Trial Outcomes & Findings for Testing the Addition of a New Anti-cancer Drug, Venetoclax, to the Usual Treatment (Ibrutinib and Obinutuzumab) in Untreated, Older Patients With Chronic Lymphocytic Leukemia (NCT NCT03737981)
NCT ID: NCT03737981
Last Updated: 2026-05-01
Results Overview
PFS will be compared between the experimental and control treatment strategy groups using a stratified log-rank test (stratified on Rai stage, intermediate versus \[vs.\] high, and del(17p13.1) by fluorescence in situ hybridization \[FISH\], present vs. absent). The Kaplan-Meier method will be used to estimate PFS distributions. Five-year PFS estimates and corresponding hazard ratios will be provided with 95% confidence intervals for each treatment strategy.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
465 participants
Primary outcome timeframe
5 years
Results posted on
2026-05-01
Participant Flow
534 patients were pre-registered, 465 went on to register and were randomized to treatment
Participant milestones
| Measure |
Arm I (Ibrutinib, Obinutuzumab)
Patients receive ibrutinib PO QD on days 1-28. Patients also receive obinutuzumab IV on days 1, 2, 8, and 15 of cycle 1, and on day 1 of cycles 2-6. Treatment repeats every 28 days for up to 14 cycles in the absence of disease progression or unacceptable toxicity. Beginning cycle 15, patients receive ibrutinib PO QD every 28 days in the absence of disease progression or unacceptable toxicity.
\>
\> Ibrutinib: Given PO
\>
\> Obinutuzumab: Given IV
|
Arm II (Ibrutinib, Obinutuzumab, Venetoclax)
Patients receive ibrutinib PO QD on days 1-28. Patients also receive obinutuzumab IV on days 1, 2, 8, and 15 of cycle 1, and on day 1 of cycles 2-6. Beginning cycle 3, patients also receive venetoclax PO QD on days 1-28. Treatment repeats every 28 days for 14 cycles in the absence of disease progression or unacceptable toxicity. All patients will then receive a 15th cycle of ibrutinib. Beginning cycle 16, patients who do not achieve a BM MRD negative CR, receive ibrutinib PO QD every 28 days in the absence of disease progression or unacceptable toxicity. Patients who achieve a BM MRD negative CR undergo observation every 3 cycles for 6 years, then every 6 cycles thereafter.
\>
\> Ibrutinib: Given PO
\>
\> Obinutuzumab: Given IV
\>
\> Observation Activity: Undergo observation
\>
\> Venetoclax: Given PO
|
|---|---|---|
|
Initial Treatment
STARTED
|
232
|
233
|
|
Initial Treatment
COMPLETED
|
166
|
158
|
|
Initial Treatment
NOT COMPLETED
|
66
|
75
|
|
Subsequent Ibrutinib/Observation
STARTED
|
166
|
158
|
|
Subsequent Ibrutinib/Observation
COMPLETED
|
0
|
2
|
|
Subsequent Ibrutinib/Observation
NOT COMPLETED
|
166
|
156
|
Reasons for withdrawal
| Measure |
Arm I (Ibrutinib, Obinutuzumab)
Patients receive ibrutinib PO QD on days 1-28. Patients also receive obinutuzumab IV on days 1, 2, 8, and 15 of cycle 1, and on day 1 of cycles 2-6. Treatment repeats every 28 days for up to 14 cycles in the absence of disease progression or unacceptable toxicity. Beginning cycle 15, patients receive ibrutinib PO QD every 28 days in the absence of disease progression or unacceptable toxicity.
\>
\> Ibrutinib: Given PO
\>
\> Obinutuzumab: Given IV
|
Arm II (Ibrutinib, Obinutuzumab, Venetoclax)
Patients receive ibrutinib PO QD on days 1-28. Patients also receive obinutuzumab IV on days 1, 2, 8, and 15 of cycle 1, and on day 1 of cycles 2-6. Beginning cycle 3, patients also receive venetoclax PO QD on days 1-28. Treatment repeats every 28 days for 14 cycles in the absence of disease progression or unacceptable toxicity. All patients will then receive a 15th cycle of ibrutinib. Beginning cycle 16, patients who do not achieve a BM MRD negative CR, receive ibrutinib PO QD every 28 days in the absence of disease progression or unacceptable toxicity. Patients who achieve a BM MRD negative CR undergo observation every 3 cycles for 6 years, then every 6 cycles thereafter.
