Trial Outcomes & Findings for Comparison of Radiation Therapy Regimens in Combination With Chemotherapy in Treating Young Patients With Newly Diagnosed Standard-Risk Medulloblastoma (NCT NCT00085735)
NCT ID: NCT00085735
Last Updated: 2025-01-14
Results Overview
EFS was defined as the time interval from date of study entry to date of disease progression, disease recurrence, second malignant neoplasm or death from any cause, whichever occurs first, or to the date of last follow-up for patients without events. EFS was estimated using the method of Kaplan and Meier. 3-year estimates are reported with 95% confidence intervals (CI's).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
549 participants
Primary outcome timeframe
Assessed at 3 years
Results posted on
2025-01-14
Participant Flow
Participants 3-21 years of age were recruited at Children's Oncology Group institutions worldwide and at sites affiliated with the Dutch Childhood Oncology Group. The first patient was enrolled on April 30, 2004 and the last patient was enrolled on January 6, 2014.
Patients were randomized to receive a smaller volume boost (radiation to tumor bed)(IFRT) or standard volume boost (radiation to the entire posterior fossa) (PFRT).Patients 3-7 years of age were also randomized to receive reduced-dose craniospinal radiation (LDCSI) or standard-dose craniospinal radiation (SDCSI).Patients 8 and older received SDCSI.
Participant milestones
| Measure |
Arm I (3-7 Yrs of Age, LDCSI, IFRT)
Patients 3-7 years of age, LDCSI, IFRT
|
Arm II (3-7 Yrs of Age, LDCSI, PFRT)
Patients 3-7 years of age, LDCSI, PFRT
|
Arm III (3-7 Yrs of Age, SDCSI, IFRT)
Patients 3-7 years of age, SDCSI, IFRT
|
Arm IV (3-7 Yrs of Age, SDCSI, PFRT)
Patients 3-7 years of age, SDCSI, PFRT
|
Arm V (8-21 Yrs of Age, SDCSI, IFRT)
Patients 8-21 years of age, SDCSI, IFRT
|
Arm VI (8-21 Yrs of Age, SDCSI, PFRT)
Patients 8-21 yrs of age, SDCSI, PFRT
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
64
|
64
|
63
|
65
|
147
|
146
|
|
Overall Study
COMPLETED
|
52
|
54
|
46
|
46
|
105
|
115
|
|
Overall Study
NOT COMPLETED
|
12
|
10
|
17
|
19
|
42
|
31
|
Reasons for withdrawal
| Measure |
Arm I (3-7 Yrs of Age, LDCSI, IFRT)
Patients 3-7 years of age, LDCSI, IFRT
|
Arm II (3-7 Yrs of Age, LDCSI, PFRT)
Patients 3-7 years of age, LDCSI, PFRT
|
Arm III (3-7 Yrs of Age, SDCSI, IFRT)
Patients 3-7 years of age, SDCSI, IFRT
|
Arm IV (3-7 Yrs of Age, SDCSI, PFRT)
Patients 3-7 years of age, SDCSI, PFRT
|
Arm V (8-21 Yrs of Age, SDCSI, IFRT)
Patients 8-21 years of age, SDCSI, IFRT
|
Arm VI (8-21 Yrs of Age, SDCSI, PFRT)
Patients 8-21 yrs of age, SDCSI, PFRT
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Lack of Efficacy
|
2
|
4
|
6
|
3
|
4
|
3
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
1
|
0
|
|
Overall Study
Physician Decision
|
2
|
3
|
2
|
3
|
11
|
8
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
4
|
5
|
7
|
8
|
|
Overall Study
Patient ineligible
|
1
|
0
|
3
|
7
|
17
|
8
|
|
Overall Study
Excess residual disease
|
2
|
2
|
1
|
1
|
1
|
4
|
|
Overall Study
Reason not documented
|
1
|
0
|
1
|
0
|
1
|
0
|
|
Overall Study
Pt transferred to inst w/out study open
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Comparison of Radiation Therapy Regimens in Combination With Chemotherapy in Treating Young Patients With Newly Diagnosed Standard-Risk Medulloblastoma
Baseline characteristics by cohort
| Measure |
Arm I (3-7 Years of Age, LDCSI, IFRT)
n=63 Participants
Eligible patients 3-7 yrs of age, LDCSI, IFRT
|
Arm II (3-7 Years of Age, LDCSI, PFRT)
n=64 Participants
Eligible patients 3-7 yrs of age, LDCSI, PFRT
|
Arm III (3-7 Years of Age, SDCSI, IFRT)
n=60 Participants
Eligible patients 3-7 yrs of age, SDCSI, IFRT
|
Arm IV (3-7 Years of Age, SDCSI, PFRT)
n=58 Participants
Eligible patients 3-7 yrs of age, SDCSI, PFRT
|
Arm V (8-21 Years of Age, SDCSI, IFRT)
n=130 Participants
Eligible patients 8-21 yrs of age, SDCSI, IFRT
|
Arm VI (8-21 Years of Age, SDCSI, PFRT)
n=138 Participants
Eligible patients 8-21 yrs of age, SDCSI, PFRT
|
Total
n=513 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
63 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
58 Participants
n=4 Participants
|
120 Participants
n=21 Participants
|
128 Participants
n=8 Participants
|
493 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
20 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Age, Continuous
|
5.9 years
n=5 Participants
|
5.9 years
n=7 Participants
|
5.9 years
n=5 Participants
|
5.4 years
n=4 Participants
|
12.4 years
n=21 Participants
|
11.8 years
n=8 Participants
|
8.3 years
n=8 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
53 Participants
n=21 Participants
|
51 Participants
n=8 Participants
|
184 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
77 Participants
n=21 Participants
|
87 Participants
n=8 Participants
|
329 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
23 Participants
n=8 Participants
|
87 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
51 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
110 Participants
n=21 Participants
|
109 Participants
n=8 Participants
|
410 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
16 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
10 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
41 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
50 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
108 Participants
n=21 Participants
|
120 Participants
n=8 Participants
|
420 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
35 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Assessed at 3 yearsPopulation: Per protocol only eligible \& evaluable pts are included. Pts with anaplastic histology or disseminated/excess residual disease were not evaluable (NE). 26/23 IFRT/PFRT pts were NE, leaving 227 vs 237 for this comparison. The LD/SD CSI comparison was done only in pts 3-7 yrs of age. 11/8 LD/SDCSI pts were NE, leaving 116 vs 110 for this comparison.
EFS was defined as the time interval from date of study entry to date of disease progression, disease recurrence, second malignant neoplasm or death from any cause, whichever occurs first, or to the date of last follow-up for patients without events. EFS was estimated using the method of Kaplan and Meier. 3-year estimates are reported with 95% confidence intervals (CI's).
Outcome measures
| Measure |
Low-dose Craniospinal Radiation (LDSCI)
n=116 Participants
Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the LDCSI arms (Arms I and II)
|
Standard-dose Craniospinal Radiation (SDCSI)
n=110 Participants
Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the SDCSI arms (Arms III and IV)
|
Involved Field Radiation (IFRT)
n=227 Participants
Includes eligible patients without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the IFRT arms (I, III, V).
|
Posterior Fossa Radiation (PFRT)
n=237 Participants
Includes eligible patients without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the PFRT arms (II, IV, VI).
|
|---|---|---|---|---|
|
Event-free Survival (EFS)
LDCSI vs SDCSI
|
76.3 probability of 3 year EFS
Interval 67.9 to 84.7
|
84.9 probability of 3 year EFS
Interval 77.6 to 92.2
|
—
|
—
|
|
Event-free Survival (EFS)
IFRT vs PFRT
|
—
|
—
|
85.8 probability of 3 year EFS
Interval 81.1 to 90.5
|
85.8 probability of 3 year EFS
Interval 81.1 to 90.5
|
PRIMARY outcome
Timeframe: 3 yearsPopulation: Per protocol only eligible \& evaluable pts were included.Pts with anaplastic histology or disseminated/excess residual disease were not evaluable (NE). 26/23 IFRT/PFRT pts were NE, leaving 227 vs 237 for this comparison. The LD/SD CSI comparison was done only in pts 3-7 yrs of age. 11/8 LD/SDCSI pts were NE, leaving 116 vs 110 for this comparison.
OS was defined as the time interval from date of study entry to date of death from any cause or to the date of last follow-up for survivors. OS was estimated using the method of Kaplan and Meier. 3-year estimates are reported with 95% CI's. For purposes of this analysis, arms I, III and V (involved field radiation therapy \[IFRT\]) are combined and compared to arms II, IV and VI (posterior fossa irradiation \[PFRT\]).
