Trial Outcomes & Findings for ADI-PEG 20 in Combination With Gemcitabine and Docetaxel for the Treatment of Soft Tissue Sarcoma, Osteosarcoma, Ewing's Sarcoma, and Small Cell Lung Cancer (NCT NCT03449901)
NCT ID: NCT03449901
Last Updated: 2025-12-11
Results Overview
* PFS: defined as time on study to time patients progressed on the drug combination or death or latest follow-up if progression/death is not observed yet * Progressive disease: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
98 participants
Primary outcome timeframe
Through completion of follow-up (median follow-up 494 days, full range of 5-1500 days).
Results posted on
2025-12-11
Participant Flow
1 patient was enrolled, but never initiated treatment.
Participant milestones
| Measure |
Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel
Patients enrolling to Cohort 1 must be diagnosed with soft tissue sarcoma.
* ADI-PEG 20 will be given on Day -7 of Cycle 1 and then on Days 1, 8, and 15 of each subsequent cycle. Cycles are 21 days. ADI-PEG 20 will be given on an outpatient basis at a dose of 36 mg/m2 via intramuscular injection into either the deltoid or gluteal muscle.
* Gemcitabine will be given intravenously at a dose of 600 mg/m2 over 90 minutes on Days 1 and 8 of each cycle. Docetaxel will be given intravenously at a dose of 60 mg/m2 over 60 minutes on Day 8 of each cycle. Patients started on gemcitabine at a dose of 900 mg/m2 or 750 mg/m2 or docetaxel at a dose of 75 mg/m2 per previous protocol version will be allowed to continue at that dose level
* After Cycle 8, patients may continue on ADI-PEG 20 alone (without gemcitabine and docetaxel) upon request.
* Treatment may continue for up to 34 cycles (103 weeks)
|
Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel
Patients enrolling to Cohort 2 must be diagnosed with osteosarcoma, Ewing's sarcoma, or small cell lung cancer.
* ADI-PEG 20 will be given on Day -7 of Cycle 1 and then on Days 1, 8, and 15 of each subsequent cycle. Cycles are 21 days. ADI-PEG 20 will be given on an outpatient basis at a dose of 36 mg/m2 via intramuscular injection into either the deltoid or gluteal muscle.
* Gemcitabine will be given intravenously at a dose of 600 mg/m2 over 90 minutes on Days 1 and 8 of each cycle. Docetaxel will be given intravenously at a dose of 60 mg/m2 over 60 minutes on Day 8 of each cycle. Patients started on gemcitabine at a dose of 900 mg/m2 or 750 mg/m2 or docetaxel at a dose of 75 mg/m2 per previous protocol version will be allowed to continue at that dose level
* After Cycle 8, patients may continue on ADI-PEG 20 alone (without gemcitabine and docetaxel) upon request.
* Treatment may continue for up to 34 cycles (103 weeks)
|
|---|---|---|
|
Overall Study
STARTED
|
82
|
15
|
|
Overall Study
COMPLETED
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
81
|
15
|
Reasons for withdrawal
| Measure |
Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel
Patients enrolling to Cohort 1 must be diagnosed with soft tissue sarcoma.
* ADI-PEG 20 will be given on Day -7 of Cycle 1 and then on Days 1, 8, and 15 of each subsequent cycle. Cycles are 21 days. ADI-PEG 20 will be given on an outpatient basis at a dose of 36 mg/m2 via intramuscular injection into either the deltoid or gluteal muscle.
* Gemcitabine will be given intravenously at a dose of 600 mg/m2 over 90 minutes on Days 1 and 8 of each cycle. Docetaxel will be given intravenously at a dose of 60 mg/m2 over 60 minutes on Day 8 of each cycle. Patients started on gemcitabine at a dose of 900 mg/m2 or 750 mg/m2 or docetaxel at a dose of 75 mg/m2 per previous protocol version will be allowed to continue at that dose level
* After Cycle 8, patients may continue on ADI-PEG 20 alone (without gemcitabine and docetaxel) upon request.
* Treatment may continue for up to 34 cycles (103 weeks)
|
Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel
Patients enrolling to Cohort 2 must be diagnosed with osteosarcoma, Ewing's sarcoma, or small cell lung cancer.
* ADI-PEG 20 will be given on Day -7 of Cycle 1 and then on Days 1, 8, and 15 of each subsequent cycle. Cycles are 21 days. ADI-PEG 20 will be given on an outpatient basis at a dose of 36 mg/m2 via intramuscular injection into either the deltoid or gluteal muscle.
* Gemcitabine will be given intravenously at a dose of 600 mg/m2 over 90 minutes on Days 1 and 8 of each cycle. Docetaxel will be given intravenously at a dose of 60 mg/m2 over 60 minutes on Day 8 of each cycle. Patients started on gemcitabine at a dose of 900 mg/m2 or 750 mg/m2 or docetaxel at a dose of 75 mg/m2 per previous protocol version will be allowed to continue at that dose level
* After Cycle 8, patients may continue on ADI-PEG 20 alone (without gemcitabine and docetaxel) upon request.
* Treatment may continue for up to 34 cycles (103 weeks)
|
|---|---|---|
|
Overall Study
Progression
|
57
|
12
|
|
Overall Study
Adverse Event
|
3
|
0
|
|
Overall Study
Death
|
6
|
2
|
|
Overall Study
Withdrawal by Subject
|
12
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Patient elected for surgical intervention
|
1
|
0
|
|
Overall Study
Patient off for other complicating disease
|
1
|
0
|
Baseline Characteristics
ADI-PEG 20 in Combination With Gemcitabine and Docetaxel for the Treatment of Soft Tissue Sarcoma, Osteosarcoma, Ewing's Sarcoma, and Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel
n=82 Participants
Patients enrolling to Cohort 1 must be diagnosed with soft tissue sarcoma.
* ADI-PEG 20 will be given on Day -7 of Cycle 1 and then on Days 1, 8, and 15 of each subsequent cycle. Cycles are 21 days. ADI-PEG 20 will be given on an outpatient basis at a dose of 36 mg/m2 via intramuscular injection into either the deltoid or gluteal muscle.
* Gemcitabine will be given intravenously at a dose of 600 mg/m2 over 90 minutes on Days 1 and 8 of each cycle. Docetaxel will be given intravenously at a dose of 60 mg/m2 over 60 minutes on Day 8 of each cycle. Patients started on gemcitabine at a dose of 900 mg/m2 or 750 mg/m2 or docetaxel at a dose of 75 mg/m2 per previous protocol version will be allowed to continue at that dose level
* After Cycle 8, patients may continue on ADI-PEG 20 alone (without gemcitabine and docetaxel) upon request.
* Treatment may continue for up to 34 cycles (103 weeks)
|
Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel
n=15 Participants
Patients enrolling to Cohort 2 must be diagnosed with osteosarcoma, Ewing's sarcoma, or small cell lung cancer.
* ADI-PEG 20 will be given on Day -7 of Cycle 1 and then on Days 1, 8, and 15 of each subsequent cycle. Cycles are 21 days. ADI-PEG 20 will be given on an outpatient basis at a dose of 36 mg/m2 via intramuscular injection into either the deltoid or gluteal muscle.
* Gemcitabine will be given intravenously at a dose of 600 mg/m2 over 90 minutes on Days 1 and 8 of each cycle. Docetaxel will be given intravenously at a dose of 60 mg/m2 over 60 minutes on Day 8 of each cycle. Patients started on gemcitabine at a dose of 900 mg/m2 or 750 mg/m2 or docetaxel at a dose of 75 mg/m2 per previous protocol version will be allowed to continue at that dose level
* After Cycle 8, patients may continue on ADI-PEG 20 alone (without gemcitabine and docetaxel) upon request.
* Treatment may continue for up to 34 cycles (103 weeks)
|
Total
n=97 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57 years
n=9 Participants
|
30 years
n=6 Participants
|
55 years
n=9 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=9 Participants
|
7 Participants
n=6 Participants
|
52 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=9 Participants
|
8 Participants
n=6 Participants
|
45 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
4 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
78 Participants
n=9 Participants
|
13 Participants
n=6 Participants
|
91 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
5 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
7 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
71 Participants
n=9 Participants
|
11 Participants
n=6 Participants
|
82 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
3 Participants
n=6 Participants
|
3 Participants
n=9 Participants
|
|
Region of Enrollment
United States
|
82 participants
n=9 Participants
|
15 participants
n=6 Participants
|
97 participants
n=9 Participants
|
PRIMARY outcome
Timeframe: Through completion of follow-up (median follow-up 494 days, full range of 5-1500 days).Population: PFS was evaluated only for Cohort 1; therefore, no participants in Cohort 2 were analyzed for this outcome measure. 2 participants in Cohort 1 were not evaluable for this outcome measure.