\>
\> Ibrutinib: Given PO
\>
\> Obinutuzumab: Given IV
\>
\> Observation Activity: Undergo observation
\>
\> Venetoclax: Given PO
|
|---|---|---|
|
Initial Treatment
Withdrawal by Subject
|
6
|
9
|
|
Initial Treatment
Adverse Event
|
32
|
22
|
|
Initial Treatment
Disease progression
|
1
|
4
|
|
Initial Treatment
Alternative therapy
|
1
|
1
|
|
Initial Treatment
Complicating disease
|
8
|
6
|
|
Initial Treatment
Death
|
11
|
15
|
|
Initial Treatment
Patient withdrawal prior to treatment
|
1
|
2
|
|
Initial Treatment
Patient not on Ibrutinib
|
0
|
1
|
|
Initial Treatment
Patient moved
|
0
|
1
|
|
Initial Treatment
Patient ineligible
|
0
|
1
|
|
Initial Treatment
Physician Decision
|
2
|
2
|
|
Initial Treatment
Death prior to treatment
|
0
|
1
|
|
Initial Treatment
Patient inability to follow protocol
|
0
|
1
|
|
Initial Treatment
Other
|
4
|
9
|
|
Subsequent Ibrutinib/Observation
Withdrawal by Subject
|
11
|
7
|
|
Subsequent Ibrutinib/Observation
Adverse Event
|
38
|
12
|
|
Subsequent Ibrutinib/Observation
Disease progression
|
3
|
3
|
|
Subsequent Ibrutinib/Observation
Alternative therapy
|
1
|
2
|
|
Subsequent Ibrutinib/Observation
Complicating disease
|
4
|
5
|
|
Subsequent Ibrutinib/Observation
Death
|
13
|
16
|
|
Subsequent Ibrutinib/Observation
Other
|
2
|
7
|
|
Subsequent Ibrutinib/Observation
On treatment
|
90
|
101
|
|
Subsequent Ibrutinib/Observation
Physician Decision
|
3
|
1
|
|
Subsequent Ibrutinib/Observation
Clinical response
|
1
|
1
|
|
Subsequent Ibrutinib/Observation
VA denial of authorization
|
0
|
1
|
Baseline Characteristics
Testing the Addition of a New Anti-cancer Drug, Venetoclax, to the Usual Treatment (Ibrutinib and Obinutuzumab) in Untreated, Older Patients With Chronic Lymphocytic Leukemia
Baseline characteristics by cohort
| Measure |
Arm I (Ibrutinib, Obinutuzumab)
n=232 Participants
Patients receive ibrutinib PO QD on days 1-28. Patients also receive obinutuzumab IV on days 1, 2, 8, and 15 of cycle 1, and on day 1 of cycles 2-6. Treatment repeats every 28 days for up to 14 cycles in the absence of disease progression or unacceptable toxicity. Beginning cycle 15, patients receive ibrutinib PO QD every 28 days in the absence of disease progression or unacceptable toxicity.\> \> Ibrutinib: Given PO\>
\> Obinutuzumab: Given IV
|
Arm II (Ibrutinib, Obinutuzumab, Venetoclax)
n=233 Participants
Patients receive ibrutinib PO QD on days 1-28. Patients also receive obinutuzumab IV on days 1, 2, 8, and 15 of cycle 1, and on day 1 of cycles 2-6. Beginning cycle 3, patients also receive venetoclax PO QD on days 1-28. Treatment repeats every 28 days for 14 cycles in the absence of disease progression or unacceptable toxicity. All patients will then receive a 15th cycle of ibrutinib. Beginning cycle 16, patients who do not achieve a BM MRD negative CR, receive ibrutinib PO QD every 28 days in the absence of disease progression or unacceptable toxicity. Patients who achieve a BM MRD negative CR undergo observation every 3 cycles for 6 years, then every 6 cycles thereafter.\> \> Ibrutinib: Given PO\>
\> Obinutuzumab: Given IV\>
\> Observation Activity: Undergo observation\>
\> Venetoclax: Given PO
|
Total
n=465 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
|
Age, Continuous
|
74 years
n=14 Participants
|
74 years
n=34 Participants
|
74 years
n=69 Participants
|
|
Sex: Female, Male
Female
|
69 Participants
n=14 Participants
|
82 Participants
n=34 Participants
|
151 Participants
n=69 Participants
|
|
Sex: Female, Male
Male
|
163 Participants
n=14 Participants
|
151 Participants
n=34 Participants
|
314 Participants
n=69 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=14 Participants
|
3 Participants
n=34 Participants
|
4 Participants
n=69 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
218 Participants
n=14 Participants
|
223 Participants
n=34 Participants
|
441 Participants
n=69 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
13 Participants
n=14 Participants
|
7 Participants
n=34 Participants
|
20 Participants
n=69 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=14 Participants
|
1 Participants
n=34 Participants
|
1 Participants
n=69 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=14 Participants
|
1 Participants
n=34 Participants
|
2 Participants
n=69 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=14 Participants
|
16 Participants
n=34 Participants
|
24 Participants
n=69 Participants
|
|
Race (NIH/OMB)
White
|
214 Participants
n=14 Participants
|
210 Participants
n=34 Participants
|
424 Participants
n=69 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=14 Participants
|
1 Participants
n=34 Participants
|
1 Participants
n=69 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=14 Participants
|
4 Participants
n=34 Participants
|
13 Participants
n=69 Participants
|
|
Region of Enrollment
United States
|
232 participants
n=14 Participants
|
233 participants
n=34 Participants
|
465 participants
n=69 Participants
|
|