Outcome measures
| Measure |
Low-dose Craniospinal Radiation (LDSCI)
n=116 Participants
Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the LDCSI arms (Arms I and II)
|
Standard-dose Craniospinal Radiation (SDCSI)
n=110 Participants
Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the SDCSI arms (Arms III and IV)
|
Involved Field Radiation (IFRT)
n=227 Participants
Includes eligible patients without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the IFRT arms (I, III, V).
|
Posterior Fossa Radiation (PFRT)
n=237 Participants
Includes eligible patients without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the PFRT arms (II, IV, VI).
|
|---|---|---|---|---|
|
Overall Survival (OS)
IFRT vs PFRT
|
—
|
—
|
90.3 Probability of 3 yr OS rate
Interval 86.2 to 94.4
|
93.3 Probability of 3 yr OS rate
Interval 90.0 to 96.6
|
|
Overall Survival (OS)
LDCSI vs SDCSI
|
85.5 Probability of 3 yr OS rate
Interval 78.4 to 92.6
|
90.4 Probability of 3 yr OS rate
Interval 84.3 to 96.5
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: Eligible and evaluable patients 3-21 yrs of age are included. Patients with anaplastic histology or disseminated/excess residual disease were not evaluable (NE). Arms I/III/V \[IFRT\] are combined \& arms II/IV/VI \[PFRT\] are combined. 26 \& 23 IFRT \& PFRT pts were NE and were excluded, leaving 227 and 237 eligible and evaluable pts.
LPF failure was defined as tumor recurrence/progression within the tumor bed. The cumulative incidence (CI) of LPF failure was estimated; 3-year estimates were reported with 95% confidence intervals. Patients with other failure types (e.g., NPF) and with other events prior to LPF failure (e.g., death, second malignancy) were considered as having competing events.
Outcome measures
| Measure |
Low-dose Craniospinal Radiation (LDSCI)
n=227 Participants
Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the LDCSI arms (Arms I and II)
|
Standard-dose Craniospinal Radiation (SDCSI)
n=237 Participants
Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the SDCSI arms (Arms III and IV)
|
Involved Field Radiation (IFRT)
Includes eligible patients without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the IFRT arms (I, III, V).
|
Posterior Fossa Radiation (PFRT)
Includes eligible patients without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the PFRT arms (II, IV, VI).
|
|---|---|---|---|---|
|
Local Posterior Fossa (LPF) Failure Rate
|
1.4 percentage 3 yr cumulative incidence
Interval 0.0 to 2.89
|
2.7 percentage 3 yr cumulative incidence
Interval 0.6 to 4.9
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: Eligible and evaluable patients 3-21 yrs of age are included. Patients with anaplastic histology or disseminated/excess residual disease were not evaluable (NE). Arms I/III/V \[IFRT\] are combined \& arms II/IV/VI \[PFRT\] are combined. 26 \& 23 IFRT \& PFRT pts were NE and were excluded, leaving 227 and 237 eligible and evaluable pts.
NLPF failure was defined as tumor recurrence/progression outside the radiation therapy clinical target volume boost (CTV-boost) but within the posterior fossa CTV (CTV-PF). The cumulative incidence (CI) of NLPF failure was estimated; 3-year estimates were reported with 95% confidence intervals. Patients with other failure types (e.g., NPF, LPF) and with other events prior to NLPF failure (e.g., death, second malignancy) were considered as having competing events.
Outcome measures
| Measure |
Low-dose Craniospinal Radiation (LDSCI)
n=227 Participants
Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the LDCSI arms (Arms I and II)
|
Standard-dose Craniospinal Radiation (SDCSI)
n=237 Participants
Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the SDCSI arms (Arms III and IV)
|
Involved Field Radiation (IFRT)
Includes eligible patients without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the IFRT arms (I, III, V).
|
Posterior Fossa Radiation (PFRT)
Includes eligible patients without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the PFRT arms (II, IV, VI).
|
|---|---|---|---|---|
|
Non-local Posterior Fossa (NLPF) Failure Rate
|
6.9 Percentage of 3 yr cumulative incidence
Interval 3.5 to 10.3
|
2.7 Percentage of 3 yr cumulative incidence
Interval 0.6 to 4.8
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: Eligible and evaluable patients 3-21 yrs of age are included. Patients with anaplastic histology or disseminated/excess residual disease were not evaluable (NE). Arms I/III/V \[IFRT\] are combined \& arms II/IV/VI \[PFRT\] are combined. 26 \& 23 IFRT \& PFRT pts were NE and were excluded, leaving 227 and 237 eligible and evaluable pts.
NPF failure was defined as tumor recurrence within the neuroaxis but outside the radiation therapy clinical target volume (CTV). The cumulative incidence (CI) of NPF failure was estimated; 3-year estimates were reported with 95% confidence intervals. Patients with other failure types (e.g., LPF failure) and with other events prior to NPF failure (e.g., death, second malignancy) were considered as having competing events.
Outcome measures
| Measure |
Low-dose Craniospinal Radiation (LDSCI)
n=227 Participants
Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the LDCSI arms (Arms I and II)
|
Standard-dose Craniospinal Radiation (SDCSI)
n=237 Participants
Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the SDCSI arms (Arms III and IV)
|
Involved Field Radiation (IFRT)
Includes eligible patients without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the IFRT arms (I, III, V).
|
Posterior Fossa Radiation (PFRT)
Includes eligible patients without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the PFRT arms (II, IV, VI).
|
|---|---|---|---|---|
|
Non-posterior Fossa (NPF) Failure Rate
|
5.1 Percentage of 3 yr cumulative incidence
Interval 2.2 to 8.0
|
6.2 Percentage of 3 yr cumulative incidence
Interval 3.0 to 9.4
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Only eligible \& evaluable pts 3-7 years of age were included. Pts with anaplastic histology or disseminated/excess residual disease were not evaluable (NE). 11 and 8 LDSCI and SDCSI pts were NE, respectively, leaving 116 vs 110 for this comparison. Of these, 89 LDSCI and 79 SDCSI pts had post-treatment TSH values available and were included.
Post-treatment endocrine function was measured by laboratory assessment of the thyroid stimulating hormone (TSH). The mean TSH will be reported.
Outcome measures
| Measure |
Low-dose Craniospinal Radiation (LDSCI)
n=89 Participants
Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the LDCSI arms (Arms I and II)
|
Standard-dose Craniospinal Radiation (SDCSI)
n=79 Participants
Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the SDCSI arms (Arms III and IV)
|
Involved Field Radiation (IFRT)
Includes eligible patients without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the IFRT arms (I, III, V).
|
Posterior Fossa Radiation (PFRT)
Includes eligible patients without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the PFRT arms (II, IV, VI).
|
|---|---|---|---|---|
|
Post-treatment Endocrine Function by CSI Group
|
5.3 uU/ml
Standard Deviation 5.6
|
6.1 uU/ml
Standard Deviation 5.3
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Only eligible \& evaluable pts 3-7 years of age are included since only younger pts were randomized to either LD or SD CSI. 11 and 8 LDCSI and SDCSI pts respectively were not evaluable due to anaplastic disease or excess residual/disseminated disease, leaving 116 vs 110 patients for this analysis.
Proportions of patients with grade 3+ hearing loss after the completion of therapy will be calculated and reported separately for low dose craniospinal irradiation (LDCSI) versus (vs.) standard dose craniospinal irradiation (SDCSI) patients. Eligible and evaluable patients 3-7 years of age will be used.
Outcome measures
| Measure |
Low-dose Craniospinal Radiation (LDSCI)
n=116 Participants
Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the LDCSI arms (Arms I and II)
|
Standard-dose Craniospinal Radiation (SDCSI)
n=110 Participants
Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the SDCSI arms (Arms III and IV)
|
Involved Field Radiation (IFRT)
Includes eligible patients without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the IFRT arms (I, III, V).
|
Posterior Fossa Radiation (PFRT)
Includes eligible patients without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the PFRT arms (II, IV, VI).
|
|---|---|---|---|---|
|
Post-treatment Grade 3+ Hearing Loss as Measured by Common Terminology Criteria for Adverse Events (CTCAE) Version (v)4
|
11 Percentage of pts with g3+ hearing loss
|
11 Percentage of pts with g3+ hearing loss
|
—
|
—
|
SECONDARY outcome
Timeframe: 4 -15 months post diagnosisPopulation: Only eligible \& evaluable patients 3-7 years of age with FSIQ observations within time window were included.
Post-treatment neurocognitive function was assessed. Full-scale IQ (FSIQ) is a representative measurement for neurocognitive function. FSIQ was measured by IQ tests. Assessments within the time window, from eligible and evaluable patients are reported. The time window is 4-15 months post diagnosis, only the assessments before progression date were reported. The Range of FSIQ is 50-150. A higher FSIQ is better.