* PFS: defined as time on study to time patients progressed on the drug combination or death or latest follow-up if progression/death is not observed yet * Progressive disease: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).
Outcome measures
| Measure |
Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel
n=80 Participants
* ADI-PEG 20 will be given on Day -7 of Cycle 1 and then on Days 1, 8, and 15 of each subsequent cycle. Cycles are 21 days. ADI-PEG 20 will be given on an outpatient basis at a dose of 36 mg/m2 via intramuscular injection into either the deltoid or gluteal muscle.
* Gemcitabine will be given intravenously at a dose of 600 mg/m2 over 90 minutes on Days 1 and 8 of each cycle. Docetaxel will be given intravenously at a dose of 60 mg/m2 over 60 minutes on Day 8 of each cycle. Patients started on gemcitabine at a dose of 900 mg/m2 or 750 mg/m2 or docetaxel at a dose of 75 mg/m2 per previous protocol version will be allowed to continue at that dose level
* After Cycle 8, patients may continue on ADI-PEG 20 alone (without gemcitabine and docetaxel) upon request.
* Treatment may continue for up to 34 cycles (103 weeks)
|
Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel
* ADI-PEG 20 will be given on Day -7 of Cycle 1 and then on Days 1, 8, and 15 of each subsequent cycle. Cycles are 21 days. ADI-PEG 20 will be given on an outpatient basis at a dose of 36 mg/m2 via intramuscular injection into either the deltoid or gluteal muscle.
* Gemcitabine will be given intravenously at a dose of 600 mg/m2 over 90 minutes on Days 1 and 8 of each cycle. Docetaxel will be given intravenously at a dose of 60 mg/m2 over 60 minutes on Day 8 of each cycle. Patients started on gemcitabine at a dose of 900 mg/m2 or 750 mg/m2 or docetaxel at a dose of 75 mg/m2 per previous protocol version will be allowed to continue at that dose level
* After Cycle 8, patients may continue on ADI-PEG 20 alone (without gemcitabine and docetaxel) upon request.
* Treatment may continue for up to 34 cycles (103 weeks)
|
Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel
* ADI-PEG 20 will be given on Day -7 of Cycle 1 and then on Days 1, 8, and 15 of each subsequent cycle. Cycles are 21 days. ADI-PEG 20 will be given on an outpatient basis at a dose of 36 mg/m2 via intramuscular injection into either the deltoid or gluteal muscle.
* Gemcitabine will be given intravenously at a dose of 900 mg/m2 over 90 minutes on Days 1 and 8 of each cycle. Docetaxel will be given intravenously at a dose of 60 mg/m2 over 60 minutes on Day 8 of each cycle. Patients started on gemcitabine at a dose of 900 mg/m2 or 750 mg/m2 or docetaxel at a dose of 75 mg/m2 per previous protocol version will be allowed to continue at that dose level
* After Cycle 8, patients may continue on ADI-PEG 20 alone (without gemcitabine and docetaxel) upon request.
* Treatment may continue for up to 34 cycles (103 weeks)
|
Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel
* ADI-PEG 20 will be given on Day -7 of Cycle 1 and then on Days 1, 8, and 15 of each subsequent cycle. Cycles are 21 days. ADI-PEG 20 will be given on an outpatient basis at a dose of 36 mg/m2 via intramuscular injection into either the deltoid or gluteal muscle.
* Gemcitabine will be given intravenously at a dose of 600 mg/m2 over 90 minutes on Days 1 and 8 of each cycle. Docetaxel will be given intravenously at a dose of 60 mg/m2 over 60 minutes on Day 8 of each cycle. Patients started on gemcitabine at a dose of 900 mg/m2 or 750 mg/m2 or docetaxel at a dose of 75 mg/m2 per previous protocol version will be allowed to continue at that dose level
* After Cycle 8, patients may continue on ADI-PEG 20 alone (without gemcitabine and docetaxel) upon request.
* Treatment may continue for up to 34 cycles (103 weeks)
|
|---|---|---|---|---|
|
Progression-free Survival (PFS) (Cohort 1 Only)
|
5.0597 months
Interval 2.9898 to 7.5238
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through completion of follow-up (median follow-up 494 days, full range of 5-1500 days).Population: OS was evaluated only for Cohort 1; therefore, no participants in Cohort 2 were analyzed for this outcome measure. 7 participants in Cohort 1 were not evaluable for this outcome measure.
-OS: defined as time on study to time of death due to any reasons or latest follow-up (whichever is earlier)
Outcome measures
| Measure |
Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel
n=75 Participants
* ADI-PEG 20 will be given on Day -7 of Cycle 1 and then on Days 1, 8, and 15 of each subsequent cycle. Cycles are 21 days. ADI-PEG 20 will be given on an outpatient basis at a dose of 36 mg/m2 via intramuscular injection into either the deltoid or gluteal muscle.
* Gemcitabine will be given intravenously at a dose of 600 mg/m2 over 90 minutes on Days 1 and 8 of each cycle. Docetaxel will be given intravenously at a dose of 60 mg/m2 over 60 minutes on Day 8 of each cycle. Patients started on gemcitabine at a dose of 900 mg/m2 or 750 mg/m2 or docetaxel at a dose of 75 mg/m2 per previous protocol version will be allowed to continue at that dose level
* After Cycle 8, patients may continue on ADI-PEG 20 alone (without gemcitabine and docetaxel) upon request.
* Treatment may continue for up to 34 cycles (103 weeks)
|
Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel
* ADI-PEG 20 will be given on Day -7 of Cycle 1 and then on Days 1, 8, and 15 of each subsequent cycle. Cycles are 21 days. ADI-PEG 20 will be given on an outpatient basis at a dose of 36 mg/m2 via intramuscular injection into either the deltoid or gluteal muscle.
* Gemcitabine will be given intravenously at a dose of 600 mg/m2 over 90 minutes on Days 1 and 8 of each cycle. Docetaxel will be given intravenously at a dose of 60 mg/m2 over 60 minutes on Day 8 of each cycle. Patients started on gemcitabine at a dose of 900 mg/m2 or 750 mg/m2 or docetaxel at a dose of 75 mg/m2 per previous protocol version will be allowed to continue at that dose level
* After Cycle 8, patients may continue on ADI-PEG 20 alone (without gemcitabine and docetaxel) upon request.
* Treatment may continue for up to 34 cycles (103 weeks)
|
Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel
* ADI-PEG 20 will be given on Day -7 of Cycle 1 and then on Days 1, 8, and 15 of each subsequent cycle. Cycles are 21 days. ADI-PEG 20 will be given on an outpatient basis at a dose of 36 mg/m2 via intramuscular injection into either the deltoid or gluteal muscle.
* Gemcitabine will be given intravenously at a dose of 900 mg/m2 over 90 minutes on Days 1 and 8 of each cycle. Docetaxel will be given intravenously at a dose of 60 mg/m2 over 60 minutes on Day 8 of each cycle. Patients started on gemcitabine at a dose of 900 mg/m2 or 750 mg/m2 or docetaxel at a dose of 75 mg/m2 per previous protocol version will be allowed to continue at that dose level
* After Cycle 8, patients may continue on ADI-PEG 20 alone (without gemcitabine and docetaxel) upon request.
* Treatment may continue for up to 34 cycles (103 weeks)
|
Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel
* ADI-PEG 20 will be given on Day -7 of Cycle 1 and then on Days 1, 8, and 15 of each subsequent cycle. Cycles are 21 days. ADI-PEG 20 will be given on an outpatient basis at a dose of 36 mg/m2 via intramuscular injection into either the deltoid or gluteal muscle.