Rai Stage classification category
High
|
129 Participants
n=14 Participants
|
129 Participants
n=34 Participants
|
258 Participants
n=69 Participants
|
|
Rai Stage classification category
Intermediate
|
103 Participants
n=14 Participants
|
104 Participants
n=34 Participants
|
207 Participants
n=69 Participants
|
|
ECOG Performance Status
0
|
119 Participants
n=14 Participants
|
114 Participants
n=34 Participants
|
233 Participants
n=69 Participants
|
|
ECOG Performance Status
1
|
106 Participants
n=14 Participants
|
111 Participants
n=34 Participants
|
217 Participants
n=69 Participants
|
|
ECOG Performance Status
2
|
7 Participants
n=14 Participants
|
8 Participants
n=34 Participants
|
15 Participants
n=69 Participants
|
|
High-risk FISH abnormality del(17p13.1)
Absent
|
202 Participants
n=14 Participants
|
202 Participants
n=34 Participants
|
404 Participants
n=69 Participants
|
|
High-risk FISH abnormality del(17p13.1)
Present
|
30 Participants
n=14 Participants
|
31 Participants
n=34 Participants
|
61 Participants
n=69 Participants
|
PRIMARY outcome
Timeframe: 5 yearsPFS will be compared between the experimental and control treatment strategy groups using a stratified log-rank test (stratified on Rai stage, intermediate versus \[vs.\] high, and del(17p13.1) by fluorescence in situ hybridization \[FISH\], present vs. absent). The Kaplan-Meier method will be used to estimate PFS distributions. Five-year PFS estimates and corresponding hazard ratios will be provided with 95% confidence intervals for each treatment strategy.
Outcome measures
| Measure |
Arm I (Ibrutinib, Obinutuzumab)
n=232 Participants
Patients receive ibrutinib PO QD on days 1-28. Patients also receive obinutuzumab IV on days 1, 2, 8, and 15 of cycle 1, and on day 1 of cycles 2-6. Treatment repeats every 28 days for up to 14 cycles in the absence of disease progression or unacceptable toxicity. Beginning cycle 15, patients receive ibrutinib PO QD every 28 days in the absence of disease progression or unacceptable toxicity.\> \> Ibrutinib: Given PO\>
\> Obinutuzumab: Given IV
|
Arm II (Ibrutinib, Obinutuzumab, Venetoclax)
n=233 Participants
Patients receive ibrutinib PO QD on days 1-28. Patients also receive obinutuzumab IV on days 1, 2, 8, and 15 of cycle 1, and on day 1 of cycles 2-6. Beginning cycle 3, patients also receive venetoclax PO QD on days 1-28. Treatment repeats every 28 days for 14 cycles in the absence of disease progression or unacceptable toxicity. All patients will then receive a 15th cycle of ibrutinib. Beginning cycle 16, patients who do not achieve a BM MRD negative CR, receive ibrutinib PO QD every 28 days in the absence of disease progression or unacceptable toxicity. Patients who achieve a BM MRD negative CR undergo observation every 3 cycles for 6 years, then every 6 cycles thereafter.\> \> Ibrutinib: Given PO\>
\> Obinutuzumab: Given IV\>
\> Observation Activity: Undergo observation\>
\> Venetoclax: Given PO
|
|---|---|---|
|
Progression-free Survival (PFS)
|
0.59 proportion of participants w/out event
Interval 0.51 to 0.67
|
0.68 proportion of participants w/out event
Interval 0.61 to 0.75
|
SECONDARY outcome
Timeframe: Up to 10 yearsBM MRD- CR rate will be calculated and will be estimated using the number of patients meeting the BM MRD- CR criteria divided by the total number of patients randomized to each of the treatment arms. The stratified Cochran-Mantel-Haenszel test will be used to compare the BM MRD- CR rates between treatment arms (stratified on Rai stage, intermediate vs. high, and del(17p13.1) by FISH, present vs. absent).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From randomization date until death from any cause, assessed up to 10 yearsThe Kaplan-Meier method will be used to estimate the OS distribution for each treatment strategy. Estimates at 5 years will be calculated with corresponding 95% confidence intervals, and differences in these estimates between the treatment strategies will be tested using a stratified chi-square test based on the complementary log-log transformation of the Kaplan-Meier estimates. Comparisons in OS curves between experimental and control treatment strategies will use a stratified log-rank test (stratified on Rai stage, intermediate vs. high, and del(17p13.1) by FISH, present vs. absent). Hazard ratios with 95% confidence intervals will be estimated from the corresponding, stratified proportional hazard model.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 10 yearsWill be defined as adverse events that are classified as either possibly, probably, or definitely related to study treatment, graded per National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Frequency and severity of adverse events and tolerability for each treatment strategy group will be summarized using descriptive statistics. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns. The incidence of severe (grade 3+) adverse events or toxicities will be described.
