Trial Outcomes & Findings for Temozolomide With or Without Veliparib in Treating Patients With Newly Diagnosed Glioblastoma Multiforme (NCT NCT02152982)
NCT ID: NCT02152982
Last Updated: 2025-11-28
Results Overview
The distribution of OS for each arm will be estimated using the Kaplan-Meier method and compared with a stratified logrank test.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2/PHASE3
Target enrollment
447 participants
Primary outcome timeframe
83 months
Results posted on
2025-11-28
Participant Flow
Participant milestones
| Measure |
Arm II (Temozolomide, Veliparib)
Patients receive temozolomide PO QD on days 1-5 and veliparib PO BID on days 1-7. Treatment repeats every 28 days for 6 cycles in the absence of disease progression (confirmed progression) or unacceptable toxicity. \> \> Laboratory Biomarker Analysis: Correlative studies \>
* Quality-of-Life Assessment: Ancillary studies \>
* Temozolomide: Given PO \>
* Veliparib: Given PO
|
Arm I (Temozolomide, Placebo)
Patients receive temozolomide as in Arm II and placebo PO BID on days 1-7. Treatment repeats every 28 days for 6 cycles in the absence of disease progression (confirmed progression) or unacceptable toxicity. \> \> Laboratory Biomarker Analysis: Correlative studies \>
* Placebo Administration: Given PO \>
* Quality-of-Life Assessment: Ancillary studies \>
* Temozolomide: Given PO
|
|---|---|---|
|
Overall Study
STARTED
|
223
|
224
|
|
Overall Study
Started Treatment
|
218
|
213
|
|
Overall Study
COMPLETED
|
134
|
144
|
|
Overall Study
NOT COMPLETED
|
89
|
80
|
Reasons for withdrawal
| Measure |
Arm II (Temozolomide, Veliparib)
Patients receive temozolomide PO QD on days 1-5 and veliparib PO BID on days 1-7. Treatment repeats every 28 days for 6 cycles in the absence of disease progression (confirmed progression) or unacceptable toxicity. \> \> Laboratory Biomarker Analysis: Correlative studies \>
* Quality-of-Life Assessment: Ancillary studies \>
* Temozolomide: Given PO \>
* Veliparib: Given PO
|
Arm I (Temozolomide, Placebo)
Patients receive temozolomide as in Arm II and placebo PO BID on days 1-7. Treatment repeats every 28 days for 6 cycles in the absence of disease progression (confirmed progression) or unacceptable toxicity. \> \> Laboratory Biomarker Analysis: Correlative studies \>
* Placebo Administration: Given PO \>
* Quality-of-Life Assessment: Ancillary studies \>
* Temozolomide: Given PO
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
16
|
17
|
|
Overall Study
Did not start treatment
|
5
|
11
|
|
Overall Study
Disease progression
|
52
|
41
|
|
Overall Study
Adverse Event
|
12
|
7
|
|
Overall Study
Complicating disease
|
1
|
1
|
|
Overall Study
Death
|
3
|
0
|
|
Overall Study
Physician Decision
|
0
|
3
|
Baseline Characteristics
Temozolomide With or Without Veliparib in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
Baseline characteristics by cohort
| Measure |
Arm I (Temozolomide, Placebo)
n=224 Participants
Patients receive temozolomide as in Arm II and placebo PO BID on days 1-7. Treatment repeats every 28 days for 6 cycles in the absence of disease progression (confirmed progression) or unacceptable toxicity. \> \> Laboratory Biomarker Analysis: Correlative studies \>\> Placebo Administration: Given PO \>\> Quality-of-Life Assessment: Ancillary studies \>\> Temozolomide: Given PO
|
Arm II (Temozolomide, Veliparib)
n=223 Participants
Patients receive temozolomide PO QD on days 1-5 and veliparib PO BID on days 1-7. Treatment repeats every 28 days for 6 cycles in the absence of disease progression (confirmed progression) or unacceptable toxicity. \> \> Laboratory Biomarker Analysis: Correlative studies \>\> Quality-of-Life Assessment: Ancillary studies \>\> Temozolomide: Given PO \>\> Veliparib: Given PO
|
Total
n=447 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.3 years
STANDARD_DEVIATION 12.40 • n=30 Participants
|
58.8 years
STANDARD_DEVIATION 11.55 • n=30 Participants
|
58.5 years
STANDARD_DEVIATION 11.97 • n=60 Participants
|
|
Sex: Female, Male
Female
|
94 Participants
n=30 Participants
|
96 Participants
n=30 Participants
|
190 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
130 Participants
n=30 Participants
|
127 Participants
n=30 Participants
|
257 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=30 Participants
|
7 Participants
n=30 Participants
|
16 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
208 Participants
n=30 Participants
|
212 Participants
n=30 Participants
|
420 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=30 Participants
|
4 Participants
n=30 Participants