* Gemcitabine will be given intravenously at a dose of 600 mg/m2 over 90 minutes on Days 1 and 8 of each cycle. Docetaxel will be given intravenously at a dose of 60 mg/m2 over 60 minutes on Day 8 of each cycle. Patients started on gemcitabine at a dose of 900 mg/m2 or 750 mg/m2 or docetaxel at a dose of 75 mg/m2 per previous protocol version will be allowed to continue at that dose level
* After Cycle 8, patients may continue on ADI-PEG 20 alone (without gemcitabine and docetaxel) upon request.
* Treatment may continue for up to 34 cycles (103 weeks)
|
|---|---|---|---|---|
|
Overall Survival (OS) (Cohort 1 Only)
|
18.1359 months
Interval 14.029 to 25.1011
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through completion of treatment (median treatment of 9 months)Population: CBR was evaluated only for Cohort 1; therefore, no participants in Cohort 2 were analyzed for this outcome measure. 8 participants in Cohort 1 were not evaluable for this outcome measure.
* CBR = proportion of patients who have experienced complete response (CR)+ partial response (PR) + stable disease (SD) lasting 24 weeks or longer * CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. 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). * PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. * SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Outcome measures
| Measure |
Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel
n=74 Participants
* ADI-PEG 20 will be given on Day -7 of Cycle 1 and then on Days 1, 8, and 15 of each subsequent cycle. Cycles are 21 days. ADI-PEG 20 will be given on an outpatient basis at a dose of 36 mg/m2 via intramuscular injection into either the deltoid or gluteal muscle.
* Gemcitabine will be given intravenously at a dose of 600 mg/m2 over 90 minutes on Days 1 and 8 of each cycle. Docetaxel will be given intravenously at a dose of 60 mg/m2 over 60 minutes on Day 8 of each cycle. Patients started on gemcitabine at a dose of 900 mg/m2 or 750 mg/m2 or docetaxel at a dose of 75 mg/m2 per previous protocol version will be allowed to continue at that dose level
* After Cycle 8, patients may continue on ADI-PEG 20 alone (without gemcitabine and docetaxel) upon request.
* Treatment may continue for up to 34 cycles (103 weeks)
|
Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel
* ADI-PEG 20 will be given on Day -7 of Cycle 1 and then on Days 1, 8, and 15 of each subsequent cycle. Cycles are 21 days. ADI-PEG 20 will be given on an outpatient basis at a dose of 36 mg/m2 via intramuscular injection into either the deltoid or gluteal muscle.
* Gemcitabine will be given intravenously at a dose of 600 mg/m2 over 90 minutes on Days 1 and 8 of each cycle. Docetaxel will be given intravenously at a dose of 60 mg/m2 over 60 minutes on Day 8 of each cycle. Patients started on gemcitabine at a dose of 900 mg/m2 or 750 mg/m2 or docetaxel at a dose of 75 mg/m2 per previous protocol version will be allowed to continue at that dose level
* After Cycle 8, patients may continue on ADI-PEG 20 alone (without gemcitabine and docetaxel) upon request.
* Treatment may continue for up to 34 cycles (103 weeks)
|
Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel
* ADI-PEG 20 will be given on Day -7 of Cycle 1 and then on Days 1, 8, and 15 of each subsequent cycle. Cycles are 21 days. ADI-PEG 20 will be given on an outpatient basis at a dose of 36 mg/m2 via intramuscular injection into either the deltoid or gluteal muscle.
* Gemcitabine will be given intravenously at a dose of 900 mg/m2 over 90 minutes on Days 1 and 8 of each cycle. Docetaxel will be given intravenously at a dose of 60 mg/m2 over 60 minutes on Day 8 of each cycle. Patients started on gemcitabine at a dose of 900 mg/m2 or 750 mg/m2 or docetaxel at a dose of 75 mg/m2 per previous protocol version will be allowed to continue at that dose level
* After Cycle 8, patients may continue on ADI-PEG 20 alone (without gemcitabine and docetaxel) upon request.
* Treatment may continue for up to 34 cycles (103 weeks)
|
Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel
* ADI-PEG 20 will be given on Day -7 of Cycle 1 and then on Days 1, 8, and 15 of each subsequent cycle. Cycles are 21 days. ADI-PEG 20 will be given on an outpatient basis at a dose of 36 mg/m2 via intramuscular injection into either the deltoid or gluteal muscle.
* Gemcitabine will be given intravenously at a dose of 600 mg/m2 over 90 minutes on Days 1 and 8 of each cycle. Docetaxel will be given intravenously at a dose of 60 mg/m2 over 60 minutes on Day 8 of each cycle. Patients started on gemcitabine at a dose of 900 mg/m2 or 750 mg/m2 or docetaxel at a dose of 75 mg/m2 per previous protocol version will be allowed to continue at that dose level
* After Cycle 8, patients may continue on ADI-PEG 20 alone (without gemcitabine and docetaxel) upon request.
* Treatment may continue for up to 34 cycles (103 weeks)
|
|---|---|---|---|---|
|
Clinical Benefit Rate (CBR) (Cohort 1 Only)
|
27 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From start of treatment through 30 days after completion of treatment (median treatment of 9 months + 1 month follow-up)-The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for all toxicity reporting.
Outcome measures
| Measure |
Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel
n=33 Participants
* ADI-PEG 20 will be given on Day -7 of Cycle 1 and then on Days 1, 8, and 15 of each subsequent cycle. Cycles are 21 days. ADI-PEG 20 will be given on an outpatient basis at a dose of 36 mg/m2 via intramuscular injection into either the deltoid or gluteal muscle.
* Gemcitabine will be given intravenously at a dose of 600 mg/m2 over 90 minutes on Days 1 and 8 of each cycle. Docetaxel will be given intravenously at a dose of 60 mg/m2 over 60 minutes on Day 8 of each cycle. Patients started on gemcitabine at a dose of 900 mg/m2 or 750 mg/m2 or docetaxel at a dose of 75 mg/m2 per previous protocol version will be allowed to continue at that dose level
* After Cycle 8, patients may continue on ADI-PEG 20 alone (without gemcitabine and docetaxel) upon request.
* Treatment may continue for up to 34 cycles (103 weeks)
|
Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel
n=25 Participants
* ADI-PEG 20 will be given on Day -7 of Cycle 1 and then on Days 1, 8, and 15 of each subsequent cycle. Cycles are 21 days. ADI-PEG 20 will be given on an outpatient basis at a dose of 36 mg/m2 via intramuscular injection into either the deltoid or gluteal muscle.
* Gemcitabine will be given intravenously at a dose of 600 mg/m2 over 90 minutes on Days 1 and 8 of each cycle. Docetaxel will be given intravenously at a dose of 60 mg/m2 over 60 minutes on Day 8 of each cycle. Patients started on gemcitabine at a dose of 900 mg/m2 or 750 mg/m2 or docetaxel at a dose of 75 mg/m2 per previous protocol version will be allowed to continue at that dose level
* After Cycle 8, patients may continue on ADI-PEG 20 alone (without gemcitabine and docetaxel) upon request.
* Treatment may continue for up to 34 cycles (103 weeks)
|
Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel
n=24 Participants
* ADI-PEG 20 will be given on Day -7 of Cycle 1 and then on Days 1, 8, and 15 of each subsequent cycle. Cycles are 21 days. ADI-PEG 20 will be given on an outpatient basis at a dose of 36 mg/m2 via intramuscular injection into either the deltoid or gluteal muscle.
* Gemcitabine will be given intravenously at a dose of 900 mg/m2 over 90 minutes on Days 1 and 8 of each cycle. Docetaxel will be given intravenously at a dose of 60 mg/m2 over 60 minutes on Day 8 of each cycle. Patients started on gemcitabine at a dose of 900 mg/m2 or 750 mg/m2 or docetaxel at a dose of 75 mg/m2 per previous protocol version will be allowed to continue at that dose level
* After Cycle 8, patients may continue on ADI-PEG 20 alone (without gemcitabine and docetaxel) upon request.
* Treatment may continue for up to 34 cycles (103 weeks)
|
Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel
n=15 Participants
* ADI-PEG 20 will be given on Day -7 of Cycle 1 and then on Days 1, 8, and 15 of each subsequent cycle. Cycles are 21 days. ADI-PEG 20 will be given on an outpatient basis at a dose of 36 mg/m2 via intramuscular injection into either the deltoid or gluteal muscle.
