 1-2 creatinine increased
|
12 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 3-5 creatinine increased
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 1-2 trismus
|
7 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 3-5 trismus
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 1-2 elevated INR
|
6 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 3-5 elevated INR
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 1-2 dysarthria
|
5 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 3-5 dysarthria
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 1-2 hypophosphatemia
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 3-5 hypophosphatemia
|
8 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 1-2 lung infection
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 3-5 lung infection
|
8 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 1-2 febrile neutropenia
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 3-5 febrile neutropenia
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grade 1-2 abdominal pain
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 3-5 abdominal pain
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 1-2 colitis
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 3-5 colitis
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 1-2 tumor hemorrhage
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 3-5 tumor hemorrhage
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 1-2 hematuria
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 3-5 hematuria
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 1-2 duodenal ulcer
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 3-5 duodenal ulcer
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 1-2 esophageal fistula
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 3-5 esophageal fistula
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 1-2 oral cavity fistula
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 3-5 oral cavity fistula
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 1-2 sepsis
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 3-5 sepsis
|
7 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 1-2 duodenal perforation
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 3-5 duodenal perforation
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 1-2 skin infection
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 3-5 skin infection
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 1-2 tracheitis
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 3-5 tracheitis
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 1-2 aspiration
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 3-5 aspiration
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 1-2 pleural effusion
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 3-5 pleural effusion
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 1-2 pneumothorax
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 3-5 pneumothorax
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 1-2 catheter-related infection
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 3-5 catheter-related infection
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 1-2 jejunal obstruction
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 3-5 jejunal obstruction
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 1-2 mucositis oral
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 3-5 mucositis oral
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 1-2 oral hemorrhage
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 3-5 oral hemorrhage
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grade 5 death, not otherwise specified
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 1-2 infusion-related reaction
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 3-5 infusion-related reaction
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 1-2 urinary tract infection
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 3-5 urinary tract infection
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 1-2 respiratory failure
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 3-5 respiratory failure
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 1-2 hypothyroidism
|
5 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 3-5 hypothyroidism
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 1-2 edema face
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 3-5 edema face
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 1-2 non-cardiac chest pain
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 3-5 non-cardiac chest pain
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 1-2 pancreatitis
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 3-5 pancreatitis
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 1-2 encephalopathy
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 3-5 encephalopathy
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 1-2 acute kidney injury
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 3-5 acute kidney injury
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 1-2 proteinuria
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 3-5 proteinuria
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 1-2 thromboembolic event
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 3-5 thromboembolic event
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 1-2 fatigue
|
48 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 3-5 fatigue
|
8 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 1-2 hypoalbuminemia
|
37 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 3-5 hypoalbuminemia
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 1-2 anemia
|
44 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 3-5 anemia
|
20 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 1-2 hyponatremia
|
30 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 3-5 hyponatremia
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 1-2 hypertension
|
24 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 3-5 hypertension
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 1-2 nausea
|
30 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 3-5 nausea
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 1-2 dysphagia
|
30 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 3-5 dysphagia
|
6 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 1-2 dyspnea
|
29 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 3-5 dyspnea
|
5 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 1-2 hypocalcemia
|
19 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 3-5 hypocalcemia
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 1-2 lymphocyte count decreased
|
19 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 3-5 lymphocyte count decreased
|
22 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 1-2 diarrhea
|
21 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 3-5 diarrhea
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 1-2 weight loss
|
24 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 3-5 weight loss
|
6 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 1-2 AST increased
|
22 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 3-5 AST increased
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 1-2 tumor pain
|
18 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 3-5 tumor pain
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 1-2 constipation
|
15 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 3-5 constipation
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 1-2 cough
|
21 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 3-5 cough
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 1-2 anorexia
|
21 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 3-5 anorexia
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 1-2 vomiting
|
17 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 3-5 vomiting
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 1-2 dry mouth
|
13 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 3-5 dry mouth
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 1-2 sinus tachycardia
|
12 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 3-5 sinus tachycardia
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 1-2 alkaline phosphatase increased
|
12 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 3-5 alkaline phosphatase increased
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 1-2 hypokalemia
|
12 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 3-4 hypokalemia
|
11 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 1-2 hyperglycemia
|
11 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 3-5 hyperglycemia
|
11 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 1-2 hypernatremia
|
16 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 3-5 hypernatremia
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 1-2 fever
|
12 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 3-5 fever
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 1-2 dizziness
|
9 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 3-5 dizziness
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 1-2 hypercalcemia
|
9 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events
Grades 3-5 hypercalcemia
|
1 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 5 yearsParticipants were followed every 2 months for up to 5 years or until death, whichever occurs first. PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.