|
11 Participants
n=60 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=30 Participants
|
4 Participants
n=30 Participants
|
8 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=30 Participants
|
6 Participants
n=30 Participants
|
17 Participants
n=60 Participants
|
|
Race (NIH/OMB)
White
|
197 Participants
n=30 Participants
|
199 Participants
n=30 Participants
|
396 Participants
n=60 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=30 Participants
|
14 Participants
n=30 Participants
|
25 Participants
n=60 Participants
|
|
Extent of Resection
Gross total resection
|
140 Participants
n=30 Participants
|
140 Participants
n=30 Participants
|
280 Participants
n=60 Participants
|
|
Extent of Resection
Subtotal resection or biopsy
|
84 Participants
n=30 Participants
|
83 Participants
n=30 Participants
|
167 Participants
n=60 Participants
|
|
ECOG Performance Status
0-1
|
205 Participants
n=30 Participants
|
205 Participants
n=30 Participants
|
410 Participants
n=60 Participants
|
|
ECOG Performance Status
2
|
19 Participants
n=30 Participants
|
18 Participants
n=30 Participants
|
37 Participants
n=60 Participants
|
|
Side of Lesion
Bilateral
|
3 Participants
n=30 Participants
|
8 Participants
n=30 Participants
|
11 Participants
n=60 Participants
|
|
Side of Lesion
Left
|
107 Participants
n=30 Participants
|
106 Participants
n=30 Participants
|
213 Participants
n=60 Participants
|
|
Side of Lesion
Midline
|
1 Participants
n=30 Participants
|
2 Participants
n=30 Participants
|
3 Participants
n=60 Participants
|
|
Side of Lesion
Right
|
113 Participants
n=30 Participants
|
107 Participants
n=30 Participants
|
220 Participants
n=60 Participants
|
|
Tumor Location
Multiple locations
|
82 Participants
n=30 Participants
|
74 Participants
n=30 Participants
|
156 Participants
n=60 Participants
|
|
Tumor Location
Frontal
|
67 Participants
n=30 Participants
|
65 Participants
n=30 Participants
|
132 Participants
n=60 Participants
|
|
Tumor Location
Occipital
|
3 Participants
n=30 Participants
|
9 Participants
n=30 Participants
|
12 Participants
n=60 Participants
|
|
Tumor Location
Other
|
1 Participants
n=30 Participants
|
3 Participants
n=30 Participants
|
4 Participants
n=60 Participants
|
|
Tumor Location
Parietal
|
26 Participants
n=30 Participants
|
24 Participants
n=30 Participants
|
50 Participants
n=60 Participants
|
|
Tumor Location
Temporal
|
42 Participants
n=30 Participants
|
45 Participants
n=30 Participants
|
87 Participants
n=60 Participants
|
|
Tumor Location
Thalamus
|
3 Participants
n=30 Participants
|
3 Participants
n=30 Participants
|
6 Participants
n=60 Participants
|
|
Planned concomitant use of Optune device
No
|
191 Participants
n=30 Participants
|
194 Participants
n=30 Participants
|
385 Participants
n=60 Participants
|
|
Planned concomitant use of Optune device
Yes
|
33 Participants
n=30 Participants
|
29 Participants
n=30 Participants
|
62 Participants
n=60 Participants
|
PRIMARY outcome
Timeframe: 83 monthsThe distribution of OS for each arm will be estimated using the Kaplan-Meier method and compared with a stratified logrank test.
Outcome measures
| Measure |
Arm I (Temozolomide, Placebo)
n=224 Participants
Patients receive temozolomide as in Arm II and placebo PO BID on days 1-7. Treatment repeats every 28 days for 6 cycles in the absence of disease progression (confirmed progression) or unacceptable toxicity. \> \> Laboratory Biomarker Analysis: Correlative studies \>
\> Placebo Administration: Given PO \>
\> Quality-of-Life Assessment: Ancillary studies \>
\> Temozolomide: Given PO
|
Arm II (Temozolomide, Veliparib)
n=223 Participants
Patients receive temozolomide PO QD on days 1-5 and veliparib PO BID on days 1-7. Treatment repeats every 28 days for 6 cycles in the absence of disease progression (confirmed progression) or unacceptable toxicity. \> \> Laboratory Biomarker Analysis: Correlative studies \>
\> Quality-of-Life Assessment: Ancillary studies \>
\> Temozolomide: Given PO \>
\> Veliparib: Given PO
|
|---|---|---|
|
Overall Survival (OS)
|
24.8 months
Interval 22.6 to 27.7
|
28.1 months
Interval 24.3 to 33.3
|
SECONDARY outcome
Timeframe: 10 yearsPopulation: Analysis population is patients that reported actual optune use
Cox proportional hazards model will be used to evaluate whether there is a potential interaction between the treatment arm and the Optune device. If an interaction is detected, separate analyses of treatment effect (using Cox models) will be done for patients treated with the Optune device and patients who were not treated with the Optune device.