* Gemcitabine will be given intravenously at a dose of 600 mg/m2 over 90 minutes on Days 1 and 8 of each cycle. Docetaxel will be given intravenously at a dose of 60 mg/m2 over 60 minutes on Day 8 of each cycle. Patients started on gemcitabine at a dose of 900 mg/m2 or 750 mg/m2 or docetaxel at a dose of 75 mg/m2 per previous protocol version will be allowed to continue at that dose level
* After Cycle 8, patients may continue on ADI-PEG 20 alone (without gemcitabine and docetaxel) upon request.
* Treatment may continue for up to 34 cycles (103 weeks)
|
|---|---|---|---|---|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 sinus tachycardia
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 chest pain - cardiac
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 ear pain
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 vertigo
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 tinnitus
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 hyperthyroidism
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 cataract
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 blurred vision
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 watering eyes
|
1 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 retinal tear
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 dry eye
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 abdominal distension
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 abdominal pain
|
3 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 abdominal pain
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 anal hemorrhage
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 anal mucositis
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 ascites
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 ascites
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 bloating
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 colitis
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 colonic hemorrhage
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 colonic perforation
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 constipation
|
8 Participants
|
5 Participants
|
8 Participants
|
2 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 dental caries
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 dental caries
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 diarrhea
|
10 Participants
|
7 Participants
|
7 Participants
|
1 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 diarrhea
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 dry mouth
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 dyspepsia
|
4 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 dysphagia
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 fecal incontinence
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 flatulence
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 gastroesophageal reflux disease
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 hematochezia
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 generalized GI bleed
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 tooth extraction
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 hemorrhoids
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 lower gastrointestinal hemorrhage
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 lip pain
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 mucositis oral
|
6 Participants
|
5 Participants
|
3 Participants
|
2 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 nausea
|
13 Participants
|
8 Participants
|
14 Participants
|
2 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 oral pain
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 rectal hemorrhage
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 small intestinal obstruction
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 typhlitis
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 upper gastrointestinal hemorrhage
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 vomiting
|
6 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 vomiting
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 chills
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 5 death NOS
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 edema face
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 edema limbs
|
9 Participants
|
5 Participants
|
10 Participants
|
2 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 edema limbs
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 edema trunk
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 edema trunk
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 facial pain
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 fatigue
|
16 Participants
|
15 Participants
|
10 Participants
|
5 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 fatigue
|
7 Participants
|
7 Participants
|
8 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 fever
|
5 Participants
|
9 Participants
|
5 Participants
|
1 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 flu-like symptoms
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 eosiniphilia
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 mitral valve disease
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 atrial fibrillation
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 atrial fibrillation
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 palpitations
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 pericardial effusion
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 sinus bradycardia
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 sinus tachycardia
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 aspartate aminotransferase increased
|
1 Participants
|
7 Participants
|
8 Participants
|
2 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 aspartate aminotransferase increased
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 blood bilirubin increased
|
2 Participants
|
6 Participants
|
6 Participants
|
1 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 blood bilirubin increased
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 lactate dehydrogenase increased
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 activated partial thromboplastin time prolonged
|
1 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 activated partial thromboplastin time prolonged
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 cardiac troponin I increased
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 cardiac troponin I increased
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 cardiac troponin T increased
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 alanine aminotransferase increased
|
12 Participants
|
13 Participants
|
8 Participants
|
4 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 alanine aminotransferase increased
|
2 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 alkaline phosphatase increased
|
12 Participants
|
11 Participants
|
13 Participants
|
5 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 generalized edema
|
5 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 infusion related reaction
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 injection site reaction
|
3 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 localized edema
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 malaise
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 non-cardiac chest pain
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 non-cardiac chest pain
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 pain at injection site
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 pain
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 hepatic hemorrhage
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 allergic reaction
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 allergic reaction
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 Celiac disease
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 bladder infection
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 bronchial infection
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 enterocolitis infectious
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 enterocolitis infectious
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 eye infection
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 folliculitis
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 gum infection
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 influenza A infection
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 lung infection
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 lung infection
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 papulopustular rash
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 paronychia
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 pleural infection
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 sepsis
|
1 Participants
|
3 Participants
|
4 Participants
|
1 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 sinusitis
|
3 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 skin infection
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 skin infection
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 thrush
|
3 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 tooth infection
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 upper respiratory infection
|
2 Participants
|
5 Participants
|
4 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 upper respiratory infection
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 urinary tract infection
|
1 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 urinary tract infection
|
0 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 wound infection
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 ankle fracture
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 bruising
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 fall
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 fall
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 fracture
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 twisted knee
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 ileal bleed due to tumor invasion
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 postoperative hemorrhage
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 spinal fracture
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 wound complication
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 alkaline phosphatase increased
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 productive cough
|
2 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 pulmonary edema
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 respiratory failure
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 chest pressure with exertion
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 rhinorrhea
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 sore throat
|
1 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 wheezing
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 alopecia
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 bullous dermatitis
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 dry skin
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 hyperhidrosis
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 nail changes
|
0 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 nail discoloration
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 nail loss
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 palmar-plantar erythrodysesthesia syndrome
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 pruritus
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 pruritus
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 rash acneiform
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 rash maculo-papular
|
2 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 creatinine increased
|
6 Participants
|
5 Participants
|
9 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 creatinine increased
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 electrocardiogram QT corrected interval prolonged
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 electrocardiogram QT corrected interval prolonged
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 INR increased
|
4 Participants
|
3 Participants
|
9 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 GGT increased
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 INR increased
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 ammonia increased
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 lipase increased
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 lipase increased
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 lymphocyte count decreased
|
6 Participants
|
7 Participants
|
4 Participants
|
2 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 lymphocyte count decreased
|
18 Participants
|
11 Participants
|
20 Participants
|
8 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 neutrophil count decreased
|
6 Participants
|
1 Participants
|
6 Participants
|
3 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 neutrophil count decreased
|
19 Participants
|
18 Participants
|
11 Participants
|
7 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 platelet count decreased
|
6 Participants
|
5 Participants
|
9 Participants
|
4 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 platelet count decreased
|
23 Participants
|
18 Participants
|
12 Participants
|
7 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 weight loss
|
0 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 white blood cell count decreased
|
6 Participants
|
5 Participants
|
5 Participants
|
2 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 white blood cell count decreased
|
19 Participants
|
17 Participants
|
15 Participants
|
9 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 acidosis
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 anorexia
|
5 Participants
|
5 Participants
|
5 Participants
|
2 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 anorexia
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 dehydration
|
1 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 dehydration
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 hypercalcemia
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 hyperglycemia
|
6 Participants
|
4 Participants
|
5 Participants
|
2 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 hyperglycemia
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 hyperkalemia
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 hyperkalemia
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 hyperlipidemia
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 hypermagnesemia
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 hypermagnesemia
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 hypernatremia