Outcome measures
| Measure |
Low-dose Craniospinal Radiation (LDSCI)
n=56 Participants
Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the LDCSI arms (Arms I and II)
|
Standard-dose Craniospinal Radiation (SDCSI)
n=52 Participants
Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the SDCSI arms (Arms III and IV)
|
Involved Field Radiation (IFRT)
Includes eligible patients without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the IFRT arms (I, III, V).
|
Posterior Fossa Radiation (PFRT)
Includes eligible patients without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the PFRT arms (II, IV, VI).
|
|---|---|---|---|---|
|
Post-treatment Neurocognitive Function as Measured by the Estimated Full-scale IQ (FSIQ) by CSI Group Within Time Window 1 (4 - 15 Months Post Diagnosis).
|
93.8 Scores on a scale
Standard Deviation 14.4
|
96.2 Scores on a scale
Standard Deviation 15.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 27 - 48 months post diagnosisPopulation: Only eligible \& evaluable patients 3-7 years of age with FSIQ observations within time window were included.
Post-treatment neurocognitive function was assessed. Full-scale IQ (FSIQ) is a representative measurement for neurocognitive function. FSIQ was measured by IQ tests. Assessments within the time window, from eligible and evaluable patients are reported. The time window is 27-48 months post diagnosis, only the assessments before progression date were reported. The range of FSIQ is 50 - 150. A higher FSIQ is better.
Outcome measures
| Measure |
Low-dose Craniospinal Radiation (LDSCI)
n=35 Participants
Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the LDCSI arms (Arms I and II)
|
Standard-dose Craniospinal Radiation (SDCSI)
n=34 Participants
Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the SDCSI arms (Arms III and IV)
|
Involved Field Radiation (IFRT)
Includes eligible patients without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the IFRT arms (I, III, V).
|
Posterior Fossa Radiation (PFRT)
Includes eligible patients without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the PFRT arms (II, IV, VI).
|
|---|---|---|---|---|
|
Post-treatment Neurocognitive Function as Measured by the Estimated Full-scale IQ (FSIQ) by CSI Group Within Time Window 2 (27 - 48 Months Post Diagnosis)
|
92.2 Scores on a scale
Standard Deviation 12.5
|
90.5 Scores on a scale
Standard Deviation 13.3
|
—
|
—
|
SECONDARY outcome
Timeframe: 49 - 72 months post diagnosisPopulation: Eligible and evaluable patients are reported.
Post-treatment neurocognitive function was assessed. Full-scale IQ (FSIQ) is a representative measurement for neurocognitive function. FSIQ was measured by IQ tests. Assessments within the time window, from eligible and evaluable patients are reported. The time window is 49-72 months post diagnosis, only the assessments before progression date were reported. The Range of FSIQ is 50-150. A higher FSIQ is better.
Outcome measures
| Measure |
Low-dose Craniospinal Radiation (LDSCI)
n=23 Participants
Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the LDCSI arms (Arms I and II)
|
Standard-dose Craniospinal Radiation (SDCSI)
n=22 Participants
Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the SDCSI arms (Arms III and IV)
|
Involved Field Radiation (IFRT)
Includes eligible patients without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the IFRT arms (I, III, V).
|
Posterior Fossa Radiation (PFRT)
Includes eligible patients without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the PFRT arms (II, IV, VI).
|
|---|---|---|---|---|
|
Post-treatment Neurocognitive Function as Measured by the Estimated Full-scale IQ (FSIQ) by CSI Group Within Time Window 3 (49 - 72 Months Post Diagnosis)
|
90.5 Scores on a scale
Standard Deviation 15.4
|
86.4 Scores on a scale
Standard Deviation 13.5
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Eligible \& evaluable pts were included. Pts with anaplastic histology or disseminated/excess residual disease were not evaluable(NE). 26/23 IFRT/PFRT pts were NE, leaving 227 vs 237 eligible/evaluable pts. However some pts (28/22) weren't followed for at least 1-yr post-off tx (e.g., withdrew consent for FU or died), leaving 199 IFRT/215 PFRT pts.
Proportions of patients with grade 3+ hearing impairment as assessed by CTCAE v4 at 1-year post treatment were calculated.
Outcome measures
| Measure |
Low-dose Craniospinal Radiation (LDSCI)
n=199 Participants
Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the LDCSI arms (Arms I and II)
|
Standard-dose Craniospinal Radiation (SDCSI)
n=215 Participants
Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the SDCSI arms (Arms III and IV)
|
Involved Field Radiation (IFRT)
Includes eligible patients without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the IFRT arms (I, III, V).
|
Posterior Fossa Radiation (PFRT)
Includes eligible patients without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the PFRT arms (II, IV, VI).
|
|---|---|---|---|---|
|
Incidence of Grade 3+ Hearing Loss at 1-year Post Treatment as Assessed by CTCAE v4
|
8 Percentage of pts with g3+ hearing loss
|
8 Percentage of pts with g3+ hearing loss
|
—
|
—
|
SECONDARY outcome
Timeframe: Post-treatment up to 3 yearsPopulation: Only eligible \& evaluable patients 3-7 years of age were included. Patients with anaplastic histology or disseminated/excess residual disease were not evaluable (NE). Availability of growth hormone stimulation test results were very limited. Only 3 out of 464 eligible and evaluable patients had this data available (2 PFRT patients and 1 IFRT).
Endocrine dysfunction was assessed by growth hormone stimulation (GHS) tests. We report the percentage of patients with abnormal growth hormone stimulation tests.
Outcome measures
| Measure |
Low-dose Craniospinal Radiation (LDSCI)
n=1 Participants
Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the LDCSI arms (Arms I and II)
|
Standard-dose Craniospinal Radiation (SDCSI)
n=2 Participants
Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the SDCSI arms (Arms III and IV)
|
Involved Field Radiation (IFRT)
Includes eligible patients without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the IFRT arms (I, III, V).
|
Posterior Fossa Radiation (PFRT)
Includes eligible patients without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the PFRT arms (II, IV, VI).
|
|---|---|---|---|---|
|
Incidence of Endocrine Dysfunction as Measured by Growth Hormone Stimulation Tests at the Time of Completion of Therapy by Radiotherapy (RT) Group
|
0.0 Percentage of patients
Interval 0.0 to 95.0
|
50.0 Percentage of patients
Interval 2.5 to 97.5
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: 355 patients were classified into one of the medulloblastoma subgroups by methylation arrays and included in this analysis; 74 were Group 3 medulloblastoma, 154 were Group 4 medulloblastoma, 64 were SHH medulloblastoma, and 63 were WNT medulloblastoma patients.
OS was defined as the time interval from date of study entry to date of death from any cause or to date of last contact for survivors. OS was estimated using the method of Kaplan and Meier. 3-year estimates are reported with 95% CI's.
Outcome measures
| Measure |
Low-dose Craniospinal Radiation (LDSCI)
n=74 Participants
Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the LDCSI arms (Arms I and II)
|
Standard-dose Craniospinal Radiation (SDCSI)
n=154 Participants
Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the SDCSI arms (Arms III and IV)
|
Involved Field Radiation (IFRT)
n=64 Participants
Includes eligible patients without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the IFRT arms (I, III, V).
|
Posterior Fossa Radiation (PFRT)
n=63 Participants
Includes eligible patients without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the PFRT arms (II, IV, VI).
|
|---|---|---|---|---|
|
Overall Survival (OS) by Molecular Subgroup Based on Methylation Arrays
|
76.3 Percent probability of overall survival
Interval 66.5 to 86.1
|
97.3 Percent probability of overall survival
Interval 94.8 to 99.8
|
92.0 Percent probability of overall survival
Interval 85.1 to 98.9
|
98.3 Percent probability of overall survival
Interval 95.0 to 100.0
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: 355 patients were classified into one of the medulloblastoma subgroups by methylation arrays and included in this analysis; 74 were Group 3 medulloblastoma, 154 were Group 4 medulloblastoma, 64 were SHH medulloblastoma, and 63 were WNT medulloblastoma patients.
PFS was defined as the time interval from date of study entry to disease progression, relapse or death due to cancer or to last follow-up. Second malignancies and deaths from causes clearly not associated with tumor progression or recurrence were censored. PFS was estimated using the method of Kaplan and Meier. 3-year estimates are reported with 95% CI's.