Outcome measures
| Measure |
Phase I: Dose Level 1 and Dose Level 2
n=30 Participants
* PD 0332991 will be administered on Days 1 through 21 of each 28 day cycle.
* Dose Level 1 PD 0332991 100 mg per day
* Dose Level 2 PD 0332991 125 mg per day
Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.
|
Phase II Arm 1: Platin-Resistant HPV-Unrelated SCCHN
n=32 Participants
PD 0332991 125 mg per day will be administered on Days 1 through 21 of each 28 day cycle.
Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.
|
Phase II Arm 2: Cetuximab-Resistant HPV-Unrelated SCCHN
n=24 Participants
PD 0332991 125 mg per day will be administered on Days 1 through 21 of each 28 day cycle.
Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.
|
Phase II Arm 3:
PD 0332991 125 mg per day will be administered on Days 1 through 21 of each 28 day cycle.
Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.
|
Phase II Arm 3:
PD 0332991 125 mg per day will be administered on Days 1 through 21 of each 28 day cycle.
Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.
|
|---|---|---|---|---|---|
|
Phase II: Progression Free Survival (PFS)
|
5.72 months
Interval 3.97 to 7.93
|
3.75 months
Interval 2.93 to 4.37
|
1.82 months
Interval 1.77 to 2.1
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 5 yearsParticipants were followed every 2 months for up to 5 years or until death, whichever occurs first. Overall survival is measured from time of diagnosis to time of death.
Outcome measures
| Measure |
Phase I: Dose Level 1 and Dose Level 2
n=30 Participants
* PD 0332991 will be administered on Days 1 through 21 of each 28 day cycle.
* Dose Level 1 PD 0332991 100 mg per day
* Dose Level 2 PD 0332991 125 mg per day
Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.
|
Phase II Arm 1: Platin-Resistant HPV-Unrelated SCCHN
n=32 Participants
PD 0332991 125 mg per day will be administered on Days 1 through 21 of each 28 day cycle.
Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.
|
Phase II Arm 2: Cetuximab-Resistant HPV-Unrelated SCCHN
n=24 Participants
PD 0332991 125 mg per day will be administered on Days 1 through 21 of each 28 day cycle.
Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.
|
Phase II Arm 3:
PD 0332991 125 mg per day will be administered on Days 1 through 21 of each 28 day cycle.
Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.
|
Phase II Arm 3:
PD 0332991 125 mg per day will be administered on Days 1 through 21 of each 28 day cycle.
Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.
|
|---|---|---|---|---|---|
|
Phase II: Overall Survival (OS)
|
9.75 months
Interval 5.57 to 15.53
|
7.00 months
Interval 4.97 to 9.37
|
9.32 months
Interval 4.39 to 18.35
|
—
|
—
|
SECONDARY outcome
Timeframe: Completion of treatment (estimated to be 12 months)Population: Phase I participants were not evaluable for this outcome measure.
Duration of overall response is measured from the time measurement criteria are met for CR or PR until the first date that recurrent or progressive disease is objectively documented.
Outcome measures
| Measure |
Phase I: Dose Level 1 and Dose Level 2
* PD 0332991 will be administered on Days 1 through 21 of each 28 day cycle.
* Dose Level 1 PD 0332991 100 mg per day
* Dose Level 2 PD 0332991 125 mg per day
Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.
|
Phase II Arm 1: Platin-Resistant HPV-Unrelated SCCHN
PD 0332991 125 mg per day will be administered on Days 1 through 21 of each 28 day cycle.
Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.
|
Phase II Arm 2: Cetuximab-Resistant HPV-Unrelated SCCHN
n=11 Participants
PD 0332991 125 mg per day will be administered on Days 1 through 21 of each 28 day cycle.
Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.
|
Phase II Arm 3:
n=5 Participants
PD 0332991 125 mg per day will be administered on Days 1 through 21 of each 28 day cycle.
Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.
|
Phase II Arm 3:
n=1 Participants
PD 0332991 125 mg per day will be administered on Days 1 through 21 of each 28 day cycle.
Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.
|
|---|---|---|---|---|---|
|
Phase II: Duration of Response
|
—
|
—
|
4.0 months
Interval 1.8 to 5.6
|
6.0 months
Interval 2.0 to 15.5
|
4.0 months
|
Adverse Events
Phase I: Dose Level 1
Serious events: 2 serious events
Other events: 3 other events
Deaths: 3 deaths
Phase I: Dose Level 2
Serious events: 4 serious events
Other events: 6 other events
Deaths: 6 deaths
Phase II Arm 1: Platin-Resistant HPV-Unrelated SCCHN
Serious events: 21 serious events
Other events: 30 other events
Deaths: 26 deaths
Phase II Arm 2: Cetuximab-Resistant HPV-Unrelated SCCHN
Serious events: 16 serious events
Other events: 32 other events
Deaths: 19 deaths
Phase II Arm 3:
Serious events: 9 serious events
Other events: 24 other events
Deaths: 15 deaths
Serious adverse events
| Measure |
Phase I: Dose Level 1
n=3 participants at risk
PD 0332991 100 mg per day will be administered on Days 1 through 21 of each 28 day cycle.
Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.
|
Phase I: Dose Level 2
n=6 participants at risk
PD 0332991 125 mg per day will be administered on Days 1 through 21 of each 28 day cycle.
Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.
|
Phase II Arm 1: Platin-Resistant HPV-Unrelated SCCHN
n=30 participants at risk
PD 0332991 125 mg per day will be administered on Days 1 through 21 of each 28 day cycle.
Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.
|
Phase II Arm 2: Cetuximab-Resistant HPV-Unrelated SCCHN
n=32 participants at risk
PD 0332991 125 mg per day will be administered on Days 1 through 21 of each 28 day cycle.
Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.
|
Phase II Arm 3:
n=24 participants at risk
PD 0332991 125 mg per day will be administered on Days 1 through 21 of each 28 day cycle.
Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
6.7%
2/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Gastrointestinal disorders
Duodenal obstruction
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.1%
1/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Gastrointestinal disorders
Duodenal perforation
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.1%
1/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
6.7%
2/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.1%
1/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
4.2%
1/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Gastrointestinal disorders
Esophageal fistula
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Gastrointestinal disorders
Jejunal obstruction
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Gastrointestinal disorders
Nausa
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
6.7%
2/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Gastrointestinal disorders
Oral cavity fistula
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.1%
1/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Gastrointestinal disorders
Oral hemorrhage
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
16.7%
1/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
4.2%
1/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
6.7%
2/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
General disorders
Death NOS
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
10.0%
3/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
General disorders
Edema limbs
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
General disorders
Failure to thrive
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
General disorders
Fall
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
6.7%
2/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
6.2%
2/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
General disorders
Fatigue
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
6.7%
2/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
General disorders
Fever
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.1%
1/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
8.3%
2/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
General disorders
Infusion related reaction
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
16.7%
1/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Infections and infestations
Influenza
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
16.7%
1/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
16.7%
1/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
26.7%
8/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
9.4%
3/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
12.5%
3/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Infections and infestations
Meningitis
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
6.7%
2/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
9.4%
3/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
4.2%
1/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Infections and infestations
Skin infection
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
16.7%
1/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
6.7%
2/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Infections and infestations
Tracheitis
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.1%
1/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.1%
1/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
4.2%
1/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Infections and infestations
Wound infection
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.1%
1/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Injury, poisoning and procedural complications
Intestinal stoma leak
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
16.7%
1/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
6.7%
2/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.1%
1/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Facial muscle weakness
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.1%
1/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
16.7%
1/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
6.2%
2/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
4.2%
1/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
4.2%
1/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.1%
1/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
1/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.1%
1/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
4.2%
1/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.1%
1/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal hemorrhage
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
4.2%
1/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal hemorrhage
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
4.2%
1/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.1%
1/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.1%
1/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
16.7%
1/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
4.2%
1/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
Other adverse events
| Measure |
Phase I: Dose Level 1
n=3 participants at risk
PD 0332991 100 mg per day will be administered on Days 1 through 21 of each 28 day cycle.
Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.
|
Phase I: Dose Level 2
n=6 participants at risk
PD 0332991 125 mg per day will be administered on Days 1 through 21 of each 28 day cycle.
Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.
|
Phase II Arm 1: Platin-Resistant HPV-Unrelated SCCHN
n=30 participants at risk
PD 0332991 125 mg per day will be administered on Days 1 through 21 of each 28 day cycle.
Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.
|
Phase II Arm 2: Cetuximab-Resistant HPV-Unrelated SCCHN
n=32 participants at risk
PD 0332991 125 mg per day will be administered on Days 1 through 21 of each 28 day cycle.
Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.
|
Phase II Arm 3:
n=24 participants at risk
PD 0332991 125 mg per day will be administered on Days 1 through 21 of each 28 day cycle.
Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.
|
|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Inguinal hernia
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
16.7%
1/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Injury, poisoning and procedural complications
Intestinal stoma leak
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
16.7%
1/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
16.7%
1/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
33.3%
10/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
18.8%
6/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
25.0%
6/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Injury, poisoning and procedural complications
Skin ulceration
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
13.3%
4/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
4.2%
1/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Injury, poisoning and procedural complications
Tracheal hemorrhage
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.1%
1/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
33.3%
1/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
16.7%
1/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
16.7%
5/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
33.3%
2/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
23.3%
7/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.1%
1/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
8.3%
2/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
16.7%
1/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
23.3%
7/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
18.8%
6/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
29.2%
7/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
3/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
100.0%
6/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
100.0%
30/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
75.0%
24/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
70.8%
17/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.1%
1/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
4.2%
1/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Cardiac disorders
Constrictive pericarditis
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
10.0%
3/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.1%
1/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
8.3%
2/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
33.3%
2/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
66.7%
20/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
37.5%
12/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
16.7%
4/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
6.7%
2/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Ear and labyrinth disorders
Hearing imparied
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
16.7%
5/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.1%
1/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
8.3%
2/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Ear and labyrinth disorders
Otorrhea
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
8.3%
2/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.1%
1/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.1%
1/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Endocrine disorders
Hypoparathyroidism
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
16.7%
5/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Endocrine disorders
Hypothrydodism
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
12.5%
4/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
20.8%
5/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Eye disorders
Blurred vision
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
6.7%
2/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.1%
1/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Eye disorders
Conjuctivitis
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
10.0%
3/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
6.2%
2/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Eye disorders
Dry eye
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Eye disorders
Eye discomfort
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Eye disorders
Melanocytic nevus
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
6.7%
2/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
9.4%
3/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
16.7%
4/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Gastrointestinal disorders
Anal hemorrhage
|
33.3%
1/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.1%
1/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.1%
1/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
16.7%
1/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
30.0%
9/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
18.8%
6/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
12.5%
3/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
1/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
16.7%
1/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
40.0%
12/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
31.2%
10/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
12.5%
3/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Gastrointestinal disorders
Dry mouth
|
33.3%
1/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
50.0%
3/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
60.0%
18/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
40.6%
13/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
41.7%
10/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
6.7%
2/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
9.4%
3/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
4.2%
1/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
50.0%
3/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
63.3%
19/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
40.6%
13/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
33.3%
8/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Gastrointestinal disorders
Esophageal fistula
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Gastrointestinal disorders
Fecal incontinence
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
4.2%
1/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
6.2%
2/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
20.8%
5/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.1%
1/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Gastrointestinal disorders
Hypersalivation
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
16.7%
1/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
6.2%
2/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Gastrointestinal disorders
Mouth sores
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
4.2%
1/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Gastrointestinal disorders
Mucositis oral
|
33.3%
1/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
33.3%
10/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
15.6%
5/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
20.8%
5/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
33.3%
2/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
33.3%
10/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
56.2%
18/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
29.2%
7/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Gastrointestinal disorders
Oral bleeding
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
6.2%
2/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Gastrointestinal disorders
Oral cavity fistula
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
16.7%
1/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Gastrointestinal disorders
Oral dysesthesia
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
8.3%
2/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Gastrointestinal disorders
Oral hemorrhage
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
4.2%
1/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Gastrointestinal disorders
Oral pain
|
66.7%
2/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
33.3%
2/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
6.2%
2/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
12.5%
3/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Gastrointestinal disorders
Rectal bleeding
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Gastrointestinal disorders
Sore tongue
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