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 hyperuricemia
|
6 Participants
|
5 Participants
|
6 Participants
|
2 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 hyperuricemia
|
2 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 hypoalbuminemia
|
14 Participants
|
6 Participants
|
13 Participants
|
1 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 hypoalbuminemia
|
1 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 hypocalcemia
|
12 Participants
|
6 Participants
|
11 Participants
|
2 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 hypocalcemia
|
3 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 hypoglycemia
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 hypoglycemia
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 hypokalemia
|
5 Participants
|
6 Participants
|
7 Participants
|
2 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 hypokalemia
|
2 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 hyponatremia
|
14 Participants
|
7 Participants
|
11 Participants
|
5 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 hyponatremia
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 hypophosphatemia
|
6 Participants
|
1 Participants
|
4 Participants
|
3 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 hypophosphatemia
|
0 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 arthralgia
|
3 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 back pain
|
4 Participants
|
3 Participants
|
4 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 back pain
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 bone pain
|
3 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 flank pain
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 generalized muscle weakness
|
4 Participants
|
3 Participants
|
4 Participants
|
1 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 joint effusion
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 muscle cramp
|
6 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 muscle weakness lower limb
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 myalgia
|
5 Participants
|
7 Participants
|
2 Participants
|
1 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 neck pain
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 pain in extremity
|
3 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 palpable lump RUE
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 skin pailloma, R hallux
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 disease progression
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 tumor pain
|
9 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 tumor pain
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 concentration impairment
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 dizziness
|
1 Participants
|
5 Participants
|
2 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 dysgeusia
|
8 Participants
|
5 Participants
|
8 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 extrapyramidal disorder
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 headache
|
5 Participants
|
5 Participants
|
3 Participants
|
1 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 plantar sensitivity
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 cerebral hemorrhage
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 neuralgia
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 paresthesia
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 paresthesia (face)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 peripheral sensory neuropathy
|
9 Participants
|
5 Participants
|
10 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 phantom pain
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 presyncope
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 spinal cord compression
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 syncope
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 tremor
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 agitation
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 anxiety
|
3 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 confusion
|
2 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 confusion
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 depression
|
4 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 depression
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 insomnia
|
2 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 irritability
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 acute kidney injury
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 acute kidney injury
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 dysuria
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 hematuria
|
9 Participants
|
3 Participants
|
8 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 proteinuria
|
7 Participants
|
7 Participants
|
7 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 renal calculi
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 urinary frequency
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 urinary incontinence
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 urinary retention
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 urinary tract obstruction
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 genital edema
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 pelvic pain
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 groin pain
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 vaginal hemorrhage
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 allergic rhinitis
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 bronchial obstruction
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 cough
|
5 Participants
|
6 Participants
|
5 Participants
|
2 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 dyspnea
|
12 Participants
|
4 Participants
|
6 Participants
|
3 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 dyspnea
|
3 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 epistaxis
|
6 Participants
|
6 Participants
|
3 Participants
|
3 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 hoarseness
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 hypoxia
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 hypoxia
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 pleural effusion
|
3 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 pleural effusion
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 pneumonitis
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 pneumothorax
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 pneumothorax
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 postnasal drip
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 hypotension
|
1 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 hypotension
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 lymphedema
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 thromboembolic event
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 thromboembolic event
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 peripheral edema
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 muscle "tightness"
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 left hand pain
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 right axillary pain
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 right neck stiffness
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 "frozen thumb"
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 hip pain
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 ankle sprain
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 port site bleed
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 rash maculo-papular
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 skin atrophy
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 rash NOS
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 petechial rash
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 skin ulceration
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 urticaria
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 minor gum transplant
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 hot flashes
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 hypertension
|
3 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 hypertension
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 rash NOS on neck
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 rash NOS on bilateral UE
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 nail bed pain
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 feet peeling
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 leukemia secondary to oncology chemotherapy
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 vaginal cyst
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 febrile neutropenia
|
2 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 anemia
|
11 Participants
|
9 Participants
|
12 Participants
|
9 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 3-5 anemia
|
19 Participants
|
11 Participants
|
12 Participants
|
4 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 laryngeal hemorrhage
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 laryngeal inflammation
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
Grade 1-2 nasal congestion
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Through completion of follow-up (median follow-up 494 days, full range of 5-1500 days).Population: Cancer-related mortality was evaluated only for Cohort 1; therefore, no participants in Cohort 2 were analyzed for this outcome measure. 7 participants in Cohort 1 were not evaluable for this outcome measure.
Outcome measures
| Measure |
Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel
n=75 Participants
* ADI-PEG 20 will be given on Day -7 of Cycle 1 and then on Days 1, 8, and 15 of each subsequent cycle. Cycles are 21 days. ADI-PEG 20 will be given on an outpatient basis at a dose of 36 mg/m2 via intramuscular injection into either the deltoid or gluteal muscle.
* Gemcitabine will be given intravenously at a dose of 600 mg/m2 over 90 minutes on Days 1 and 8 of each cycle. Docetaxel will be given intravenously at a dose of 60 mg/m2 over 60 minutes on Day 8 of each cycle. Patients started on gemcitabine at a dose of 900 mg/m2 or 750 mg/m2 or docetaxel at a dose of 75 mg/m2 per previous protocol version will be allowed to continue at that dose level
* After Cycle 8, patients may continue on ADI-PEG 20 alone (without gemcitabine and docetaxel) upon request.
* Treatment may continue for up to 34 cycles (103 weeks)
|
Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel
* ADI-PEG 20 will be given on Day -7 of Cycle 1 and then on Days 1, 8, and 15 of each subsequent cycle. Cycles are 21 days. ADI-PEG 20 will be given on an outpatient basis at a dose of 36 mg/m2 via intramuscular injection into either the deltoid or gluteal muscle.
* Gemcitabine will be given intravenously at a dose of 600 mg/m2 over 90 minutes on Days 1 and 8 of each cycle. Docetaxel will be given intravenously at a dose of 60 mg/m2 over 60 minutes on Day 8 of each cycle. Patients started on gemcitabine at a dose of 900 mg/m2 or 750 mg/m2 or docetaxel at a dose of 75 mg/m2 per previous protocol version will be allowed to continue at that dose level
* After Cycle 8, patients may continue on ADI-PEG 20 alone (without gemcitabine and docetaxel) upon request.
* Treatment may continue for up to 34 cycles (103 weeks)
|
Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel
* ADI-PEG 20 will be given on Day -7 of Cycle 1 and then on Days 1, 8, and 15 of each subsequent cycle. Cycles are 21 days. ADI-PEG 20 will be given on an outpatient basis at a dose of 36 mg/m2 via intramuscular injection into either the deltoid or gluteal muscle.
* Gemcitabine will be given intravenously at a dose of 900 mg/m2 over 90 minutes on Days 1 and 8 of each cycle. Docetaxel will be given intravenously at a dose of 60 mg/m2 over 60 minutes on Day 8 of each cycle. Patients started on gemcitabine at a dose of 900 mg/m2 or 750 mg/m2 or docetaxel at a dose of 75 mg/m2 per previous protocol version will be allowed to continue at that dose level
* After Cycle 8, patients may continue on ADI-PEG 20 alone (without gemcitabine and docetaxel) upon request.
* Treatment may continue for up to 34 cycles (103 weeks)
|
Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel
* ADI-PEG 20 will be given on Day -7 of Cycle 1 and then on Days 1, 8, and 15 of each subsequent cycle. Cycles are 21 days. ADI-PEG 20 will be given on an outpatient basis at a dose of 36 mg/m2 via intramuscular injection into either the deltoid or gluteal muscle.
* Gemcitabine will be given intravenously at a dose of 600 mg/m2 over 90 minutes on Days 1 and 8 of each cycle. Docetaxel will be given intravenously at a dose of 60 mg/m2 over 60 minutes on Day 8 of each cycle. Patients started on gemcitabine at a dose of 900 mg/m2 or 750 mg/m2 or docetaxel at a dose of 75 mg/m2 per previous protocol version will be allowed to continue at that dose level
* After Cycle 8, patients may continue on ADI-PEG 20 alone (without gemcitabine and docetaxel) upon request.
* Treatment may continue for up to 34 cycles (103 weeks)
|
|---|---|---|---|---|
|
Number of Participants With Cancer-related Mortality (Cohort 1 Only)
|
47 Participants
|
—
|
—
|
—
|
Adverse Events
Cohort 1, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel
Serious events: 14 serious events
Other events: 33 other events
Deaths: 19 deaths
Cohort 1, 750 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel
Serious events: 8 serious events
Other events: 25 other events
Deaths: 15 deaths
Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel
Serious events: 13 serious events
Other events: 24 other events
Deaths: 19 deaths
Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel
Serious events: 5 serious events
Other events: 15 other events
Deaths: 12 deaths
Serious adverse events
| Measure |
Cohort 1, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel
n=33 participants at risk
Patients enrolling to Cohort 1 must be diagnosed with soft tissue sarcoma.
* ADI-PEG 20 will be given on Day -7 of Cycle 1 and then on Days 1, 8, and 15 of each subsequent cycle. Cycles are 21 days. ADI-PEG 20 will be given on an outpatient basis at a dose of 36 mg/m2 via intramuscular injection into either the deltoid or gluteal muscle.
* Gemcitabine will be given intravenously at a dose of 600 mg/m2 over 90 minutes on Days 1 and 8 of each cycle. Docetaxel will be given intravenously at a dose of 60 mg/m2 over 60 minutes on Day 8 of each cycle. Patients started on gemcitabine at a dose of 900 mg/m2 or 750 mg/m2 or docetaxel at a dose of 75 mg/m2 per previous protocol version will be allowed to continue at that dose level
* After Cycle 8, patients may continue on ADI-PEG 20 alone (without gemcitabine and docetaxel) upon request.