Outcome measures
Outcome data not reported
Adverse Events
Arm I (Ibrutinib, Obinutuzumab)
Serious events: 0 serious events
Other events: 229 other events
Deaths: 11 deaths
Arm II (Ibrutinib, Obinutuzumab, Venetoclax)
Serious events: 0 serious events
Other events: 230 other events
Deaths: 15 deaths
Subsequent Treatment - Ibrutinib
Serious events: 0 serious events
Other events: 213 other events
Deaths: 20 deaths
Subsequent Treatment - Observation
Serious events: 0 serious events
Other events: 104 other events
Deaths: 9 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm I (Ibrutinib, Obinutuzumab)
n=232 participants at risk
Ibrutinib 420 mg PO daily days 1-28 for 15 cycles Obinutuzumab 100 mg IV 100 mg on C1D1, 900 mg on C1D2, 1000 mg on Cycle1D8 \& C1D15, C2-6D1
|
Arm II (Ibrutinib, Obinutuzumab, Venetoclax)
n=233 participants at risk
Ibrutinib 420 mg PO daily days 1-28 for 15 cycles Obinutuzumab 100 mg IV 100 mg on C1D1, 900 mg on C1D2, 1000 mg on C1D8 \& C1D15, C2-6D1 Venetoclax 20 mg daily PO beginning C3D1, dose escalated weekly to a final dose of 400 mg on C4D1, then 400 mg daily PO C4D1-C14D28
|
Subsequent Treatment - Ibrutinib
n=219 participants at risk
Ibrutinib 420 mg PO daily days 1-28 until progression or unacceptable adverse events
|
Subsequent Treatment - Observation
n=105 participants at risk
q3 cycles for 6 years from registration, then q6 cycles until progression
|
|---|---|---|---|---|
|
Infections and infestations
Tooth infection
|
1.7%
4/232 • Number of events 6 • 6.75 years
|
0.43%
1/233 • Number of events 1 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.95%
1/105 • Number of events 1 • 6.75 years
|
|
Infections and infestations
Upper respiratory infection
|
4.3%
10/232 • Number of events 15 • 6.75 years
|
3.9%
9/233 • Number of events 15 • 6.75 years
|
8.2%
18/219 • Number of events 29 • 6.75 years
|
8.6%
9/105 • Number of events 15 • 6.75 years
|
|
Infections and infestations
Urinary tract infection
|
9.5%
22/232 • Number of events 33 • 6.75 years
|
6.9%
16/233 • Number of events 26 • 6.75 years
|
11.0%
24/219 • Number of events 32 • 6.75 years
|
2.9%
3/105 • Number of events 3 • 6.75 years
|
|
Infections and infestations
Vaginal infection
|
0.43%
1/232 • Number of events 1 • 6.75 years
|
0.43%
1/233 • Number of events 2 • 6.75 years
|
0.91%
2/219 • Number of events 2 • 6.75 years
|
0.95%
1/105 • Number of events 1 • 6.75 years
|
|
Infections and infestations
Viremia
|
0.00%
0/232 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.46%
1/219 • Number of events 1 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Infections and infestations
Wound infection
|
1.3%
3/232 • Number of events 4 • 6.75 years
|
1.7%
4/233 • Number of events 5 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Injury, poisoning and procedural complications
Bruising
|
59.1%
137/232 • Number of events 612 • 6.75 years
|
61.4%
143/233 • Number of events 673 • 6.75 years
|
61.6%
135/219 • Number of events 997 • 6.75 years
|
42.9%
45/105 • Number of events 181 • 6.75 years
|
|
Injury, poisoning and procedural complications
Burn
|
0.43%
1/232 • Number of events 2 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Injury, poisoning and procedural complications
Fall
|
5.2%
12/232 • Number of events 16 • 6.75 years
|
6.9%
16/233 • Number of events 18 • 6.75 years
|
10.0%
22/219 • Number of events 30 • 6.75 years
|
5.7%
6/105 • Number of events 7 • 6.75 years
|
|
Injury, poisoning and procedural complications
Fracture
|
0.86%
2/232 • Number of events 2 • 6.75 years
|
2.6%
6/233 • Number of events 9 • 6.75 years
|
4.6%
10/219 • Number of events 13 • 6.75 years
|
0.95%
1/105 • Number of events 1 • 6.75 years
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.43%
1/232 • Number of events 1 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.91%
2/219 • Number of events 2 • 6.75 years
|
0.95%
1/105 • Number of events 1 • 6.75 years
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
13.8%
32/232 • Number of events 34 • 6.75 years