4.2%
1/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
16.7%
1/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
16.7%
5/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
31.2%
10/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
12.5%
3/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
General disorders
Chills
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
26.7%
8/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
15.6%
5/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
12.5%
3/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
General disorders
Edema face
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
13.3%
4/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
12.5%
4/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
12.5%
3/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
General disorders
Edema limbs
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
20.0%
6/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
6.2%
2/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
8.3%
2/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
General disorders
Facial pain
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
6.7%
2/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
8.3%
2/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
General disorders
Fall
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
16.7%
1/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
13.3%
4/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
9.4%
3/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
8.3%
2/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
General disorders
Fatigue
|
66.7%
2/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
50.0%
3/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
86.7%
26/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
56.2%
18/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
70.8%
17/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
General disorders
Fever
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
20.0%
6/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
9.4%
3/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
4.2%
1/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
General disorders
Flu like symptoms
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
16.7%
1/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
General disorders
Hypothermia
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
16.7%
1/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
General disorders
Infusion related reaction
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
16.7%
1/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
10.0%
3/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
8.3%
2/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
General disorders
Irritability
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
General disorders
Localized edema
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
16.7%
1/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
General disorders
Malaise
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
20.0%
6/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
9.4%
3/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
4.2%
1/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
General disorders
Neck edema
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
6.7%
2/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
4.2%
1/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
16.7%
1/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
16.7%
5/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
12.5%
3/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
General disorders
Pain
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
6.7%
2/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.1%
1/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
4.2%
1/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
General disorders
Pain in extremity
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
6.7%
2/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
4.2%
1/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
General disorders
Restless leg
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
4.2%
1/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
General disorders
Upper back edema
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.1%
1/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
4.2%
1/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Infections and infestations
Bone infection
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Infections and infestations
Bronchial infection
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
4.2%
1/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Infections and infestations
Eye infection
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.1%
1/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Infections and infestations
Herpertic blepharitis
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.1%
1/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Infections and infestations
Nail infection
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
16.7%
1/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Infections and infestations
Otitis media
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.1%
1/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Infections and infestations
Paronychia
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
16.7%
1/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
40.0%
12/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
15.6%
5/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
20.8%
5/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.1%
1/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
6.7%
2/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.1%
1/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Infections and infestations
Skin infection
|
33.3%
1/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
20.0%
6/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
9.4%
3/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
4.2%
1/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Infections and infestations
Upper respiratory infection
|
33.3%
1/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
6.7%
2/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
6.2%
2/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
4.2%
1/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
6.7%
2/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Infections and infestations
Wound infection
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.1%
1/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Injury, poisoning and procedural complications
Hand wound
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Investigations
CPK increased
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Investigations
Cardiac troponin I increased
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
10.0%
3/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Investigations
Cholesterol high
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.1%
1/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
4.2%
1/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Investigations
Creatinine increased
|
33.3%
1/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
33.3%
2/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
26.7%
8/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
6.2%
2/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
20.8%
5/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
33.3%
10/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
6.2%
2/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
4.2%
1/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Investigations
GGT increased
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Investigations
INR increased
|
33.3%
1/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
33.3%
2/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
50.0%
15/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
21.9%
7/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
16.7%
4/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Investigations
Lipase increased
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
4.2%
1/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Investigations
Lymphocyte count decreased
|
100.0%
3/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
100.0%
6/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
93.3%
28/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
43.8%
14/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
79.2%
19/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Investigations
Neutrophil count decreased
|
66.7%
2/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
66.7%
4/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
86.7%
26/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
56.2%
18/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
58.3%
14/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Investigations
Platelet count decreased
|
66.7%
2/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
50.0%
3/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
76.7%
23/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
71.9%
23/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