Outcome measures
| Measure |
Low-dose Craniospinal Radiation (LDSCI)
n=74 Participants
Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the LDCSI arms (Arms I and II)
|
Standard-dose Craniospinal Radiation (SDCSI)
n=154 Participants
Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the SDCSI arms (Arms III and IV)
|
Involved Field Radiation (IFRT)
n=64 Participants
Includes eligible patients without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the IFRT arms (I, III, V).
|
Posterior Fossa Radiation (PFRT)
n=63 Participants
Includes eligible patients without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the PFRT arms (II, IV, VI).
|
|---|---|---|---|---|
|
Progression-free Survival (PFS) by Molecular Subgroup Based on Methylation Arrays
|
70.6 Percentage probability of PFS
Interval 60.0 to 81.2
|
90.6 Percentage probability of PFS
Interval 85.9 to 95.3
|
90.4 Percentage probability of PFS
Interval 83.1 to 97.7
|
98.4 Percentage probability of PFS
Interval 95.3 to 100.0
|
SECONDARY outcome
Timeframe: 4 - 15 months post diagnosisPopulation: Only eligible \& evaluable patients 3-7 years of age with MI values within time window were included.
Metacognition index (MI) was measured by BRIEF test. Assessments within the time window, from eligible and evaluable patients are reported. If the patient had disease progression, only the assessments before progression date were reported. The MI is a standard T- score, and it ranges from 0 to 100. The higher score reported suggests a higher level of dysfunction.
Outcome measures
| Measure |
Low-dose Craniospinal Radiation (LDSCI)
n=64 Participants
Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the LDCSI arms (Arms I and II)
|
Standard-dose Craniospinal Radiation (SDCSI)
n=53 Participants
Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the SDCSI arms (Arms III and IV)
|
Involved Field Radiation (IFRT)
Includes eligible patients without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the IFRT arms (I, III, V).
|
Posterior Fossa Radiation (PFRT)
Includes eligible patients without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the PFRT arms (II, IV, VI).
|
|---|---|---|---|---|
|
Post-treatment Metacognition Index (MI) on the Behavior Rating Inventory of Executive Function (BRIEF) by CSI Group Within Time Window 1 (4-15 Months Post Diagnosis)
|
50.7 T-score
Standard Deviation 11.1
|
51.3 T-score
Standard Deviation 9.6
|
—
|
—
|
SECONDARY outcome
Timeframe: 27-48 months post diagnosisPopulation: Only eligible \& evaluable patients 3-7 years of age with MI values within time window were included.
Metacognition index (MI) was measured by BRIEF test. Assessments within the time window, from eligible and evaluable patients are reported. If the patient had disease progression, only the assessments before progression date were reported. The MI is a standard T- score, and it ranges from 0 to 100. The higher score reported suggests a higher level of dysfunction.
Outcome measures
| Measure |
Low-dose Craniospinal Radiation (LDSCI)
n=27 Participants
Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the LDCSI arms (Arms I and II)
|
Standard-dose Craniospinal Radiation (SDCSI)
n=27 Participants
Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the SDCSI arms (Arms III and IV)
|
Involved Field Radiation (IFRT)
Includes eligible patients without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the IFRT arms (I, III, V).
|
Posterior Fossa Radiation (PFRT)
Includes eligible patients without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the PFRT arms (II, IV, VI).
|
|---|---|---|---|---|
|
Post-treatment Metacognition Index (MI) on the Behavior Rating Inventory of Executive Function (BRIEF) by CSI Group Within Time Window 2 (27-48 Months Post Diagnosis)
|
51.4 T-score
Standard Deviation 10.6
|
55.0 T-score
Standard Deviation 9.9
|
—
|
—
|
SECONDARY outcome
Timeframe: 49 - 72 months post diagnosisPopulation: Only eligible \& evaluable patients 3-7 years of age with MI values within time window were included.
Metacognition index (MI) was measured by BRIEF test. Assessments within the time window, from eligible and evaluable patients are reported. If the patient had disease progression, only the assessments before progression date were reported. The MI is a standard T- score, and it ranges from 0 to 100. The higher score reported suggests a higher level of dysfunction.
Outcome measures
| Measure |
Low-dose Craniospinal Radiation (LDSCI)
n=21 Participants
Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the LDCSI arms (Arms I and II)
|
Standard-dose Craniospinal Radiation (SDCSI)
n=22 Participants
Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the SDCSI arms (Arms III and IV)
|
Involved Field Radiation (IFRT)
Includes eligible patients without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the IFRT arms (I, III, V).
|
Posterior Fossa Radiation (PFRT)
Includes eligible patients without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the PFRT arms (II, IV, VI).
|
|---|---|---|---|---|
|
Post-treatment Metacognition Index (MI) on the Behavior Rating Inventory of Executive Function (BRIEF) by CSI Group Within Time Window 3 (49 - 72 Months Post Diagnosis)
|
54.1 T-score
Standard Deviation 10.7
|
58.6 T-score
Standard Deviation 11.3
|
—
|
—
|
SECONDARY outcome
Timeframe: 4-15 months post diagnosisPopulation: All eligible and evaluable patients enrolled. Patients removed from treatment prior to the time of neuropsychological assessment (for reasons such as disease progression, death, withdrawal of consent, etc.) will not be included in the denominator to assess the compliance rate.
Compliance rates are calculated to monitor the compliance with long-term quality of life and functional status data submission. A patient will be compliant if the patient has metacognition index score. Compliance rates will be assessed at each of the 3 neurocognitive/quality of life assessment time windows. All eligible and evaluable patients enrolled will be used. Patients removed from treatment prior to the time of neuropsychological assessment (for reasons such as disease progression, death, withdrawal of consent, etc.) will not be included in the denominator to assess the compliance rate. The time window is 4 - 15 months post diagnosis.
Outcome measures
| Measure |
Low-dose Craniospinal Radiation (LDSCI)
n=448 Participants
Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the LDCSI arms (Arms I and II)
|
Standard-dose Craniospinal Radiation (SDCSI)
Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the SDCSI arms (Arms III and IV)
|
Involved Field Radiation (IFRT)
Includes eligible patients without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the IFRT arms (I, III, V).
|
Posterior Fossa Radiation (PFRT)
Includes eligible patients without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the PFRT arms (II, IV, VI).
|
|---|---|---|---|---|
|
Compliance Rates for All Eligible and Evaluable Patients Enrolled Within Time Window 1 (4-15 Months Post Diagnosis)
|
58 Percentage of Participants
Interval 54.0 to 62.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 27-48 months post diagnosisPopulation: All eligible and evaluable patients enrolled. Patients removed from treatment prior to the time of neuropsychological assessment (for reasons such as disease progression, death, withdrawal of consent, etc.) will not be included in the denominator to assess the compliance rate.
Compliance rates are calculated to monitor the compliance with long-term quality of life and functional status data submission. A patient will be compliant if the patient has metacognition index score. Compliance rates will be assessed at each of the 3 neurocognitive/quality of life assessment time windows. All eligible and evaluable patients enrolled will be used. Patients removed from treatment prior to the time of neuropsychological assessment (for reasons such as disease progression, death, withdrawal of consent, etc.) will not be included in the denominator to assess the compliance rate. The time window is 27 - 48 months post diagnosis.
Outcome measures
| Measure |
Low-dose Craniospinal Radiation (LDSCI)
n=395 Participants
Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the LDCSI arms (Arms I and II)
|
Standard-dose Craniospinal Radiation (SDCSI)
Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the SDCSI arms (Arms III and IV)
|
Involved Field Radiation (IFRT)
Includes eligible patients without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the IFRT arms (I, III, V).
|
Posterior Fossa Radiation (PFRT)
Includes eligible patients without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the PFRT arms (II, IV, VI).
|
|---|---|---|---|---|
|
Compliance Rates for All Eligible and Evaluable Patients Enrolled Within Time Window 2 (27-48 Months Post Diagnosis)
|
32 Percentage of Participants
Interval 28.0 to 36.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 49 - 72 months post diagnosisPopulation: All eligible and evaluable patients enrolled. Patients removed from treatment prior to the time of neuropsychological assessment (for reasons such as disease progression, death, withdrawal of consent, etc.) will not be included in the denominator to assess the compliance rate.
Compliance rates are calculated to monitor the compliance with long-term quality of life and functional status data submission. A patient will be compliant if the patient has metacognition index score. Compliance rates will be assessed at each of the 3 neurocognitive/quality of life assessment time windows. All eligible and evaluable patients enrolled will be used. Patients removed from treatment prior to the time of neuropsychological assessment (for reasons such as disease progression, death, withdrawal of consent, etc.) will not be included in the denominator to assess the compliance rate. The time window is 49 - 72 months post diagnosis.