* Treatment may continue for up to 34 cycles (103 weeks)
|
Cohort 1, 750 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel
n=25 participants at risk
Patients enrolling to Cohort 1 must be diagnosed with soft tissue sarcoma.
* ADI-PEG 20 will be given on Day -7 of Cycle 1 and then on Days 1, 8, and 15 of each subsequent cycle. Cycles are 21 days. ADI-PEG 20 will be given on an outpatient basis at a dose of 36 mg/m2 via intramuscular injection into either the deltoid or gluteal muscle.
* Gemcitabine will be given intravenously at a dose of 750 mg/m2 over 90 minutes on Days 1 and 8 of each cycle. Docetaxel will be given intravenously at a dose of 60 mg/m2 over 60 minutes on Day 8 of each cycle. Patients started on gemcitabine at a dose of 900 mg/m2 or 750 mg/m2 or docetaxel at a dose of 75 mg/m2 per previous protocol version will be allowed to continue at that dose level
* After Cycle 8, patients may continue on ADI-PEG 20 alone (without gemcitabine and docetaxel) upon request.
* Treatment may continue for up to 34 cycles (103 weeks)
|
Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel
n=24 participants at risk
Patients enrolling to Cohort 1 must be diagnosed with soft tissue sarcoma.
* ADI-PEG 20 will be given on Day -7 of Cycle 1 and then on Days 1, 8, and 15 of each subsequent cycle. Cycles are 21 days. ADI-PEG 20 will be given on an outpatient basis at a dose of 36 mg/m2 via intramuscular injection into either the deltoid or gluteal muscle.
* Gemcitabine will be given intravenously at a dose of 900 mg/m2 over 90 minutes on Days 1 and 8 of each cycle. Docetaxel will be given intravenously at a dose of 60 mg/m2 over 60 minutes on Day 8 of each cycle. Patients started on gemcitabine at a dose of 900 mg/m2 or 750 mg/m2 or docetaxel at a dose of 75 mg/m2 per previous protocol version will be allowed to continue at that dose level
* After Cycle 8, patients may continue on ADI-PEG 20 alone (without gemcitabine and docetaxel) upon request.
* Treatment may continue for up to 34 cycles (103 weeks)
|
Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel
n=15 participants at risk
Patients enrolling to Cohort 2 must be diagnosed with osteosarcoma, Ewing's sarcoma, or small cell lung cancer.
* ADI-PEG 20 will be given on Day -7 of Cycle 1 and then on Days 1, 8, and 15 of each subsequent cycle. Cycles are 21 days. ADI-PEG 20 will be given on an outpatient basis at a dose of 36 mg/m2 via intramuscular injection into either the deltoid or gluteal muscle.
* Gemcitabine will be given intravenously at a dose of 600 mg/m2 over 90 minutes on Days 1 and 8 of each cycle. Docetaxel will be given intravenously at a dose of 60 mg/m2 over 60 minutes on Day 8 of each cycle. Patients started on gemcitabine at a dose of 900 mg/m2 or 750 mg/m2 or docetaxel at a dose of 75 mg/m2 per previous protocol version will be allowed to continue at that dose level
* After Cycle 8, patients may continue on ADI-PEG 20 alone (without gemcitabine and docetaxel) upon request.
* Treatment may continue for up to 34 cycles (103 weeks)
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
3.0%
1/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.2%
1/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
9.1%
3/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
12.0%
3/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.2%
1/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.2%
1/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Cardiac disorders
Mitral Valve Disease
|
3.0%
1/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Cardiac disorders
Pericardial Effusion
|
3.0%
1/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Cardiac disorders
Sinus Tachycardia
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.2%
1/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.2%
1/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.2%
1/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Gastrointestinal disorders
Colonic Perforation
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.2%
1/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
6.1%
2/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Gastrointestinal disorders
Typhlitis
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.2%
1/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Gastrointestinal disorders
Upper GI Hemorrhage
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
General disorders
Death NOS
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
General disorders
Fever
|
3.0%
1/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.2%
1/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Hepatobiliary disorders
Hepatic Hemorrhage
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.2%
1/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Infections and infestations
Enterocolitis Infectious
|
3.0%
1/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Infections and infestations
Lung Infection
|
3.0%
1/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
8.3%
2/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Infections and infestations
Other
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Infections and infestations
Sepsis
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
12.0%
3/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
16.7%
4/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Infections and infestations
Skin Infection
|
3.0%
1/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
8.3%
2/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Infections and infestations
Upper Respiratory Infection
|
6.1%
2/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Injury, poisoning and procedural complications
Other
|
3.0%
1/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Injury, poisoning and procedural complications
Postoperative Hemorrhage
|
3.0%
1/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Injury, poisoning and procedural complications
Spinal Fracture
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.2%
1/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Investigations
Neutrophil Count Decreased
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Investigations
Platelet Count Decreased
|
3.0%
1/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.2%
1/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Disease Progression
|
3.0%
1/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
8.3%
2/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukemia Secondary to Oncology Chemotherapy
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor Hemorrhage
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.2%
1/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor Pain
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.2%
1/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
6.1%
2/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Renal and urinary disorders
Urinary Tract Obstruction
|
3.0%
1/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.2%
1/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial Obstruction
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.2%
1/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusions
|
9.1%
3/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.0%
1/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.2%
1/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Edema
|
3.0%
1/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Skin and subcutaneous tissue disorders
Maculopapular Rash
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Vascular disorders
Thromboembolic Event
|
3.0%
1/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.2%
1/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
Other adverse events
| Measure |
Cohort 1, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel
n=33 participants at risk
Patients enrolling to Cohort 1 must be diagnosed with soft tissue sarcoma.
* ADI-PEG 20 will be given on Day -7 of Cycle 1 and then on Days 1, 8, and 15 of each subsequent cycle. Cycles are 21 days. ADI-PEG 20 will be given on an outpatient basis at a dose of 36 mg/m2 via intramuscular injection into either the deltoid or gluteal muscle.
* Gemcitabine will be given intravenously at a dose of 600 mg/m2 over 90 minutes on Days 1 and 8 of each cycle. Docetaxel will be given intravenously at a dose of 60 mg/m2 over 60 minutes on Day 8 of each cycle. Patients started on gemcitabine at a dose of 900 mg/m2 or 750 mg/m2 or docetaxel at a dose of 75 mg/m2 per previous protocol version will be allowed to continue at that dose level
* After Cycle 8, patients may continue on ADI-PEG 20 alone (without gemcitabine and docetaxel) upon request.
* Treatment may continue for up to 34 cycles (103 weeks)
|
Cohort 1, 750 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel
n=25 participants at risk
Patients enrolling to Cohort 1 must be diagnosed with soft tissue sarcoma.
* ADI-PEG 20 will be given on Day -7 of Cycle 1 and then on Days 1, 8, and 15 of each subsequent cycle. Cycles are 21 days. ADI-PEG 20 will be given on an outpatient basis at a dose of 36 mg/m2 via intramuscular injection into either the deltoid or gluteal muscle.
* Gemcitabine will be given intravenously at a dose of 750 mg/m2 over 90 minutes on Days 1 and 8 of each cycle. Docetaxel will be given intravenously at a dose of 60 mg/m2 over 60 minutes on Day 8 of each cycle. Patients started on gemcitabine at a dose of 900 mg/m2 or 750 mg/m2 or docetaxel at a dose of 75 mg/m2 per previous protocol version will be allowed to continue at that dose level
* After Cycle 8, patients may continue on ADI-PEG 20 alone (without gemcitabine and docetaxel) upon request.
* Treatment may continue for up to 34 cycles (103 weeks)
|
Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel
n=24 participants at risk
Patients enrolling to Cohort 1 must be diagnosed with soft tissue sarcoma.
* ADI-PEG 20 will be given on Day -7 of Cycle 1 and then on Days 1, 8, and 15 of each subsequent cycle. Cycles are 21 days. ADI-PEG 20 will be given on an outpatient basis at a dose of 36 mg/m2 via intramuscular injection into either the deltoid or gluteal muscle.