Outcome measures
| Measure |
Arm I (Temozolomide, Placebo)
n=224 Participants
Patients receive temozolomide as in Arm II and placebo PO BID on days 1-7. Treatment repeats every 28 days for 6 cycles in the absence of disease progression (confirmed progression) or unacceptable toxicity. \> \> Laboratory Biomarker Analysis: Correlative studies \>
\> Placebo Administration: Given PO \>
\> Quality-of-Life Assessment: Ancillary studies \>
\> Temozolomide: Given PO
|
Arm II (Temozolomide, Veliparib)
n=223 Participants
Patients receive temozolomide PO QD on days 1-5 and veliparib PO BID on days 1-7. Treatment repeats every 28 days for 6 cycles in the absence of disease progression (confirmed progression) or unacceptable toxicity. \> \> Laboratory Biomarker Analysis: Correlative studies \>
\> Quality-of-Life Assessment: Ancillary studies \>
\> Temozolomide: Given PO \>
\> Veliparib: Given PO
|
|---|---|---|
|
Interaction With Optune Device
Reporting actual Optune use
|
42 participants
|
42 participants
|
|
Interaction With Optune Device
No actual Optune use
|
182 participants
|
181 participants
|
SECONDARY outcome
Timeframe: 120 monthsThe distribution of PFS for each arm will be estimated using the Kaplan-Meier method, and be compared using Cox proportional hazard models with all stratification factors adjusted. Progression (PD): Defined by any of the following: 1. \> 25% increase in sum of products of perpendicular diameters of enhancing lesions, compared with the smallest tumor measurement obtained either at baseline or best response 2. Significant increase in T2/FLAIR non-enhancing lesion on stable or increasing doses of corticosteroids compared with baseline scan or best response after therapy initiation (stable doses of steroids include patient not on steroids) not caused by comorbid events 3. Any new lesion 4. Clear clinical deterioration not attributable to other causes apart from tumor or change in corticosteroid dose 5. Failure to return for evaluation as a result of death or deteriorating condition 6. Clear progression of non-measurable disease
Outcome measures
| Measure |
Arm I (Temozolomide, Placebo)
n=224 Participants
Patients receive temozolomide as in Arm II and placebo PO BID on days 1-7. Treatment repeats every 28 days for 6 cycles in the absence of disease progression (confirmed progression) or unacceptable toxicity. \> \> Laboratory Biomarker Analysis: Correlative studies \>
\> Placebo Administration: Given PO \>
\> Quality-of-Life Assessment: Ancillary studies \>
\> Temozolomide: Given PO
|
Arm II (Temozolomide, Veliparib)
n=223 Participants
Patients receive temozolomide PO QD on days 1-5 and veliparib PO BID on days 1-7. Treatment repeats every 28 days for 6 cycles in the absence of disease progression (confirmed progression) or unacceptable toxicity. \> \> Laboratory Biomarker Analysis: Correlative studies \>
\> Quality-of-Life Assessment: Ancillary studies \>
\> Temozolomide: Given PO \>
\> Veliparib: Given PO
|
|---|---|---|
|
Progression-free Survival (PFS)
|
12.1 months
Interval 10.6 to 14.9
|
13.2 months
Interval 10.5 to 14.9
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: All patients randomized to the trial with measurable disease per RANO criteria at registration and at one or more assessment(s) post-baseline.
Defined as complete response (CR) or partial response (PR) as specified in the Revised Assessment in Neuro-Oncology (RANO) criteria. An objective tumor response will be evaluated for each patient and the tumor response count will be summarized for each arm and compared using the Chi-square test. For CR, all of the following must be true: disappearance of all enhancing measurable and non-measurable disease; no new enhancing lesions; stable or improved non-enhancing lesions; patients must be off corticosteroids; stable or improved clinically A PR requires all of the following: \> 50% decrease in sum of products of perpendicular diameters of all measurable enhancing lesions compared with baseline; no progression of non-measurable disease; no new lesions; stable or improved non-enhancing lesions on same or lower dose of corticosteroids compared with baseline scan; steroid dose should be same or lower compared with baseline scan; stable or improved clinically
Outcome measures
| Measure |
Arm I (Temozolomide, Placebo)
n=118 Participants
Patients receive temozolomide as in Arm II and placebo PO BID on days 1-7. Treatment repeats every 28 days for 6 cycles in the absence of disease progression (confirmed progression) or unacceptable toxicity. \> \> Laboratory Biomarker Analysis: Correlative studies \>
\> Placebo Administration: Given PO \>
\> Quality-of-Life Assessment: Ancillary studies \>
\> Temozolomide: Given PO
|
Arm II (Temozolomide, Veliparib)
n=119 Participants
Patients receive temozolomide PO QD on days 1-5 and veliparib PO BID on days 1-7. Treatment repeats every 28 days for 6 cycles in the absence of disease progression (confirmed progression) or unacceptable toxicity. \> \> Laboratory Biomarker Analysis: Correlative studies \>
\> Quality-of-Life Assessment: Ancillary studies \>
\> Temozolomide: Given PO \>
\> Veliparib: Given PO
|
|---|---|---|
|
Objective Tumor Response
|
34 Participants
|
37 Participants
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: Only includes patients that began treatment
Assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (version 5 beginning April 1, 2018). The overall adverse event rates for grade 3 or higher adverse events will be summarized and be compared using Chi-Square or Fisher's Exact tests between treatment arms. The maximum grade for each type of treatment-related adverse event will be recorded for each patient, and frequency tables for each arm will be reviewed to determine patterns. Treatment-related adverse events will be tabulated for each arm.