|
13.3%
31/233 • Number of events 34 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Injury, poisoning and procedural complications
Inj, pois and proced complic - Oth spec
|
1.3%
3/232 • Number of events 3 • 6.75 years
|
1.3%
3/233 • Number of events 5 • 6.75 years
|
2.7%
6/219 • Number of events 9 • 6.75 years
|
3.8%
4/105 • Number of events 16 • 6.75 years
|
|
Injury, poisoning and procedural complications
Injury to jugular vein
|
0.00%
0/232 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.46%
1/219 • Number of events 2 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Injury, poisoning and procedural complications
Intraoperative musculoskeletal injury
|
0.00%
0/232 • 6.75 years
|
0.43%
1/233 • Number of events 1 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Injury, poisoning and procedural complications
Postoperative hemorrhage
|
0.43%
1/232 • Number of events 2 • 6.75 years
|
0.43%
1/233 • Number of events 3 • 6.75 years
|
0.46%
1/219 • Number of events 1 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/232 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.46%
1/219 • Number of events 2 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.43%
1/232 • Number of events 2 • 6.75 years
|
0.43%
1/233 • Number of events 1 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
1.9%
2/105 • Number of events 2 • 6.75 years
|
|
Injury, poisoning and procedural complications
Urethral anastomotic leak
|
0.00%
0/232 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.95%
1/105 • Number of events 1 • 6.75 years
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
0.86%
2/232 • Number of events 2 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/232 • 6.75 years
|
0.43%
1/233 • Number of events 1 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.95%
1/105 • Number of events 1 • 6.75 years
|
|
Investigations
Activated partial throm time prolonged
|
0.86%
2/232 • Number of events 2 • 6.75 years
|
1.3%
3/233 • Number of events 3 • 6.75 years
|
0.46%
1/219 • Number of events 2 • 6.75 years
|
0.95%
1/105 • Number of events 1 • 6.75 years
|
|
Investigations
Alanine aminotransferase increased
|
5.2%
12/232 • Number of events 20 • 6.75 years
|
11.2%
26/233 • Number of events 40 • 6.75 years
|
8.2%
18/219 • Number of events 33 • 6.75 years
|
2.9%
3/105 • Number of events 11 • 6.75 years
|
|
Investigations
Alkaline phosphatase increased
|
6.0%
14/232 • Number of events 19 • 6.75 years
|
9.0%
21/233 • Number of events 47 • 6.75 years
|
8.2%
18/219 • Number of events 40 • 6.75 years
|
3.8%
4/105 • Number of events 20 • 6.75 years
|
|
Investigations
Aspartate aminotransferase increased
|
9.9%
23/232 • Number of events 36 • 6.75 years
|
12.0%
28/233 • Number of events 45 • 6.75 years
|
9.1%
20/219 • Number of events 55 • 6.75 years
|
3.8%
4/105 • Number of events 6 • 6.75 years
|
|
Investigations
Blood bilirubin increased
|
11.6%
27/232 • Number of events 59 • 6.75 years
|
15.9%
37/233 • Number of events 87 • 6.75 years
|
12.3%
27/219 • Number of events 96 • 6.75 years
|
12.4%
13/105 • Number of events 46 • 6.75 years
|
|
Investigations
Blood lactate dehydrogenase increased
|
12.9%
30/232 • Number of events 60 • 6.75 years
|
15.0%
35/233 • Number of events 68 • 6.75 years
|
9.6%
21/219 • Number of events 70 • 6.75 years
|
6.7%
7/105 • Number of events 16 • 6.75 years
|
|
Investigations
CD4 lymphocytes decreased
|
0.00%
0/232 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.46%
1/219 • Number of events 1 • 6.75 years
|
1.9%
2/105 • Number of events 8 • 6.75 years
|
|
Investigations
Cardiac troponin I increased
|
1.3%
3/232 • Number of events 3 • 6.75 years
|
1.3%
3/233 • Number of events 3 • 6.75 years
|
1.8%
4/219 • Number of events 4 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Investigations
Cardiac troponin T increased
|
0.86%
2/232 • Number of events 2 • 6.75 years
|
0.86%
2/233 • Number of events 2 • 6.75 years
|
1.8%
4/219 • Number of events 5 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Investigations