* Gemcitabine will be given intravenously at a dose of 900 mg/m2 over 90 minutes on Days 1 and 8 of each cycle. Docetaxel will be given intravenously at a dose of 60 mg/m2 over 60 minutes on Day 8 of each cycle. Patients started on gemcitabine at a dose of 900 mg/m2 or 750 mg/m2 or docetaxel at a dose of 75 mg/m2 per previous protocol version will be allowed to continue at that dose level
* After Cycle 8, patients may continue on ADI-PEG 20 alone (without gemcitabine and docetaxel) upon request.
* Treatment may continue for up to 34 cycles (103 weeks)
|
Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel
n=15 participants at risk
Patients enrolling to Cohort 2 must be diagnosed with osteosarcoma, Ewing's sarcoma, or small cell lung cancer.
* ADI-PEG 20 will be given on Day -7 of Cycle 1 and then on Days 1, 8, and 15 of each subsequent cycle. Cycles are 21 days. ADI-PEG 20 will be given on an outpatient basis at a dose of 36 mg/m2 via intramuscular injection into either the deltoid or gluteal muscle.
* Gemcitabine will be given intravenously at a dose of 600 mg/m2 over 90 minutes on Days 1 and 8 of each cycle. Docetaxel will be given intravenously at a dose of 60 mg/m2 over 60 minutes on Day 8 of each cycle. Patients started on gemcitabine at a dose of 900 mg/m2 or 750 mg/m2 or docetaxel at a dose of 75 mg/m2 per previous protocol version will be allowed to continue at that dose level
* After Cycle 8, patients may continue on ADI-PEG 20 alone (without gemcitabine and docetaxel) upon request.
* Treatment may continue for up to 34 cycles (103 weeks)
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
87.9%
29/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
76.0%
19/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
95.8%
23/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
86.7%
13/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Cardiac disorders
Chest Pain - Cardiac
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.2%
1/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Cardiac disorders
Palpitations
|
6.1%
2/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Cardiac disorders
Sinus Bradycardia
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Cardiac disorders
Sinus Tachycardia
|
6.1%
2/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
8.0%
2/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Ear and labyrinth disorders
Ear Pain
|
3.0%
1/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Ear and labyrinth disorders
Vertigo
|
3.0%
1/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
8.3%
2/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Eye disorders
Blurred Vision
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Eye disorders
Cataract
|
3.0%
1/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Eye disorders
Dry Eye
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.2%
1/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Eye disorders
Retinal Tear
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Eye disorders
Watering Eyes
|
3.0%
1/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
8.0%
2/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
8.3%
2/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Gastrointestinal disorders
Abdominal Distention
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Gastrointestinal disorders
Abdominal Pain
|
9.1%
3/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
12.5%
3/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Gastrointestinal disorders
Anal Hemorrhage
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.2%
1/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Gastrointestinal disorders
Anal Mucositis
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.2%
1/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.2%
1/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Gastrointestinal disorders
Colonic Hemorrhage
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.2%
1/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Gastrointestinal disorders
Constipation
|
24.2%
8/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
20.0%
5/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
33.3%
8/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
13.3%
2/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Gastrointestinal disorders
Dental Caries
|
12.1%
4/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Gastrointestinal disorders
Diarrhea
|
30.3%
10/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
32.0%
8/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
37.5%
9/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
13.3%
2/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Gastrointestinal disorders
Dry Mouth
|
3.0%
1/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Gastrointestinal disorders
Dyspepsia
|
12.1%
4/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
8.0%
2/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
12.5%
3/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
13.3%
2/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Gastrointestinal disorders
Dysphagia
|
3.0%
1/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Gastrointestinal disorders
Fecal Incontinence
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.2%
1/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
3.0%
1/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
8.0%
2/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.2%
1/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Gastrointestinal disorders
Lip Pain
|
3.0%
1/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Gastrointestinal disorders
Lower Gastrointestinal Hemorrhage
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Gastrointestinal disorders
Mucositis Oral
|
18.2%
6/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
20.0%
5/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
12.5%
3/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
13.3%
2/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Gastrointestinal disorders
Nausea
|
39.4%
13/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
32.0%
8/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
58.3%
14/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
13.3%
2/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Gastrointestinal disorders
Oral Pain
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Gastrointestinal disorders
Other
|
3.0%
1/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Gastrointestinal disorders
Rectal Hemorrhage
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
6.1%
2/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
8.0%
2/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Gastrointestinal disorders
Vomiting
|
21.2%
7/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
16.0%
4/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
12.5%
3/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
26.7%
4/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
General disorders
Chills
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
General disorders
Edema Face
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
General disorders
Edema Limbs
|
30.3%
10/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
24.0%
6/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
45.8%
11/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
13.3%
2/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
General disorders
Edema Trunk
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.2%
1/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
General disorders
Facial Pain
|
3.0%
1/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
General disorders
Fatigue
|
69.7%
23/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
88.0%
22/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
75.0%
18/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
33.3%
5/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
General disorders
Fever
|
12.1%
4/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
36.0%
9/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
20.8%
5/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
General disorders
Flu-Like Symptoms
|
3.0%
1/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.2%
1/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
General disorders
Generalized Edema
|
15.2%
5/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
General disorders
Infusion Related Reaction
|
3.0%
1/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
General disorders
Injection Site Reaction
|
9.1%
3/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
12.0%
3/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.2%
1/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
General disorders
Localized Edema
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.2%
1/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
General disorders
Malaise
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.2%
1/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
General disorders
Non-Cardiac Chest Pain
|
3.0%
1/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.2%
1/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
General disorders
Other
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
8.0%
2/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
General disorders
Pain
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Immune system disorders
Allergic Reaction
|
12.1%
4/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Immune system disorders
Autoimmune Disorder
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Infections and infestations
Bladder Infection
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.2%
1/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Infections and infestations
Bronchial Infection
|
3.0%
1/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.2%
1/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Infections and infestations
Enterocolitis Infection
|
3.0%
1/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.2%
1/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Infections and infestations
Eye Infection
|
3.0%
1/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Infections and infestations
Folliculitis
|
3.0%
1/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Infections and infestations
Gum Infection
|
3.0%
1/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Infections and infestations
Lung Infection
|
6.1%
2/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Infections and infestations
Papulopustular Rash
|
3.0%
1/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Infections and infestations
Paronychia
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.2%
1/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Infections and infestations
Pleural Infection
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Infections and infestations
Sepsis
|
3.0%
1/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Infections and infestations
Sinusitis
|
9.1%
3/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
8.0%
2/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Infections and infestations
Skin Infection
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.2%
1/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Infections and infestations
Thrush
|
9.1%
3/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.2%
1/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Infections and infestations
Tooth Infection
|
3.0%
1/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Infections and infestations
Upper Respiratory Infection
|
3.0%
1/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
20.0%
5/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
16.7%
4/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Infections and infestations
Urinary Tract Infection
|
3.0%
1/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
12.0%
3/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
20.8%
5/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Infections and infestations
Wound Infection
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.2%
1/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Injury, poisoning and procedural complications
Bruising
|
3.0%
1/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.2%
1/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Injury, poisoning and procedural complications
Fall
|
6.1%
2/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
8.0%
2/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.2%
1/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Injury, poisoning and procedural complications
Fracture
|
6.1%
2/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Injury, poisoning and procedural complications
Other
|
6.1%
2/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Injury, poisoning and procedural complications
Wound Complication
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.2%
1/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Investigations
Activated Partial Thromboplastin Time Prolonged
|
6.1%
2/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
8.0%
2/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
20.8%
5/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Investigations
Alanine Aminotransferase Increased
|
42.4%
14/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
56.0%
14/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
45.8%
11/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
26.7%
4/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Investigations
Alkaline Phosphatase Increased
|
39.4%
13/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
48.0%
12/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
54.2%
13/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
40.0%
6/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Investigations
Aspartate Aminotransferase Increased
|
3.0%
1/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
32.0%
8/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
41.7%
10/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
13.3%
2/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Investigations
Blood Bilirubin Increased
|
6.1%
2/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
24.0%
6/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
29.2%
7/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
13.3%
2/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Investigations
Blood Lactate Dehydrogenase Increased
|
6.1%
2/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.2%
1/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Investigations
Cardiac Troponin I Increased
|
3.0%
1/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
8.0%
2/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.2%
1/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Investigations
Cardiac Troponin T Increased
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.2%
1/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Investigations
Creatinine Increased
|
21.2%
7/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
20.0%
5/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
37.5%
9/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Investigations
Electrocardiogram QT Corrected Interval Prolonged
|
3.0%
1/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Investigations
GGT Increased
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Investigations
INR Increased
|
12.1%
4/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
16.0%
4/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
50.0%
12/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Investigations
Lipase Increased
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
8.3%
2/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Investigations
Lymphocyte Count Decreased
|
72.7%
24/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
72.0%
18/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
100.0%
24/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
66.7%
10/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Investigations
Neutrophil Count Decreased
|
75.8%
25/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
76.0%
19/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
70.8%
17/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
66.7%
10/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Investigations
Other
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Investigations