Outcome measures
| Measure |
Arm I (Temozolomide, Placebo)
n=213 Participants
Patients receive temozolomide as in Arm II and placebo PO BID on days 1-7. Treatment repeats every 28 days for 6 cycles in the absence of disease progression (confirmed progression) or unacceptable toxicity. \> \> Laboratory Biomarker Analysis: Correlative studies \>
\> Placebo Administration: Given PO \>
\> Quality-of-Life Assessment: Ancillary studies \>
\> Temozolomide: Given PO
|
Arm II (Temozolomide, Veliparib)
n=218 Participants
Patients receive temozolomide PO QD on days 1-5 and veliparib PO BID on days 1-7. Treatment repeats every 28 days for 6 cycles in the absence of disease progression (confirmed progression) or unacceptable toxicity. \> \> Laboratory Biomarker Analysis: Correlative studies \>
\> Quality-of-Life Assessment: Ancillary studies \>
\> Temozolomide: Given PO \>
\> Veliparib: Given PO
|
|---|---|---|
|
Overall Adverse Event Rates for Grade 3 or Higher Adverse Events
|
93 participants with at least 1 grade 3+ AE
|
133 participants with at least 1 grade 3+ AE
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to up to 5 yearsMeasured by the fatigue/uniscale tool. The fatigue/uniscale tool will be used as a measure of QOL. Potential differences in fatigue levels of patients treated on the two different arms will be evaluated. Changes in this measure will be evaluated over the course of treatment for both arms and will be compared using a two-sample t-test at each timepoint. Will also compute a normalized area under the curve (AUC) for the values of each patient over time and compare the mean AUCs for patients on the two arms.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineThe concordance between site-determined MGMT methylation status and central laboratory determination of MGMT status will be analyzed using the Chi-Square test of proportions and 95% confidence intervals for the proportion of tests in disagreement with the local site.
Outcome measures
Outcome data not reported
Adverse Events
Arm I (Temozolomide, Placebo)
Serious events: 47 serious events
Other events: 207 other events
Deaths: 175 deaths
Arm II (Temozolomide, Veliparib)
Serious events: 43 serious events
Other events: 217 other events
Deaths: 183 deaths
Serious adverse events
| Measure |
Arm I (Temozolomide, Placebo)
n=213 participants at risk
Patients receive temozolomide as in Arm II and placebo PO BID on days 1-7. Treatment repeats every 28 days for 6 cycles in the absence of disease progression (confirmed progression) or unacceptable toxicity. \> \> Laboratory Biomarker Analysis: Correlative studies \> \> Placebo Administration: Given PO \> \> Quality-of-Life Assessment: Ancillary studies \> \> Temozolomide: Given PO
|
Arm II (Temozolomide, Veliparib)
n=218 participants at risk
Patients receive temozolomide PO QD on days 1-5 and veliparib PO BID on days 1-7. Treatment repeats every 28 days for 6 cycles in the absence of disease progression (confirmed progression) or unacceptable toxicity. \> \> Laboratory Biomarker Analysis: Correlative studies \> \> Quality-of-Life Assessment: Ancillary studies \> \> Temozolomide: Given PO \> \> Veliparib: Given PO
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/213 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.46%
1/218 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/213 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.92%
2/218 • Number of events 2 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.47%
1/213 • Number of events 6 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.00%
0/218 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/213 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.46%
1/218 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Gastrointestinal disorders
Colitis
|
0.47%
1/213 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.46%
1/218 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Gastrointestinal disorders
Constipation
|
0.47%
1/213 • Number of events 2 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.92%
2/218 • Number of events 2 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/213 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.46%
1/218 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Gastrointestinal disorders
Diarrhea
|
0.94%
2/213 • Number of events 2 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.46%
1/218 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/213 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.46%
1/218 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Gastrointestinal disorders
Dysphagia
|
0.47%
1/213 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.46%
1/218 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/213 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.46%
1/218 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/213 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.46%
1/218 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/213 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.92%
2/218 • Number of events 3 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Gastrointestinal disorders
Stomach pain
|
0.47%
1/213 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.00%
0/218 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Gastrointestinal disorders
Vomiting
|
0.94%
2/213 • Number of events 2 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.46%
1/218 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
General disorders
Edema limbs
|
0.00%
0/213 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.46%
1/218 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
General disorders
Fatigue
|
3.8%
8/213 • Number of events 11 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
3.2%
7/218 • Number of events 7 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
General disorders
Fever
|
0.00%
0/213 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.46%
1/218 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
General disorders
Flu like symptoms
|
0.47%
1/213 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.00%
0/218 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
General disorders
Gen disord and admin site conds-Oth spec
|
0.47%
1/213 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.00%
0/218 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Infections and infestations
Abdominal infection
|
0.47%
1/213 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.00%
0/218 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Infections and infestations
Bladder infection
|
0.00%
0/213 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.46%
1/218 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Infections and infestations
Bronchial infection
|
0.00%
0/213 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.46%
1/218 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Infections and infestations
Infections and infestations - Oth spec
|
0.00%
0/213 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.46%
1/218 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Infections and infestations
Meningitis
|
0.47%
1/213 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.00%
0/218 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/213 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.46%
1/218 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.47%
1/213 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.00%
0/218 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/213 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.46%
1/218 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Investigations
CD4 lymphocytes decreased
|
0.47%
1/213 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.00%
0/218 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Investigations
Creatinine increased
|
0.47%
1/213 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.00%
0/218 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/213 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.92%
2/218 • Number of events 2 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Investigations
White blood cell decreased
|
0.00%
0/213 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.46%
1/218 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.94%
2/213 • Number of events 2 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.46%
1/218 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.94%
2/213 • Number of events 2 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
2.3%
5/218 • Number of events 6 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.47%
1/213 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.00%
0/218 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.47%
1/213 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.46%
1/218 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/213 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.46%