66.7%
16/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Investigations
Weight loss
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
50.0%
15/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
28.1%
9/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
33.3%
8/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Investigations
White blood cell decreased
|
66.7%
2/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
100.0%
6/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
86.7%
26/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
71.9%
23/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
79.2%
19/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
13.3%
4/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
9.4%
3/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
1/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
33.3%
2/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
56.7%
17/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
18.8%
6/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
29.2%
7/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Metabolism and nutrition disorders
Dehydration
|
33.3%
1/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
16.7%
1/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
16.7%
5/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
15.6%
5/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
4.2%
1/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
6.2%
2/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
33.3%
1/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
26.7%
8/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
12.5%
4/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
4.2%
1/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
33.3%
1/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
16.7%
1/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
33.3%
10/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
34.4%
11/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
4.2%
1/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
33.3%
1/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
13.3%
4/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
9.4%
3/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
4.2%
1/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Metabolism and nutrition disorders
Hyperlipidemia
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
12.5%
3/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.1%
1/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
20.0%
6/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
15.6%
5/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
16.7%
1/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.1%
1/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
100.0%
3/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
50.0%
3/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
66.7%
20/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
46.9%
15/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
29.2%
7/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
66.7%
2/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
66.7%
4/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
56.7%
17/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
21.9%
7/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
20.8%
5/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
33.3%
1/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
16.7%
5/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
9.4%
3/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
4.2%
1/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
16.7%
1/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
43.3%
13/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
28.1%
9/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
8.3%
2/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
66.7%
2/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
33.3%
2/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
43.3%
13/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
31.2%
10/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
20.8%
5/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
33.3%
1/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
66.7%
4/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
73.3%
22/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
40.6%
13/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
20.8%
5/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
33.3%
1/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
33.3%
2/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
23.3%
7/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
12.5%
4/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
8.3%
2/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.1%
1/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
8.3%
2/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Axilla pain
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
33.3%
2/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
30.0%
9/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
6.2%
2/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
16.7%
4/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Clavicular pain
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
6.7%
2/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
4.2%
1/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
20.0%
6/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
6.2%
2/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Head soft tissue necrosis
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.1%
1/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Hip pain
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Jaw pain
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.1%
1/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased cervical spine
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
6.2%
2/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Knee pain
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.1%
1/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Kyphosis
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
13.3%
4/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.1%
1/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left sided
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.1%
1/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
4.2%
1/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
30.0%
9/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
18.8%
6/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
12.5%
3/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.1%
1/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of lunate
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Superficial soft tissue fibrosis
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
6.2%
2/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
4.2%
1/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
33.3%
1/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
20.0%
6/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
25.0%
8/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
16.7%
4/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor hemorrhage
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
16.7%
1/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
26.7%
8/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
21.9%
7/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
12.5%
3/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Nervous system disorders
Abdominal numbness
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
20.0%
6/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
28.1%
9/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
12.5%
3/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Nervous system disorders
Dysarthria
|
33.3%
1/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
30.0%
9/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
21.9%
7/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
16.7%
4/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
10.0%
3/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
4.2%
1/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Nervous system disorders
Facial drooping
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
9.4%
3/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Nervous system disorders
Facial palsy
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
4.2%
1/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
30.0%
9/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
18.8%
6/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
12.5%
3/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.1%
1/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
6.7%
2/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Nervous system disorders
Movements involuntary
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
4.2%
1/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
50.0%
3/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
23.3%
7/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
15.6%
5/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
4.2%
1/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
9.4%
3/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