Outcome measures
| Measure |
Low-dose Craniospinal Radiation (LDSCI)
n=131 Participants
Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the LDCSI arms (Arms I and II)
|
Standard-dose Craniospinal Radiation (SDCSI)
Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the SDCSI arms (Arms III and IV)
|
Involved Field Radiation (IFRT)
Includes eligible patients without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the IFRT arms (I, III, V).
|
Posterior Fossa Radiation (PFRT)
Includes eligible patients without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the PFRT arms (II, IV, VI).
|
|---|---|---|---|---|
|
Compliance Rates for All Eligible and Evaluable Patients Enrolled Within Time Window 3 (49 - 72 Months Post Diagnosis)
|
69 Percentage of Participants
Interval 61.0 to 77.0
|
—
|
—
|
—
|
Adverse Events
Arm I (3-7 Years of Age, LDCSI, IFRT)
Serious events: 7 serious events
Other events: 60 other events
Deaths: 0 deaths
Arm II (3-7 Years of Age, LDCSI, PFRT)
Serious events: 7 serious events
Other events: 61 other events
Deaths: 0 deaths
Arm III (3-7 Years of Age, SDCSI, IFRT)
Serious events: 6 serious events
Other events: 55 other events
Deaths: 0 deaths
Arm IV (3-7 Years of Age, SDCSI, PFRT)
Serious events: 3 serious events
Other events: 53 other events
Deaths: 0 deaths
Arm V (8-21 Years of Age, SDCSI, IFRT)
Serious events: 16 serious events
Other events: 123 other events
Deaths: 0 deaths
Arm VI (8-21 Years of Age, SDCSI, PFRT)
Serious events: 18 serious events
Other events: 135 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I (3-7 Years of Age, LDCSI, IFRT)
n=63 participants at risk
See Detailed Description (Arm I)
Cisplatin: Given IV
Craniospinal Irradiation: Undergo craniospinal Irradiation
Cyclophosphamide: Given IV
Involved-Field Radiation Therapy: Undergo smaller volume boost (involved-field radiation therapy)
Laboratory Biomarker Analysis: Correlative studies
Lomustine: Given orally
Quality-of-Life Assessment: Ancillary studies
Vincristine Sulfate: Given IV
|
Arm II (3-7 Years of Age, LDCSI, PFRT)
n=64 participants at risk
See Detailed Description (Arm II)
Cisplatin: Given IV
Craniospinal Irradiation: Undergo craniospinal Irradiation
Cyclophosphamide: Given IV
Laboratory Biomarker Analysis: Correlative studies
Lomustine: Given orally
Quality-of-Life Assessment: Ancillary studies
Radiation Therapy: Undergo standard volume boost (whole posterior fossa radiation therapy)
Vincristine Sulfate: Given IV
|
Arm III (3-7 Years of Age, SDCSI, IFRT)
n=60 participants at risk
See Detailed Description (Arm III)
Cisplatin: Given IV
Craniospinal Irradiation: Undergo craniospinal Irradiation
Cyclophosphamide: Given IV
Involved-Field Radiation Therapy: Undergo smaller volume boost (involved-field radiation therapy)
Laboratory Biomarker Analysis: Correlative studies
Lomustine: Given orally
Quality-of-Life Assessment: Ancillary studies
Vincristine Sulfate: Given IV
|
Arm IV (3-7 Years of Age, SDCSI, PFRT)
n=58 participants at risk
See Detailed Description (Arm IV)
Craniospinal Irradiation: Undergo craniospinal Irradiation
Cyclophosphamide: Given IV
Laboratory Biomarker Analysis: Correlative studies
Lomustine: Given orally
Quality-of-Life Assessment: Ancillary studies
Radiation Therapy: Undergo standard volume boost (whole posterior fossa radiation therapy)
Vincristine Sulfate: Given IV
|
Arm V (8-21 Years of Age, SDCSI, IFRT)
n=130 participants at risk
See Detailed Description (Arm V)
Cisplatin: Given IV
Craniospinal Irradiation: Undergo craniospinal Irradiation
Cyclophosphamide: Given IV
Involved-Field Radiation Therapy: Undergo smaller volume boost (involved-field radiation therapy)
Laboratory Biomarker Analysis: Correlative studies
Lomustine: Given orally
Quality-of-Life Assessment: Ancillary studies
Vincristine Sulfate: Given IV
|
Arm VI (8-21 Years of Age, SDCSI, PFRT)
n=138 participants at risk
See Detailed Description (Arm VI)
Cisplatin: Given IV
Craniospinal Irradiation: Undergo craniospinal Irradiation
Cyclophosphamide: Given IV
Laboratory Biomarker Analysis: Correlative studies
Lomustine: Given orally
Quality-of-Life Assessment: Ancillary studies
Radiation Therapy: Undergo standard volume boost (whole posterior fossa radiation therapy)
Vincristine Sulfate: Given IV
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
1.6%
1/63 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.77%
1/130 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.77%
1/130 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
3.1%
2/64 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.77%
1/130 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Infections and infestations
Encephalomyelitis infection
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/60 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Infections and infestations
Sepsis
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.6%
1/64 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.6%
1/64 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.77%
1/130 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
2.2%
3/138 • Number of events 3
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Investigations
Aspartate aminotransferase increased
|
3.2%
2/63 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/58 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.4%
2/138 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Investigations
Blood bilirubin increased
|
1.6%
1/63 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.6%
1/64 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
6.2%
4/64 • Number of events 6
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/60 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
3.1%
4/130 • Number of events 5
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
2.2%
3/138 • Number of events 3
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Investigations
Platelet count decreased
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
3.1%
2/64 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.5%
2/130 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.4%
2/138 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Investigations
Weight loss
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Investigations
White blood cell decreased
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/60 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.77%
1/130 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.77%
1/130 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
1.6%
1/63 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/60 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
1.6%
1/63 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/60 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/58 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
2.3%
3/130 • Number of events 3
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
2.9%
4/138 • Number of events 4
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/58 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Nervous system disorders
Central nervous system necrosis
|
1.6%
1/63 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/58 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Nervous system disorders
Cognitive disturbance
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/58 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Nervous system disorders
Depressed level of consciousness
|
1.6%
1/63 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/58 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Nervous system disorders
Myelitis
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/58 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.77%
1/130 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
3.2%
2/63 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/60 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/58 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.77%
1/130 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.4%
2/138 • Number of events 4
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.5%
2/130 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
2.2%
3/138 • Number of events 3
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Nervous system disorders
Seizure
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.6%
1/64 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.77%
1/130 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.6%
1/64 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.6%
1/63 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
Other adverse events
| Measure |
Arm I (3-7 Years of Age, LDCSI, IFRT)
n=63 participants at risk
See Detailed Description (Arm I)
Cisplatin: Given IV
Craniospinal Irradiation: Undergo craniospinal Irradiation
Cyclophosphamide: Given IV
Involved-Field Radiation Therapy: Undergo smaller volume boost (involved-field radiation therapy)
Laboratory Biomarker Analysis: Correlative studies
Lomustine: Given orally
Quality-of-Life Assessment: Ancillary studies
Vincristine Sulfate: Given IV
|
Arm II (3-7 Years of Age, LDCSI, PFRT)
n=64 participants at risk
See Detailed Description (Arm II)
Cisplatin: Given IV
Craniospinal Irradiation: Undergo craniospinal Irradiation
Cyclophosphamide: Given IV
Laboratory Biomarker Analysis: Correlative studies
Lomustine: Given orally
Quality-of-Life Assessment: Ancillary studies
Radiation Therapy: Undergo standard volume boost (whole posterior fossa radiation therapy)
Vincristine Sulfate: Given IV
|
Arm III (3-7 Years of Age, SDCSI, IFRT)
n=60 participants at risk
See Detailed Description (Arm III)
Cisplatin: Given IV
Craniospinal Irradiation: Undergo craniospinal Irradiation
Cyclophosphamide: Given IV
Involved-Field Radiation Therapy: Undergo smaller volume boost (involved-field radiation therapy)
Laboratory Biomarker Analysis: Correlative studies
Lomustine: Given orally
Quality-of-Life Assessment: Ancillary studies
Vincristine Sulfate: Given IV
|
Arm IV (3-7 Years of Age, SDCSI, PFRT)
n=58 participants at risk
See Detailed Description (Arm IV)
Craniospinal Irradiation: Undergo craniospinal Irradiation
Cyclophosphamide: Given IV
Laboratory Biomarker Analysis: Correlative studies
Lomustine: Given orally
Quality-of-Life Assessment: Ancillary studies
Radiation Therapy: Undergo standard volume boost (whole posterior fossa radiation therapy)
Vincristine Sulfate: Given IV
|
Arm V (8-21 Years of Age, SDCSI, IFRT)
n=130 participants at risk
See Detailed Description (Arm V)
Cisplatin: Given IV
Craniospinal Irradiation: Undergo craniospinal Irradiation
Cyclophosphamide: Given IV
Involved-Field Radiation Therapy: Undergo smaller volume boost (involved-field radiation therapy)
Laboratory Biomarker Analysis: Correlative studies
Lomustine: Given orally
Quality-of-Life Assessment: Ancillary studies
Vincristine Sulfate: Given IV
|
Arm VI (8-21 Years of Age, SDCSI, PFRT)
n=138 participants at risk
See Detailed Description (Arm VI)
Cisplatin: Given IV
Craniospinal Irradiation: Undergo craniospinal Irradiation
Cyclophosphamide: Given IV
Laboratory Biomarker Analysis: Correlative studies
Lomustine: Given orally
Quality-of-Life Assessment: Ancillary studies
Radiation Therapy: Undergo standard volume boost (whole posterior fossa radiation therapy)
Vincristine Sulfate: Given IV
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
47.6%
30/63 • Number of events 109
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
46.9%
30/64 • Number of events 117
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
40.0%
24/60 • Number of events 125
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
46.6%
27/58 • Number of events 104
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
47.7%
62/130 • Number of events 278
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
39.9%
55/138 • Number of events 203
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.6%
1/64 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.6%
1/64 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
39.7%
25/63 • Number of events 40
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
28.1%
18/64 • Number of events 32
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
36.7%
22/60 • Number of events 40
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
43.1%
25/58 • Number of events 48
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
32.3%
42/130 • Number of events 69
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
34.8%
48/138 • Number of events 68
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.6%
1/64 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/58 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/58 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/58 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.77%
1/130 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/60 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify
|
3.2%
2/63 • Number of events 4
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/60 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/58 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.77%
1/130 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.4%
2/138 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.5%
2/130 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Ear and labyrinth disorders
External ear inflammation
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.6%
1/64 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Ear and labyrinth disorders
External ear pain
|
1.6%
1/63 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Ear and labyrinth disorders
Hearing impaired
|
12.7%
8/63 • Number of events 20
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
25.0%
16/64 • Number of events 27
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
20.0%
12/60 • Number of events 18
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
10.3%
6/58 • Number of events 11
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
12.3%
16/130 • Number of events 27
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
8.0%
11/138 • Number of events 23
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Ear and labyrinth disorders
Middle ear inflammation
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.6%
1/64 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
3.3%
2/60 • Number of events 3
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/58 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
2.3%
3/130 • Number of events 3
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.77%
1/130 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Endocrine disorders
Endocrine disorders - Other, specify
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.6%
1/64 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.77%
1/130 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Eye disorders
Blurred vision
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.4%
2/138 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Eye disorders
Cataract
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/60 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Eye disorders
Extraocular muscle paresis
|
1.6%
1/63 • Number of events 7
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
3.1%
2/64 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.5%
2/130 • Number of events 3
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 10
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Eye disorders
Eye disorders - Other, specify
|
1.6%
1/63 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.77%
1/130 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 3
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Eye disorders
Eyelid function disorder
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/58 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Eye disorders