1/218 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.47%
1/213 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.00%
0/218 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.47%
1/213 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.00%
0/218 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
2.8%
6/213 • Number of events 8 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
1.4%
3/218 • Number of events 4 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/213 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.92%
2/218 • Number of events 4 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
0.47%
1/213 • Number of events 2 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.00%
0/218 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.47%
1/213 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.00%
0/218 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Nervous system disorders
Cognitive disturbance
|
0.94%
2/213 • Number of events 2 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.46%
1/218 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/213 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.46%
1/218 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Nervous system disorders
Dysphasia
|
0.47%
1/213 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.00%
0/218 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Nervous system disorders
Edema cerebral
|
0.47%
1/213 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.00%
0/218 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Nervous system disorders
Encephalopathy
|
0.94%
2/213 • Number of events 2 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.46%
1/218 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Nervous system disorders
Headache
|
0.47%
1/213 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.46%
1/218 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Nervous system disorders
Hydrocephalus
|
0.47%
1/213 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.00%
0/218 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Nervous system disorders
Muscle weakness left-sided
|
0.47%
1/213 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.92%
2/218 • Number of events 2 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Nervous system disorders
Muscle weakness right-sided
|
0.00%
0/213 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.92%
2/218 • Number of events 2 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Nervous system disorders
Nervous system disorders - Oth spec
|
0.47%
1/213 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.46%
1/218 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Nervous system disorders
Seizure
|
2.3%
5/213 • Number of events 5 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
3.2%
7/218 • Number of events 7 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Nervous system disorders
Somnolence
|
0.00%
0/213 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.46%
1/218 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Nervous system disorders
Syncope
|
0.94%
2/213 • Number of events 2 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
1.4%
3/218 • Number of events 3 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Psychiatric disorders
Confusion
|
1.9%
4/213 • Number of events 7 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
1.4%
3/218 • Number of events 4 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Psychiatric disorders
Depression
|
0.47%
1/213 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.00%
0/218 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/213 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.46%
1/218 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Psychiatric disorders
Mania
|
0.00%
0/213 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.46%
1/218 • Number of events 2 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Psychiatric disorders
Psychosis
|
0.00%
0/213 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.46%
1/218 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Renal and urinary disorders
Renal and urinary disorders - Oth spec
|
0.00%
0/213 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.46%
1/218 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Renal and urinary disorders
Renal calculi
|
0.00%
0/213 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.46%
1/218 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.47%
1/213 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.00%
0/218 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.47%
1/213 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.00%
0/218 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.47%
1/213 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.46%
1/218 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.47%
1/213 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.00%
0/218 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.94%
2/213 • Number of events 2 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.92%
2/218 • Number of events 2 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Surgical and medical procedures
Surgical and medical proced - Oth spec
|
0.47%
1/213 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.00%
0/218 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Vascular disorders
Hypertension
|
0.94%
2/213 • Number of events 8 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.46%
1/218 • Number of events 4 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Vascular disorders
Thromboembolic event
|
1.9%
4/213 • Number of events 4 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
2.8%
6/218 • Number of events 6 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
Other adverse events
| Measure |
Arm I (Temozolomide, Placebo)
n=213 participants at risk
Patients receive temozolomide as in Arm II and placebo PO BID on days 1-7. Treatment repeats every 28 days for 6 cycles in the absence of disease progression (confirmed progression) or unacceptable toxicity. \> \> Laboratory Biomarker Analysis: Correlative studies \> \> Placebo Administration: Given PO \> \> Quality-of-Life Assessment: Ancillary studies \> \> Temozolomide: Given PO
|
Arm II (Temozolomide, Veliparib)
n=218 participants at risk
Patients receive temozolomide PO QD on days 1-5 and veliparib PO BID on days 1-7. Treatment repeats every 28 days for 6 cycles in the absence of disease progression (confirmed progression) or unacceptable toxicity. \> \> Laboratory Biomarker Analysis: Correlative studies \> \> Quality-of-Life Assessment: Ancillary studies \> \> Temozolomide: Given PO \> \> Veliparib: Given PO
|
|---|---|---|
|
General disorders
Fever
|
1.9%
4/213 • Number of events 5 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.00%
0/218 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Gastrointestinal disorders
Dyspepsia
|
1.4%
3/213 • Number of events 4 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.92%
2/218 • Number of events 7 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Gastrointestinal disorders
Dysphagia
|
0.94%
2/213 • Number of events 4 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.92%
2/218 • Number of events 2 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.94%
2/213 • Number of events 7 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.46%
1/218 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Oth spec
|
0.00%
0/213 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.92%
2/218 • Number of events 2 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
0.47%
1/213 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.00%
0/218 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/213 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
1.4%
3/218 • Number of events 3 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Gastrointestinal disorders
Nausea
|
60.6%
129/213 • Number of events 367 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
57.8%
126/218 • Number of events 355 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Gastrointestinal disorders
Vomiting
|
7.0%
15/213 • Number of events 18 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
8.7%
19/218 • Number of events 29 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
General disorders
Chills
|
1.9%
4/213 • Number of events 5 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.92%
2/218 • Number of events 3 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
General disorders
Death NOS
|
0.47%
1/213 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.92%
2/218 • Number of events 2 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
General disorders
Edema face
|
0.00%
0/213 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.46%
1/218 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
General disorders
Edema limbs
|
1.4%
3/213 • Number of events 5 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