6.7%
2/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
6.7%
2/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
9.4%
3/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
8.3%
2/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
23.3%
7/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.1%
1/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
4.2%
1/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
16.7%
1/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
10.0%
3/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
12.5%
4/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
4.2%
1/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Psychiatric disorders
Hallucinations
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
8.3%
2/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.1%
1/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
12.5%
3/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
4.2%
1/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Renal and urinary disorders
Hematuria
|
33.3%
1/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
30.0%
9/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
12.5%
4/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
8.3%
2/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
23.3%
7/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
6.2%
2/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
4.2%
1/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
6.2%
2/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
4.2%
1/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Renal and urinary disorders
Urine discoloration
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
10.0%
3/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.1%
1/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
12.5%
4/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.1%
1/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
8.3%
2/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
16.7%
1/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
4.2%
1/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
33.3%
2/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
33.3%
10/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
34.4%
11/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
25.0%
6/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
33.3%
2/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
63.3%
19/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
31.2%
10/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
33.3%
8/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
16.7%
5/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
15.6%
5/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
12.5%
3/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
33.3%
1/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
23.3%
7/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
12.5%
4/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
8.3%
2/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
6.2%
2/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal hemorrhage
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.1%
1/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.1%
1/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal obstruction
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Left vocal cord paralysis
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
16.7%
1/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
20.0%
6/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
9.4%
3/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
12.5%
3/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal regurgitation of liquids
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Oromaxillary fistula
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal fistula
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal hemorrhage
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
4.2%
1/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
12.5%
4/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
4.2%
1/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.1%
1/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
33.3%
1/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
33.3%
2/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
6.7%
2/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
9.4%
3/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
4.2%
1/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
43.3%
13/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
18.8%
6/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
20.8%
5/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.1%
1/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.1%
1/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
8.3%
2/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
23.3%
7/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
9.4%
3/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
8.3%
2/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
6.7%
2/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
6.7%
2/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.1%
1/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
26.7%
8/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
15.6%
5/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
8.3%
2/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Bed sores
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.1%
1/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Blisters on palms and toe
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Dermal neck nodules
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
4.2%
1/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
66.7%
2/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
33.3%
2/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
60.0%
18/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
34.4%
11/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
41.7%
10/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
23.3%
7/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
9.4%
3/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Increased mucous secretions
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.1%
1/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Lesion (unknown/furuncle)
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.1%
1/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
4.2%
1/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.1%
1/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
6.7%
2/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
33.3%
1/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Periorbital edema
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.1%
1/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
6.2%
2/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
66.7%
2/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
83.3%
5/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
70.0%
21/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
46.9%
15/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
83.3%
20/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
9.4%
3/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
4.2%
1/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
13.3%
4/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
9.4%
3/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
33.3%
10/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
18.8%
6/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
8.3%
2/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.1%
1/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Telangiectasia
|
33.3%
1/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Vascular disorders
Hematoma
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.3%
1/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.1%
1/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Vascular disorders
Hypertension
|
66.7%
2/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
66.7%
4/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
83.3%
25/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
40.6%
13/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
50.0%
12/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
23.3%
7/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
15.6%
5/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
8.3%
2/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Vascular disorders
Lymphedema
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
13.3%
4/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
4.2%
1/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/3 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/6 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/30 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
3.1%
1/32 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
0.00%
0/24 • Adverse events were followed from start of study treatment until 30 days following the last day of study treatment, up to approximately 13 months. All-Cause Morality was assessed from start of study treatment up to 5 years.
|
Additional Information
Douglas R. Adkins, M.D.
Washington University School of Medicine
Phone: 314-362-4471
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place