Cholesterol high
|
0.86%
2/232 • Number of events 3 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.91%
2/219 • Number of events 5 • 6.75 years
|
3.8%
4/105 • Number of events 10 • 6.75 years
|
|
Investigations
Creatinine increased
|
17.7%
41/232 • Number of events 107 • 6.75 years
|
18.0%
42/233 • Number of events 109 • 6.75 years
|
26.9%
59/219 • Number of events 248 • 6.75 years
|
17.1%
18/105 • Number of events 69 • 6.75 years
|
|
Investigations
ECG QT corrected interval prolonged
|
0.00%
0/232 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.95%
1/105 • Number of events 13 • 6.75 years
|
|
Investigations
Ejection fraction decreased
|
0.43%
1/232 • Number of events 2 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
1.4%
3/219 • Number of events 3 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Investigations
Hemoglobin increased
|
1.3%
3/232 • Number of events 6 • 6.75 years
|
0.43%
1/233 • Number of events 3 • 6.75 years
|
0.46%
1/219 • Number of events 5 • 6.75 years
|
0.95%
1/105 • Number of events 1 • 6.75 years
|
|
Investigations
INR increased
|
2.2%
5/232 • Number of events 11 • 6.75 years
|
3.4%
8/233 • Number of events 18 • 6.75 years
|
3.2%
7/219 • Number of events 26 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Investigations
Investigations - Other, specify
|
1.7%
4/232 • Number of events 18 • 6.75 years
|
3.9%
9/233 • Number of events 15 • 6.75 years
|
6.4%
14/219 • Number of events 71 • 6.75 years
|
10.5%
11/105 • Number of events 57 • 6.75 years
|
|
Investigations
Lipase increased
|
0.43%
1/232 • Number of events 1 • 6.75 years
|
0.86%
2/233 • Number of events 8 • 6.75 years
|
1.8%
4/219 • Number of events 16 • 6.75 years
|
0.95%
1/105 • Number of events 3 • 6.75 years
|
|
Investigations
Lymphocyte count decreased
|
17.7%
41/232 • Number of events 107 • 6.75 years
|
36.5%
85/233 • Number of events 284 • 6.75 years
|
27.9%
61/219 • Number of events 233 • 6.75 years
|
33.3%
35/105 • Number of events 133 • 6.75 years
|
|
Investigations
Lymphocyte count increased
|
21.6%
50/232 • Number of events 123 • 6.75 years
|
20.6%
48/233 • Number of events 81 • 6.75 years
|
6.4%
14/219 • Number of events 35 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Investigations
Neutrophil count decreased
|
49.6%
115/232 • Number of events 290 • 6.75 years
|
66.5%
155/233 • Number of events 510 • 6.75 years
|
21.0%
46/219 • Number of events 117 • 6.75 years
|
21.9%
23/105 • Number of events 64 • 6.75 years
|
|
Investigations
Platelet count decreased
|
70.3%
163/232 • Number of events 639 • 6.75 years
|
76.8%
179/233 • Number of events 872 • 6.75 years
|
46.6%
102/219 • Number of events 677 • 6.75 years
|
39.0%
41/105 • Number of events 168 • 6.75 years
|
|
Investigations
Serum amylase increased
|
0.00%
0/232 • 6.75 years
|
0.43%
1/233 • Number of events 2 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Investigations
Thyroid stimulating hormone increased
|
1.3%
3/232 • Number of events 4 • 6.75 years
|
0.86%
2/233 • Number of events 2 • 6.75 years
|
0.91%
2/219 • Number of events 2 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Investigations
Urine output decreased
|
0.00%
0/232 • 6.75 years
|
0.43%
1/233 • Number of events 1 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Investigations
Weight gain
|
3.4%
8/232 • Number of events 22 • 6.75 years
|
3.0%
7/233 • Number of events 19 • 6.75 years
|
5.0%
11/219 • Number of events 62 • 6.75 years
|
4.8%
5/105 • Number of events 23 • 6.75 years
|
|
Investigations
Weight loss
|
4.3%
10/232 • Number of events 23 • 6.75 years
|
7.7%
18/233 • Number of events 36 • 6.75 years
|
7.8%
17/219 • Number of events 43 • 6.75 years
|
8.6%
9/105 • Number of events 29 • 6.75 years
|
|
Investigations
White blood cell decreased
|
13.4%
31/232 • Number of events 71 • 6.75 years
|
39.9%
93/233 • Number of events 277 • 6.75 years
|
13.2%
29/219 • Number of events 69 • 6.75 years
|
16.2%
17/105 • Number of events 54 • 6.75 years
|
|