1.4%
3/218 • Number of events 5 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Gastrointestinal disorders
Abdominal pain
|
0.94%
2/213 • Number of events 2 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.92%
2/218 • Number of events 3 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Gastrointestinal disorders
Constipation
|
46.5%
99/213 • Number of events 294 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
43.1%
94/218 • Number of events 256 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
General disorders
Fatigue
|
85.4%
182/213 • Number of events 744 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
83.0%
181/218 • Number of events 734 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Gastrointestinal disorders
Diarrhea
|
18.8%
40/213 • Number of events 85 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
20.6%
45/218 • Number of events 88 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/213 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.46%
1/218 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Gastrointestinal disorders
Duodenal hemorrhage
|
0.00%
0/213 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.46%
1/218 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Gastrointestinal disorders
Duodenal obstruction
|
0.47%
1/213 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.00%
0/218 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Blood and lymphatic system disorders
Anemia
|
8.0%
17/213 • Number of events 36 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
16.5%
36/218 • Number of events 84 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
0.47%
1/213 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.00%
0/218 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Cardiac disorders
Chest pain - cardiac
|
0.47%
1/213 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.00%
0/218 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Cardiac disorders
Sinus tachycardia
|
0.47%
1/213 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.46%
1/218 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Oth spec
|
0.00%
0/213 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
1.4%
3/218 • Number of events 4 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/213 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.46%
1/218 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Ear and labyrinth disorders
Vertigo
|
0.47%
1/213 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.00%
0/218 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/213 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.46%
1/218 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Eye disorders
Blurred vision
|
2.8%
6/213 • Number of events 11 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
1.4%
3/218 • Number of events 3 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Eye disorders
Eye disorders - Other, specify
|
0.00%
0/213 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.92%
2/218 • Number of events 5 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Eye disorders
Flashing lights
|
0.47%
1/213 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.00%
0/218 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Eye disorders
Periorbital edema
|
0.47%
1/213 • Number of events 2 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.46%
1/218 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Eye disorders
Watering eyes
|
0.00%
0/213 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.92%
2/218 • Number of events 2 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
General disorders
Gait disturbance
|
0.94%
2/213 • Number of events 10 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
1.8%
4/218 • Number of events 4 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
General disorders
Gen disord and admin site conds-Oth spec
|
1.4%
3/213 • Number of events 4 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
1.8%
4/218 • Number of events 4 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
General disorders
Neck edema
|
0.47%
1/213 • Number of events 2 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.00%
0/218 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
General disorders
Non-cardiac chest pain
|
0.47%
1/213 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.00%
0/218 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
General disorders
Pain
|
0.94%
2/213 • Number of events 2 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.92%
2/218 • Number of events 2 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Immune system disorders
Allergic reaction
|
0.94%
2/213 • Number of events 4 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.00%
0/218 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Infections and infestations
Anorectal infection
|
0.00%
0/213 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.46%
1/218 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Infections and infestations
Bladder infection
|
0.00%
0/213 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.46%
1/218 • Number of events 2 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Infections and infestations
Bronchial infection
|
0.00%
0/213 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.46%
1/218 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Infections and infestations
Infections and infestations - Oth spec
|
0.00%
0/213 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.92%
2/218 • Number of events 4 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Infections and infestations
Lung infection
|
0.00%
0/213 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.46%
1/218 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Infections and infestations
Mucosal infection
|
0.94%
2/213 • Number of events 3 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.46%
1/218 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Infections and infestations
Otitis media
|
0.00%
0/213 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.46%
1/218 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Infections and infestations
Papulopustular rash
|
0.00%
0/213 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.46%
1/218 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Infections and infestations
Penile infection
|
0.47%
1/213 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.00%
0/218 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/213 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.46%
1/218 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Infections and infestations
Skin infection
|
0.94%
2/213 • Number of events 2 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.46%
1/218 • Number of events 2 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Infections and infestations
Upper respiratory infection
|
0.47%
1/213 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.00%
0/218 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Infections and infestations
Urinary tract infection
|
0.47%
1/213 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.92%
2/218 • Number of events 2 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/213 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.46%
1/218 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Injury, poisoning and procedural complications
Bruising
|
0.94%
2/213 • Number of events 5 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
2.8%
6/218 • Number of events 11 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Injury, poisoning and procedural complications
Fall
|
2.3%
5/213 • Number of events 5 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
2.8%
6/218 • Number of events 6 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Injury, poisoning and procedural complications
Fracture
|
0.94%
2/213 • Number of events 4 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.00%
0/218 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Investigations
Alanine aminotransferase increased
|
1.4%
3/213 • Number of events 8 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
5.5%
12/218 • Number of events 20 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Investigations
Alkaline phosphatase increased
|
0.47%
1/213 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.92%
2/218 • Number of events 2 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Investigations
Aspartate aminotransferase increased
|
0.94%
2/213 • Number of events 5 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
2.3%
5/218 • Number of events 8 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Investigations
Blood bilirubin increased
|
0.47%
1/213 • Number of events 3 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
1.4%
3/218 • Number of events 8 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Investigations
CD4 lymphocytes decreased
|
0.47%