Optic nerve disorder
|
1.6%
1/63 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/60 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.77%
1/130 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Eye disorders
Photophobia
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Eye disorders
Watering eyes
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.6%
1/64 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.5%
2/130 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.3%
4/63 • Number of events 8
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
3.1%
2/64 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/60 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/58 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
9.2%
12/130 • Number of events 22
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
9.4%
13/138 • Number of events 19
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Gastrointestinal disorders
Anal pain
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/60 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.77%
1/130 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.5%
2/130 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Gastrointestinal disorders
Constipation
|
1.6%
1/63 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
6.2%
4/64 • Number of events 5
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
11.7%
7/60 • Number of events 15
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
6.9%
4/58 • Number of events 4
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
10.8%
14/130 • Number of events 19
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
15.2%
21/138 • Number of events 23
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.77%
1/130 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Gastrointestinal disorders
Diarrhea
|
4.8%
3/63 • Number of events 3
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.6%
1/64 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
10.0%
6/60 • Number of events 7
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
6.2%
8/130 • Number of events 9
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
5.8%
8/138 • Number of events 9
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/60 • Number of events 4
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Gastrointestinal disorders
Dysphagia
|
1.6%
1/63 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
3.4%
2/58 • Number of events 11
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.5%
2/130 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.4%
2/138 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Gastrointestinal disorders
Esophageal pain
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.77%
1/130 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Gastrointestinal disorders
Esophageal perforation
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Gastrointestinal disorders
Esophagitis
|
1.6%
1/63 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.6%
1/64 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.77%
1/130 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
2.2%
3/138 • Number of events 3
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Gastrointestinal disorders
Fecal incontinence
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/60 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.77%
1/130 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.4%
2/138 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/58 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
2.2%
3/138 • Number of events 3
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Gastrointestinal disorders
Gastroparesis
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.77%
1/130 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.77%
1/130 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Gastrointestinal disorders
Ileus
|
6.3%
4/63 • Number of events 8
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
7.8%
5/64 • Number of events 7
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
10.0%
6/60 • Number of events 9
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
6.9%
4/58 • Number of events 15
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
14.6%
19/130 • Number of events 34
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
10.1%
14/138 • Number of events 22
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
4.7%
3/64 • Number of events 3
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
3.3%
2/60 • Number of events 3
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
3.4%
2/58 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
3.8%
5/130 • Number of events 5
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
2.9%
4/138 • Number of events 4
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Gastrointestinal disorders
Nausea
|
7.9%
5/63 • Number of events 8
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
4.7%
3/64 • Number of events 5
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
5.0%
3/60 • Number of events 4
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
3.4%
2/58 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
22.3%
29/130 • Number of events 56
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
15.9%
22/138 • Number of events 42
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Gastrointestinal disorders
Oral pain
|
1.6%
1/63 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/58 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
2.2%
3/138 • Number of events 4
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Gastrointestinal disorders
Rectal pain
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Gastrointestinal disorders
Stomach pain
|
1.6%
1/63 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.6%
1/64 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.77%
1/130 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.77%
1/130 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Gastrointestinal disorders
Typhlitis
|
3.2%
2/63 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.6%
1/64 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/60 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.4%
2/138 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.5%
2/130 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Gastrointestinal disorders
Vomiting
|
9.5%
6/63 • Number of events 8
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
6.2%
4/64 • Number of events 7
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
8.3%
5/60 • Number of events 8
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
15.5%
9/58 • Number of events 15
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
23.1%
30/130 • Number of events 49
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
22.5%
31/138 • Number of events 49
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
General disorders
Chills
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/60 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.77%
1/130 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
General disorders
Facial pain
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
General disorders
Fatigue
|
3.2%
2/63 • Number of events 3
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
3.1%
2/64 • Number of events 4
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
3.3%
2/60 • Number of events 4
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
5.2%
3/58 • Number of events 4
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
9.2%
12/130 • Number of events 17
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
6.5%
9/138 • Number of events 21
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
General disorders
Fever
|
6.3%
4/63 • Number of events 4
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
6.2%
4/64 • Number of events 5
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
10.0%
6/60 • Number of events 7
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
6.9%
4/58 • Number of events 5
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
6.9%
9/130 • Number of events 11
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
3.6%
5/138 • Number of events 6
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
General disorders
Gait disturbance
|
1.6%
1/63 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.6%
1/64 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/58 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.5%
2/130 • Number of events 6
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
General disorders
Localized edema
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.6%
1/64 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
General disorders
Multi-organ failure
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.6%
1/64 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.77%
1/130 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
General disorders
Pain
|
3.2%
2/63 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.6%
1/64 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
5.4%
7/130 • Number of events 8
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
2.9%
4/138 • Number of events 5
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.77%
1/130 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Immune system disorders
Allergic reaction
|
1.6%
1/63 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.6%
1/64 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/60 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.77%
1/130 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Immune system disorders
Anaphylaxis
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/60 • Number of events 3
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/58 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.77%
1/130 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.4%
2/138 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Immune system disorders
Autoimmune disorder
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.6%
1/64 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.5%
2/130 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Infections and infestations
Appendicitis perforated
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.6%
1/64 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Infections and infestations
Bladder infection
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.6%
1/64 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Infections and infestations
Bronchial infection
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.77%
1/130 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
10.9%
7/64 • Number of events 9
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
6.7%
4/60 • Number of events 6
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
5.2%
3/58 • Number of events 3
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
4.6%
6/130 • Number of events 9
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
6.5%
9/138 • Number of events 9
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Infections and infestations
Conjunctivitis infective
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Infections and infestations
Device related infection
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.77%
1/130 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Infections and infestations
Encephalomyelitis infection
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/60 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Infections and infestations
Enterocolitis infectious
|
1.6%
1/63 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/60 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/58 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
2.3%
3/130 • Number of events 4
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.4%
2/138 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Infections and infestations
Esophageal infection
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Infections and infestations
Eye infection
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Infections and infestations
Gallbladder infection
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Infections and infestations
Gum infection
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
19.0%
12/63 • Number of events 12
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
15.6%
10/64 • Number of events 16
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
25.0%
15/60 • Number of events 24
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
27.6%
16/58 • Number of events 35
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
21.5%
28/130 • Number of events 50
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
21.7%
30/138 • Number of events 48
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.77%
1/130 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Infections and infestations
Lip infection
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.5%
2/130 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Infections and infestations
Lung infection
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
3.1%
2/64 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/60 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/58 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.5%
2/130 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Infections and infestations
Meningitis
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.6%
1/64 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/60 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.6%
1/64 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.5%
2/130 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.77%
1/130 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Infections and infestations
Otitis media
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.6%
1/64 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
3.4%
2/58 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.4%
2/138 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Infections and infestations
Peripheral nerve infection
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Infections and infestations
Phlebitis infective
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Infections and infestations
Rash pustular
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Infections and infestations
Sepsis
|
6.3%
4/63 • Number of events 8
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/60 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
4.7%
3/64 • Number of events 3
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.5%
2/130 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Infections and infestations
Skin infection
|
1.6%
1/63 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
3.3%
2/60 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
3.4%
2/58 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.5%
2/130 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
3.6%
5/138 • Number of events 5
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Infections and infestations
Small intestine infection
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/60 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Infections and infestations
Stoma site infection
|
1.6%
1/63 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.6%
1/64 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.77%
1/130 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.77%
1/130 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Infections and infestations
Tracheitis
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/60 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Infections and infestations