Metabolism and nutrition disorders
Acidosis
|
0.86%
2/232 • Number of events 2 • 6.75 years
|
0.43%
1/233 • Number of events 1 • 6.75 years
|
0.91%
2/219 • Number of events 2 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Metabolism and nutrition disorders
Alkalosis
|
0.00%
0/232 • 6.75 years
|
0.43%
1/233 • Number of events 1 • 6.75 years
|
0.46%
1/219 • Number of events 1 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Metabolism and nutrition disorders
Anorexia
|
6.5%
15/232 • Number of events 21 • 6.75 years
|
14.2%
33/233 • Number of events 62 • 6.75 years
|
6.4%
14/219 • Number of events 18 • 6.75 years
|
2.9%
3/105 • Number of events 9 • 6.75 years
|
|
Metabolism and nutrition disorders
Blood bicarbonate decreased
|
0.43%
1/232 • Number of events 3 • 6.75 years
|
0.43%
1/233 • Number of events 1 • 6.75 years
|
1.8%
4/219 • Number of events 4 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Metabolism and nutrition disorders
Dehydration
|
4.3%
10/232 • Number of events 10 • 6.75 years
|
3.4%
8/233 • Number of events 10 • 6.75 years
|
1.8%
4/219 • Number of events 5 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
0.86%
2/232 • Number of events 6 • 6.75 years
|
0.43%
1/233 • Number of events 1 • 6.75 years
|
0.91%
2/219 • Number of events 5 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.86%
2/232 • Number of events 2 • 6.75 years
|
3.0%
7/233 • Number of events 8 • 6.75 years
|
1.8%
4/219 • Number of events 8 • 6.75 years
|
2.9%
3/105 • Number of events 6 • 6.75 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
20.3%
47/232 • Number of events 126 • 6.75 years
|
19.3%
45/233 • Number of events 103 • 6.75 years
|
23.3%
51/219 • Number of events 175 • 6.75 years
|
23.8%
25/105 • Number of events 82 • 6.75 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
8.6%
20/232 • Number of events 36 • 6.75 years
|
6.9%
16/233 • Number of events 18 • 6.75 years
|
7.8%
17/219 • Number of events 34 • 6.75 years
|
4.8%
5/105 • Number of events 7 • 6.75 years
|
|
Metabolism and nutrition disorders
Hyperlipidemia
|
1.3%
3/232 • Number of events 5 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.91%
2/219 • Number of events 2 • 6.75 years
|
1.9%
2/105 • Number of events 3 • 6.75 years
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.43%
1/232 • Number of events 1 • 6.75 years
|
0.86%
2/233 • Number of events 2 • 6.75 years
|
0.91%
2/219 • Number of events 2 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Metabolism and nutrition disorders
Hypernatremia
|
2.2%
5/232 • Number of events 11 • 6.75 years
|
4.7%
11/233 • Number of events 16 • 6.75 years
|
3.2%
7/219 • Number of events 9 • 6.75 years
|
4.8%
5/105 • Number of events 9 • 6.75 years
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
4.7%
11/232 • Number of events 21 • 6.75 years
|
10.3%
24/233 • Number of events 43 • 6.75 years
|
1.4%
3/219 • Number of events 5 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.86%
2/232 • Number of events 7 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.91%
2/219 • Number of events 15 • 6.75 years
|
0.95%
1/105 • Number of events 2 • 6.75 years
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
6.5%
15/232 • Number of events 22 • 6.75 years
|
5.2%
12/233 • Number of events 15 • 6.75 years
|
4.6%
10/219 • Number of events 27 • 6.75 years
|
2.9%
3/105 • Number of events 11 • 6.75 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
13.4%
31/232 • Number of events 54 • 6.75 years
|
14.2%
33/233 • Number of events 76 • 6.75 years
|
14.2%
31/219 • Number of events 68 • 6.75 years
|
4.8%
5/105 • Number of events 14 • 6.75 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
9.9%
23/232 • Number of events 40 • 6.75 years
|
15.9%
37/233 • Number of events 61 • 6.75 years
|
11.4%
25/219 • Number of events 49 • 6.75 years
|
5.7%
6/105 • Number of events 12 • 6.75 years
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
6.9%
16/232 • Number of events 26 • 6.75 years
|
4.3%
10/233 • Number of events 18 • 6.75 years