Platelet Count Decreased
|
84.8%
28/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
92.0%
23/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
87.5%
21/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
73.3%
11/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Investigations
Weight Loss
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
12.0%
3/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
13.3%
2/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Investigations
White Blood Cell Decreased
|
75.8%
25/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
88.0%
22/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
83.3%
20/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
73.3%
11/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.2%
1/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Metabolism and nutrition disorders
Anorexia
|
15.2%
5/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
24.0%
6/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
25.0%
6/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
13.3%
2/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.0%
1/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
20.0%
5/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
8.3%
2/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
3.0%
1/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
8.0%
2/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.2%
1/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
18.2%
6/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
20.0%
5/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
29.2%
7/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
13.3%
2/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
3.0%
1/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.2%
1/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
13.3%
2/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Metabolism and nutrition disorders
Hyperlipidemia
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.2%
1/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
8.3%
2/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
3.0%
1/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.2%
1/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
24.2%
8/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
20.0%
5/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
41.7%
10/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
13.3%
2/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
45.5%
15/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
32.0%
8/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
62.5%
15/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
20.0%
3/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
45.5%
15/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
28.0%
7/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
50.0%
12/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
26.7%
4/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
3.0%
1/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
16.7%
4/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
21.2%
7/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
28.0%
7/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
41.7%
10/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
20.0%
3/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
42.4%
14/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
28.0%
7/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
50.0%
12/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
33.3%
5/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
18.2%
6/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
16.0%
4/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
25.0%
6/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
20.0%
3/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.1%
3/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
12.0%
3/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
8.3%
2/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
12.1%
4/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
16.0%
4/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
16.7%
4/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
9.1%
3/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
8.0%
2/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
12.5%
3/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
13.3%
2/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
3.0%
1/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
12.1%
4/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
12.0%
3/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.2%
1/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Musculoskeletal and connective tissue disorders
Joint Effusion
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.2%
1/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Musculoskeletal and connective tissue disorders
Muscle Cramp
|
18.2%
6/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
8.0%
2/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Nervous system disorders
Other
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
8.0%
2/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness Lower Limb
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
15.2%
5/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
28.0%
7/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
8.3%
2/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Musculoskeletal and connective tissue disorders
Other
|
6.1%
2/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
16.0%
4/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
9.1%
3/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
8.0%
2/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.2%
1/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Other
|
9.1%
3/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor Pain
|
27.3%
9/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
12.0%
3/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
13.3%
2/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Nervous system disorders
Concentration Impairment
|
3.0%
1/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Nervous system disorders
Dizziness
|
3.0%
1/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
20.0%
5/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
8.3%
2/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Nervous system disorders
Dysgeusia
|
24.2%
8/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
20.0%
5/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
33.3%
8/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Nervous system disorders
Extrapyramidal Disorder
|
3.0%
1/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Nervous system disorders
Headache
|
15.2%
5/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
20.0%
5/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
12.5%
3/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Nervous system disorders
Neuralgia
|
3.0%
1/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
8.3%
2/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Nervous system disorders
Paresthesia
|
6.1%
2/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
8.0%
2/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
27.3%
9/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
20.0%
5/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
41.7%
10/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Nervous system disorders
Phantom Pain
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.2%
1/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Nervous system disorders
Presyncope
|
6.1%
2/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
8.3%
2/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Nervous system disorders
Spinal Cord Compression
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Nervous system disorders
Syncope
|
6.1%
2/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Nervous system disorders
Tremor
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.2%
1/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Psychiatric disorders
Agitation
|
3.0%
1/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Psychiatric disorders
Anxiety
|
9.1%
3/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
8.0%
2/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Psychiatric disorders
Confusion
|
9.1%
3/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
8.0%
2/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Psychiatric disorders
Depression
|
15.2%
5/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Psychiatric disorders
Insomnia
|
6.1%
2/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
12.0%
3/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
8.3%
2/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.2%
1/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Renal and urinary disorders
Dysuria
|
3.0%
1/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
8.0%
2/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Renal and urinary disorders
Hematuria
|
27.3%
9/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
12.0%
3/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
33.3%
8/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Renal and urinary disorders
Proteinuria
|
21.2%
7/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
28.0%
7/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
29.2%
7/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Renal and urinary disorders
Renal Calculi
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Renal and urinary disorders
Urinary Frequency
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Renal and urinary disorders
Urinary Incontinence
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Renal and urinary disorders
Urinary Retention
|
3.0%
1/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Reproductive system and breast disorders
Genital Edema
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.2%
1/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Reproductive system and breast disorders
Other
|
3.0%
1/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Reproductive system and breast disorders
Pelvic Pain
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.2%
1/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Reproductive system and breast disorders
Vaginal Hemorrhage
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
|
3.0%
1/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
8.0%
2/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.2%
5/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
24.0%
6/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
20.8%
5/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
13.3%
2/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
45.5%
15/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
20.0%
5/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
25.0%
6/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
20.0%
3/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
18.2%
6/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
24.0%
6/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
12.5%
3/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
20.0%
3/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
3.0%
1/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.2%
1/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.0%
1/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.2%
1/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal Hemorrhage
|
3.0%
1/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal Inflammation
|
3.0%
1/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
3.0%
1/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Respiratory, thoracic and mediastinal disorders
Other
|
3.0%
1/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Vascular disorders
Hypotension
|
3.0%
1/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
16.0%
4/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
12.5%
3/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
6.1%
2/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
12.5%
3/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
13.3%
2/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.2%
1/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal Drip
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.2%
1/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
6.1%
2/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
8.0%
2/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.2%
1/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Edema
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
6.1%
2/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
8.0%
2/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
3.0%
1/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
12.0%
3/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.2%
1/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
3.0%
1/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.2%
1/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.1%
2/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
8.0%
2/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.2%
1/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Skin and subcutaneous tissue disorders
Bullous Dermatitis
|
3.0%
1/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.2%
1/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.2%
1/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Skin and subcutaneous tissue disorders
Nail Changes
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
16.7%
4/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Skin and subcutaneous tissue disorders
Nail Discoloration
|
3.0%
1/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Skin and subcutaneous tissue disorders
Nail Loss
|
3.0%
1/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.2%
1/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Skin and subcutaneous tissue disorders
Other
|
6.1%
2/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
12.0%
3/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Skin and subcutaneous tissue disorders
Palmar-Plantar Erythrodysethesia Syndrome
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.2%
1/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.0%
1/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
8.0%
2/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.2%
1/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Skin and subcutaneous tissue disorders
Rash Acneiform
|
3.0%
1/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
8.3%
2/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-papular
|
6.1%
2/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.2%
1/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
26.7%
4/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Skin and subcutaneous tissue disorders
Skin Atrophy
|
3.0%
1/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
3.0%
1/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
3.0%
1/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Surgical and medical procedures
Other
|
6.1%
2/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Vascular disorders
Hot Flashes
|
3.0%
1/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Vascular disorders
Hypertension
|
12.1%
4/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
12.0%
3/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
8.3%
2/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Vascular disorders
Lymphedema
|
3.0%
1/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Vascular disorders
Other
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.0%
1/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
|
Vascular disorders
Thromboembolic Event
|
0.00%
0/33 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
12.0%
3/25 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
4.2%
1/24 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. The range of collection was 35 to 870 days, with a median following time of 87 days. All-cause mortality was collected from start of treatment through completion of follow-up. The range of collection was 5 to 1500 days, with a median follow-up time of 494 days.
|
Additional Information
Mia Weiss, M.D.
Washington University School of Medicine
Phone: 314-362-5737
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place