Upper respiratory infection
|
4.8%
3/63 • Number of events 3
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
3.1%
2/64 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
3.4%
2/58 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
3.1%
4/130 • Number of events 4
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/60 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/58 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.5%
2/130 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Infections and infestations
Wound infection
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.77%
1/130 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Injury, poisoning and procedural complications
Aortic injury
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/58 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Injury, poisoning and procedural complications
Burn
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
3.1%
2/64 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.77%
1/130 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.5%
2/130 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Injury, poisoning and procedural complications
Radiation recall reaction (dermatologic)
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/58 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.77%
1/130 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.4%
2/138 • Number of events 3
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
1.6%
1/63 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.5%
2/130 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Investigations
Alanine aminotransferase increased
|
65.1%
41/63 • Number of events 148
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
56.2%
36/64 • Number of events 112
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
60.0%
36/60 • Number of events 145
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
63.8%
37/58 • Number of events 123
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
73.1%
95/130 • Number of events 415
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
68.8%
95/138 • Number of events 426
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Investigations
Alkaline phosphatase increased
|
1.6%
1/63 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/58 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Investigations
Aspartate aminotransferase increased
|
57.1%
36/63 • Number of events 113
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
54.7%
35/64 • Number of events 122
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
55.0%
33/60 • Number of events 96
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
55.2%
32/58 • Number of events 91
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
63.8%
83/130 • Number of events 302
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
63.0%
87/138 • Number of events 322
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Investigations
Blood antidiuretic hormone abnormal
|
1.6%
1/63 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.77%
1/130 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Investigations
Blood bilirubin increased
|
17.5%
11/63 • Number of events 18
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
10.9%
7/64 • Number of events 14
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
15.0%
9/60 • Number of events 19
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
10.3%
6/58 • Number of events 8
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
22.3%
29/130 • Number of events 65
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
15.2%
21/138 • Number of events 43
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Investigations
Blood corticotrophin decreased
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Investigations
Cholesterol high
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/60 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Investigations
Creatinine increased
|
7.9%
5/63 • Number of events 8
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
15.6%
10/64 • Number of events 20
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
25.0%
15/60 • Number of events 30
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
10.3%
6/58 • Number of events 15
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
23.1%
30/130 • Number of events 76
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
21.7%
30/138 • Number of events 59
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Investigations
Fibrinogen decreased
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.77%
1/130 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Investigations
GGT increased
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
2.3%
3/130 • Number of events 3
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
2.2%
3/138 • Number of events 4
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Investigations
Growth hormone abnormal
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.6%
1/64 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Investigations
Haptoglobin decreased
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Investigations
Investigations - Other, specify
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/60 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Investigations
Lipase increased
|
1.6%
1/63 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.77%
1/130 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.4%
2/138 • Number of events 3
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Investigations
Lymphocyte count decreased
|
17.5%
11/63 • Number of events 60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
21.9%
14/64 • Number of events 69
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
26.7%
16/60 • Number of events 97
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
15.5%
9/58 • Number of events 48
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
24.6%
32/130 • Number of events 220
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
27.5%
38/138 • Number of events 226
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Investigations
Neutrophil count decreased
|
92.1%
58/63 • Number of events 450
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
90.6%
58/64 • Number of events 421
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
85.0%
51/60 • Number of events 404
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
89.7%
52/58 • Number of events 362
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
90.8%
118/130 • Number of events 923
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
93.5%
129/138 • Number of events 932
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Investigations
Platelet count decreased
|
73.0%
46/63 • Number of events 253
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
67.2%
43/64 • Number of events 217
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
71.7%
43/60 • Number of events 269
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
70.7%
41/58 • Number of events 234
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
83.1%
108/130 • Number of events 687
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
85.5%
118/138 • Number of events 705
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Investigations
Serum amylase increased
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/60 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.5%
2/130 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Investigations
Weight gain
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/58 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.77%
1/130 • Number of events 5
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Investigations
Weight loss
|
12.7%
8/63 • Number of events 15
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
10.9%
7/64 • Number of events 20
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
13.3%
8/60 • Number of events 10
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
8.6%
5/58 • Number of events 6
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
18.5%
24/130 • Number of events 39
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
22.5%
31/138 • Number of events 43
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Investigations
White blood cell decreased
|
47.6%
30/63 • Number of events 147
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
34.4%
22/64 • Number of events 117
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
43.3%
26/60 • Number of events 136
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
43.1%
25/58 • Number of events 108
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
46.2%
60/130 • Number of events 322
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
45.7%
63/138 • Number of events 341
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Metabolism and nutrition disorders
Acidosis
|
1.6%
1/63 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
3.3%
2/60 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
5.2%
3/58 • Number of events 5
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
3.1%
4/130 • Number of events 10
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Metabolism and nutrition disorders
Anorexia
|
23.8%
15/63 • Number of events 34
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
6.2%
4/64 • Number of events 13
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
15.0%
9/60 • Number of events 20
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
12.1%
7/58 • Number of events 16
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
25.4%
33/130 • Number of events 96
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
26.8%
37/138 • Number of events 109
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.2%
2/63 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
6.2%
4/64 • Number of events 4
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
8.3%
5/60 • Number of events 5
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/58 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
8.5%
11/130 • Number of events 12
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
6.5%
9/138 • Number of events 12
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
15.9%
10/63 • Number of events 15
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
10.9%
7/64 • Number of events 9
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
21.7%
13/60 • Number of events 21
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
8.6%
5/58 • Number of events 6
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
13.8%
18/130 • Number of events 27
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
16.7%
23/138 • Number of events 44
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
9.5%
6/63 • Number of events 14
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
4.7%
3/64 • Number of events 3
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/60 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
3.4%
2/58 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
10.0%
13/130 • Number of events 24
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
5.8%
8/138 • Number of events 14
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.6%
1/64 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/60 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
2.3%
3/130 • Number of events 4
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
3.2%
2/63 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
4.7%
3/64 • Number of events 3
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
5.0%
3/60 • Number of events 6
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
6.9%
4/58 • Number of events 7
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
6.9%
9/130 • Number of events 11
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
3.6%
5/138 • Number of events 8
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/60 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.77%
1/130 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/60 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.77%
1/130 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
1.6%
1/63 • Number of events 4
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
3.1%
2/64 • Number of events 5
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
3.3%
2/60 • Number of events 3
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
2.3%
3/130 • Number of events 7
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
2.9%
4/138 • Number of events 9
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
6.3%
4/63 • Number of events 9
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.6%
1/64 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
6.7%
4/60 • Number of events 10
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
3.4%
2/58 • Number of events 4
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
7.7%
10/130 • Number of events 11
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
3.6%
5/138 • Number of events 9
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
1.6%
1/63 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
3.3%
2/60 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.5%
2/130 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.4%
2/138 • Number of events 4
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
15.9%
10/63 • Number of events 21
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
17.2%
11/64 • Number of events 19
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
15.0%
9/60 • Number of events 14
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
15.5%
9/58 • Number of events 16
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
20.0%
26/130 • Number of events 49
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
14.5%
20/138 • Number of events 32
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
31.7%
20/63 • Number of events 44
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
31.2%
20/64 • Number of events 51
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
48.3%
29/60 • Number of events 91
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
36.2%
21/58 • Number of events 41
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
41.5%
54/130 • Number of events 185
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
37.7%
52/138 • Number of events 157
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
4.8%
3/63 • Number of events 8
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
5.0%
3/60 • Number of events 5
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
5.2%
3/58 • Number of events 5
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
5.4%
7/130 • Number of events 11
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
3.6%
5/138 • Number of events 11
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
3.2%
2/63 • Number of events 8
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.6%
1/64 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
6.7%
4/60 • Number of events 10
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/58 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
9.2%
12/130 • Number of events 19
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
7.2%
10/138 • Number of events 14
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Metabolism and nutrition disorders
Iron overload
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.77%
1/130 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
2.2%
3/138 • Number of events 3
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.6%
1/63 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/60 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
3.1%
4/130 • Number of events 6
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
4.3%
6/138 • Number of events 9