1/213 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.92%
2/218 • Number of events 2 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Investigations
Cardiac troponin I increased
|
0.00%
0/213 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.46%
1/218 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Investigations
Creatinine increased
|
1.4%
3/213 • Number of events 6 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
1.4%
3/218 • Number of events 4 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Investigations
Investigations - Other, specify
|
0.47%
1/213 • Number of events 5 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.92%
2/218 • Number of events 7 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Investigations
Lipase increased
|
0.47%
1/213 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.00%
0/218 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Investigations
Lymphocyte count decreased
|
28.2%
60/213 • Number of events 186 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
27.5%
60/218 • Number of events 177 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Investigations
Neutrophil count decreased
|
21.1%
45/213 • Number of events 93 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
52.8%
115/218 • Number of events 282 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Investigations
Platelet count decreased
|
54.5%
116/213 • Number of events 382 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
87.6%
191/218 • Number of events 667 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Investigations
Weight gain
|
0.94%
2/213 • Number of events 2 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
1.4%
3/218 • Number of events 8 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Investigations
Weight loss
|
4.2%
9/213 • Number of events 23 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
3.7%
8/218 • Number of events 22 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Investigations
White blood cell decreased
|
12.7%
27/213 • Number of events 61 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
28.4%
62/218 • Number of events 170 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/213 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.46%
1/218 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Metabolism and nutrition disorders
Anorexia
|
41.3%
88/213 • Number of events 244 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
38.1%
83/218 • Number of events 207 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.47%
1/213 • Number of events 2 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
1.4%
3/218 • Number of events 3 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
4.7%
10/213 • Number of events 24 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
7.3%
16/218 • Number of events 21 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/213 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.46%
1/218 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.47%
1/213 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.00%
0/218 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.47%
1/213 • Number of events 2 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.00%
0/218 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.94%
2/213 • Number of events 2 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
1.8%
4/218 • Number of events 6 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.47%
1/213 • Number of events 3 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
1.4%
3/218 • Number of events 4 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
1.4%
3/213 • Number of events 4 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
1.8%
4/218 • Number of events 4 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
1.4%
3/213 • Number of events 4 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
3.2%
7/218 • Number of events 8 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.47%
1/213 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.00%
0/218 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.94%
2/213 • Number of events 2 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.46%
1/218 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/213 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.46%
1/218 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Metabolism and nutrition disorders
Metabolism, nutrition disord - Oth spec
|
0.47%
1/213 • Number of events 2 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.00%
0/218 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Metabolism and nutrition disorders
Obesity
|
0.47%
1/213 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.00%
0/218 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.8%
6/213 • Number of events 13 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
2.3%
5/218 • Number of events 5 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.94%
2/213 • Number of events 2 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.00%
0/218 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.94%
2/213 • Number of events 2 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.46%
1/218 • Number of events 2 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
2.8%
6/213 • Number of events 10 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
3.7%
8/218 • Number of events 16 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
1.4%
3/213 • Number of events 6 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.46%
1/218 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
0.00%
0/213 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.46%
1/218 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal, conn tissue - Oth spec
|
0.94%
2/213 • Number of events 2 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.92%
2/218 • Number of events 4 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.47%
1/213 • Number of events 3 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.00%
0/218 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/213 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.46%
1/218 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.9%
4/213 • Number of events 5 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
1.4%
3/218 • Number of events 7 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Nervous system disorders
Amnesia
|
0.47%
1/213 • Number of events 4 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.46%
1/218 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Nervous system disorders
Ataxia
|
0.47%
1/213 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.92%
2/218 • Number of events 8 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Nervous system disorders
Cognitive disturbance
|
1.9%
4/213 • Number of events 4 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
1.8%
4/218 • Number of events 5 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Nervous system disorders
Concentration impairment
|
0.94%
2/213 • Number of events 7 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.46%
1/218 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/213 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.46%
1/218 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Nervous system disorders
Dizziness
|
4.2%
9/213 • Number of events 26 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
5.5%
12/218 • Number of events 20 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Nervous system disorders
Dysarthria
|
0.94%
2/213 • Number of events 5 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.46%
1/218 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Nervous system disorders
Dysgeusia
|
0.94%
2/213 • Number of events 5 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
3.2%
7/218 • Number of events 18 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Nervous system disorders
Dysphasia
|
0.94%
2/213 • Number of events 6 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
1.4%
3/218 • Number of events 3 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Nervous system disorders
Edema cerebral
|
0.47%
1/213 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.92%
2/218 • Number of events 2 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/213 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.46%
1/218 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Nervous system disorders
Headache
|
51.2%
109/213 • Number of events 328 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
45.4%
99/218 • Number of events 284 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Nervous system disorders
Hydrocephalus
|
0.47%
1/213 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.92%
2/218 • Number of events 2 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Nervous system disorders
Lethargy
|
0.94%
2/213 • Number of events 3 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
1.4%