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/60 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.4%
2/138 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.77%
1/130 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
1.6%
1/63 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/58 • Number of events 5
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.77%
1/130 • Number of events 5
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.4%
2/138 • Number of events 9
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Musculoskeletal and connective tissue disorders
Growth suppression
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left-sided
|
1.6%
1/63 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.4%
2/138 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.6%
1/64 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.5%
2/130 • Number of events 4
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.4%
2/138 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness right-sided
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.5%
2/130 • Number of events 4
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.5%
2/130 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.6%
1/64 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.77%
1/130 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.6%
1/63 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
5.0%
3/60 • Number of events 3
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.77%
1/130 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Nervous system disorders
Abducens nerve disorder
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
5.0%
3/60 • Number of events 5
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.77%
1/130 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 3
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Nervous system disorders
Acoustic nerve disorder NOS
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.6%
1/64 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Nervous system disorders
Ataxia
|
7.9%
5/63 • Number of events 7
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.6%
1/64 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/60 • Number of events 9
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
3.4%
2/58 • Number of events 7
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.5%
2/130 • Number of events 4
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
4.3%
6/138 • Number of events 20
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Nervous system disorders
Brachial plexopathy
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Nervous system disorders
Central nervous system necrosis
|
1.6%
1/63 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Nervous system disorders
Cerebrospinal fluid leakage
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/58 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Nervous system disorders
Cognitive disturbance
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.77%
1/130 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/60 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.4%
2/138 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.77%
1/130 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
2.2%
3/138 • Number of events 5
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/58 • Number of events 4
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Nervous system disorders
Dysphasia
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.6%
1/64 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.77%
1/130 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
2.2%
3/138 • Number of events 5
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.77%
1/130 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Nervous system disorders
Glossopharyngeal nerve disorder
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Nervous system disorders
Headache
|
1.6%
1/63 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
4.7%
3/64 • Number of events 4
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
6.7%
4/60 • Number of events 4
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/58 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
6.2%
8/130 • Number of events 13
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
10.1%
14/138 • Number of events 23
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Nervous system disorders
Hydrocephalus
|
3.2%
2/63 • Number of events 3
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/60 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
3.4%
2/58 • Number of events 5
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.4%
2/138 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Nervous system disorders
Hypoglossal nerve disorder
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.5%
2/130 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
4.8%
3/63 • Number of events 7
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/60 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.4%
2/138 • Number of events 4
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Nervous system disorders
Neuralgia
|
11.1%
7/63 • Number of events 10
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
7.8%
5/64 • Number of events 16
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
26.7%
16/60 • Number of events 32
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
24.1%
14/58 • Number of events 20
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
26.9%
35/130 • Number of events 109
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
29.7%
41/138 • Number of events 95
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Nervous system disorders
Nystagmus
|
1.6%
1/63 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.4%
2/138 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Nervous system disorders
Oculomotor nerve disorder
|
1.6%
1/63 • Number of events 7
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.6%
1/64 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/58 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.77%
1/130 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
55.6%
35/63 • Number of events 151
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
32.8%
21/64 • Number of events 84
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
56.7%
34/60 • Number of events 135
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
51.7%
30/58 • Number of events 124
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
70.8%
92/130 • Number of events 456
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
66.7%
92/138 • Number of events 431
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
33.3%
21/63 • Number of events 90
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
26.6%
17/64 • Number of events 38
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
30.0%
18/60 • Number of events 70
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
24.1%
14/58 • Number of events 27
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
46.2%
60/130 • Number of events 221
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
47.1%
65/138 • Number of events 228
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Nervous system disorders
Pyramidal tract syndrome
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/60 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Nervous system disorders
Reversible posterior leukoencephalopathy syndrome
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.77%
1/130 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Nervous system disorders
Seizure
|
3.2%
2/63 • Number of events 3
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.6%
1/64 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
3.3%
2/60 • Number of events 3
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/58 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.77%
1/130 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Nervous system disorders
Syncope
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Nervous system disorders
Tremor
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.6%
1/64 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Nervous system disorders
Trigeminal nerve disorder
|
1.6%
1/63 • Number of events 6
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Nervous system disorders
Vagus nerve disorder
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.77%
1/130 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.6%
1/64 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
3.3%
2/60 • Number of events 6
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.77%
1/130 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Psychiatric disorders
Anxiety
|
1.6%
1/63 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/60 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
2.3%
3/130 • Number of events 3
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
2.9%
4/138 • Number of events 6
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Psychiatric disorders
Depression
|
1.6%
1/63 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/60 • Number of events 5
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
6.2%
8/130 • Number of events 10
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
6.5%
9/138 • Number of events 16
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Psychiatric disorders
Hallucinations
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.5%
2/130 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Psychiatric disorders
Personality change
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/60 • Number of events 4
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
2.2%
3/138 • Number of events 3
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.6%
1/64 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Renal and urinary disorders
Bladder spasm
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.77%
1/130 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
3.4%
2/58 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.4%
2/138 • Number of events 5
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Renal and urinary disorders
Proteinuria
|
1.6%
1/63 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.77%
1/130 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
3.2%
2/63 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/58 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.4%
2/138 • Number of events 4
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Reproductive system and breast disorders
Irregular menstruation
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 4
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
1.6%
1/63 • Number of events 4
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/58 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.77%
1/130 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.6%
1/64 • Number of events 3
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.6%
1/63 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
3.3%
2/60 • Number of events 3
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
5.2%
3/58 • Number of events 3
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.77%
1/130 • Number of events 3
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.2%
2/63 • Number of events 4
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
3.4%
2/58 • Number of events 3
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
3.8%
5/130 • Number of events 6
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
5.1%
7/138 • Number of events 7
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.6%
1/63 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.6%
1/64 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.5%
2/130 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
2.2%
3/138 • Number of events 3
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal mucositis
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.77%
1/130 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/60 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.77%
1/130 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
2.2%
3/138 • Number of events 3
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.77%
1/130 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/60 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
6.9%
4/58 • Number of events 4
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.4%
2/138 • Number of events 3
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.6%
1/63 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.77%
1/130 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.6%
1/64 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.77%
1/130 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
4.8%
3/63 • Number of events 5
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.6%
1/64 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
3.3%
2/60 • Number of events 3
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/58 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
3.1%
4/130 • Number of events 12
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
2.2%
3/138 • Number of events 9
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/60 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/58 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.5%
2/130 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
2.9%
4/138 • Number of events 6
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/60 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.5%
2/130 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
1.6%
1/63 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/60 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/60 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/58 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.77%
1/130 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.77%
1/130 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/60 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify
|
1.6%
1/63 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Vascular disorders
Hematoma
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.6%
1/64 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/130
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Vascular disorders
Hypertension
|
3.2%
2/63 • Number of events 4
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
3.1%
2/64 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
1.7%
1/60 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
3.1%
4/130 • Number of events 5
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
2.9%
4/138 • Number of events 7
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Vascular disorders
Hypotension
|
1.6%
1/63 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
3.3%
2/60 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
3.4%
2/58 • Number of events 2
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
3.1%
4/130 • Number of events 4
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.72%
1/138 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
|
Vascular disorders
Vascular disorders - Other, specify
|
0.00%
0/63
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/64
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/60
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/58
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.77%
1/130 • Number of events 1
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
0.00%
0/138
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
|
Additional Information
Results Reporting Coordinator
Childrens's Oncology Group
Phone: 626-447-0064
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place