3/218 • Number of events 3 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Nervous system disorders
Memory impairment
|
2.8%
6/213 • Number of events 13 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
4.6%
10/218 • Number of events 26 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Nervous system disorders
Muscle weakness left-sided
|
0.47%
1/213 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.46%
1/218 • Number of events 2 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Nervous system disorders
Muscle weakness right-sided
|
0.00%
0/213 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
2.3%
5/218 • Number of events 6 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Nervous system disorders
Nervous system disorders - Oth spec
|
0.94%
2/213 • Number of events 18 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
1.4%
3/218 • Number of events 23 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Nervous system disorders
Paresthesia
|
0.94%
2/213 • Number of events 2 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
1.4%
3/218 • Number of events 8 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/213 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.92%
2/218 • Number of events 3 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
1.4%
3/213 • Number of events 6 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.00%
0/218 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Nervous system disorders
Seizure
|
12.7%
27/213 • Number of events 44 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
13.8%
30/218 • Number of events 57 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Nervous system disorders
Somnolence
|
0.47%
1/213 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.00%
0/218 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Nervous system disorders
Stroke
|
0.00%
0/213 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.92%
2/218 • Number of events 2 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Nervous system disorders
Syncope
|
0.00%
0/213 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.46%
1/218 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Nervous system disorders
Tremor
|
0.94%
2/213 • Number of events 7 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.46%
1/218 • Number of events 2 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Psychiatric disorders
Agitation
|
0.47%
1/213 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.00%
0/218 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Psychiatric disorders
Anxiety
|
0.94%
2/213 • Number of events 2 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
1.8%
4/218 • Number of events 7 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Psychiatric disorders
Confusion
|
1.9%
4/213 • Number of events 6 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
1.8%
4/218 • Number of events 8 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Psychiatric disorders
Depression
|
1.4%
3/213 • Number of events 6 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.46%
1/218 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Psychiatric disorders
Hallucinations
|
0.47%
1/213 • Number of events 2 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.00%
0/218 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Psychiatric disorders
Insomnia
|
1.9%
4/213 • Number of events 6 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.92%
2/218 • Number of events 2 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Psychiatric disorders
Personality change
|
0.47%
1/213 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.00%
0/218 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
0.00%
0/213 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
1.4%
3/218 • Number of events 7 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/213 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.46%
1/218 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/213 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.46%
1/218 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Renal and urinary disorders
Renal and urinary disorders - Oth spec
|
0.47%
1/213 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
1.4%
3/218 • Number of events 3 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Renal and urinary disorders
Urinary frequency
|
0.47%
1/213 • Number of events 2 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.92%
2/218 • Number of events 4 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Renal and urinary disorders
Urinary incontinence
|
0.94%
2/213 • Number of events 2 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
1.8%
4/218 • Number of events 4 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Renal and urinary disorders
Urinary urgency
|
0.00%
0/213 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.46%
1/218 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Reproductive system and breast disorders
Testicular disorder
|
0.47%
1/213 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.00%
0/218 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.47%
1/213 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.00%
0/218 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/213 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.92%
2/218 • Number of events 2 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/213 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
1.4%
3/218 • Number of events 7 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/213 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.92%
2/218 • Number of events 6 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/213 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.46%
1/218 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/213 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.46%
1/218 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic, mediastinal - Oth spec
|
0.00%
0/213 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
1.4%
3/218 • Number of events 3 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.94%
2/213 • Number of events 3 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
3.7%
8/218 • Number of events 9 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.47%
1/213 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
1.4%
3/218 • Number of events 3 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.47%
1/213 • Number of events 2 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.00%
0/218 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.4%
3/213 • Number of events 3 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
1.4%
3/218 • Number of events 4 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
1.9%
4/213 • Number of events 6 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
3.7%
8/218 • Number of events 11 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcut tissue disord - Oth spec
|
0.94%
2/213 • Number of events 3 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
1.8%
4/218 • Number of events 7 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.47%
1/213 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.46%
1/218 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Surgical and medical procedures
Surgical and medical proced - Oth spec
|
0.00%
0/213 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.46%
1/218 • Number of events 2 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Vascular disorders
Flushing
|
0.47%
1/213 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.46%
1/218 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Vascular disorders
Hematoma
|
0.00%
0/213 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.46%
1/218 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Vascular disorders
Hot flashes
|
0.00%
0/213 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.46%
1/218 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Vascular disorders
Hypertension
|
3.3%
7/213 • Number of events 16 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
2.8%
6/218 • Number of events 15 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Vascular disorders
Hypotension
|
0.94%
2/213 • Number of events 2 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.00%
0/218 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Vascular disorders
Superficial thrombophlebitis
|
0.00%
0/213 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.46%
1/218 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Vascular disorders
Thromboembolic event
|
1.9%
4/213 • Number of events 10 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.92%
2/218 • Number of events 2 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
|
Vascular disorders
Vascular disorders - Other, specify
|
0.00%
0/213 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
0.46%
1/218 • Number of events 1 • All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60