|
3.7%
8/219 • Number of events 13 • 6.75 years
|
3.8%
4/105 • Number of events 10 • 6.75 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
4.7%
11/232 • Number of events 26 • 6.75 years
|
12.4%
29/233 • Number of events 63 • 6.75 years
|
7.3%
16/219 • Number of events 23 • 6.75 years
|
4.8%
5/105 • Number of events 15 • 6.75 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
1.7%
4/232 • Number of events 11 • 6.75 years
|
5.2%
12/233 • Number of events 36 • 6.75 years
|
3.2%
7/219 • Number of events 30 • 6.75 years
|
1.9%
2/105 • Number of events 3 • 6.75 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
12.9%
30/232 • Number of events 64 • 6.75 years
|
16.7%
39/233 • Number of events 75 • 6.75 years
|
13.7%
30/219 • Number of events 67 • 6.75 years
|
6.7%
7/105 • Number of events 20 • 6.75 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
2.6%
6/232 • Number of events 6 • 6.75 years
|
7.7%
18/233 • Number of events 24 • 6.75 years
|
2.7%
6/219 • Number of events 12 • 6.75 years
|
1.9%
2/105 • Number of events 6 • 6.75 years
|
|
Metabolism and nutrition disorders
Metabolism, nutrition disord - Oth spec
|
0.86%
2/232 • Number of events 5 • 6.75 years
|
1.7%
4/233 • Number of events 13 • 6.75 years
|
2.3%
5/219 • Number of events 6 • 6.75 years
|
1.9%
2/105 • Number of events 2 • 6.75 years
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/232 • 6.75 years
|
0.43%
1/233 • Number of events 8 • 6.75 years
|
0.46%
1/219 • Number of events 19 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
1.7%
4/232 • Number of events 4 • 6.75 years
|
4.7%
11/233 • Number of events 11 • 6.75 years
|
0.91%
2/219 • Number of events 2 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
38.8%
90/232 • Number of events 358 • 6.75 years
|
46.8%
109/233 • Number of events 510 • 6.75 years
|
44.3%
97/219 • Number of events 578 • 6.75 years
|
34.3%
36/105 • Number of events 278 • 6.75 years
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
5.6%
13/232 • Number of events 37 • 6.75 years
|
2.1%
5/233 • Number of events 12 • 6.75 years
|
5.0%
11/219 • Number of events 55 • 6.75 years
|
4.8%
5/105 • Number of events 9 • 6.75 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.8%
25/232 • Number of events 61 • 6.75 years
|
12.9%
30/233 • Number of events 66 • 6.75 years
|
11.9%
26/219 • Number of events 78 • 6.75 years
|
10.5%
11/105 • Number of events 51 • 6.75 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
3.0%
7/232 • Number of events 16 • 6.75 years
|
1.7%
4/233 • Number of events 7 • 6.75 years
|
0.91%
2/219 • Number of events 14 • 6.75 years
|
1.9%
2/105 • Number of events 2 • 6.75 years
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
0.00%
0/232 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.46%
1/219 • Number of events 1 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.86%
2/232 • Number of events 2 • 6.75 years
|
0.43%
1/233 • Number of events 1 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.95%
1/105 • Number of events 1 • 6.75 years
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
1.3%
3/232 • Number of events 6 • 6.75 years
|
0.86%
2/233 • Number of events 3 • 6.75 years
|
0.91%
2/219 • Number of events 5 • 6.75 years
|
0.95%
1/105 • Number of events 2 • 6.75 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
6.5%
15/232 • Number of events 28 • 6.75 years
|
7.7%
18/233 • Number of events 28 • 6.75 years
|
6.4%
14/219 • Number of events 33 • 6.75 years
|
1.9%
2/105 • Number of events 5 • 6.75 years
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.86%
2/232 • Number of events 3 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
1.8%
4/219 • Number of events 5 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
16.8%
39/232 • Number of events 93 • 6.75 years
|
8.6%
20/233 • Number of events 48 • 6.75 years
|
10.5%
23/219 • Number of events 72 • 6.75 years
|
1.9%
2/105 • Number of events 9 • 6.75 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
2.2%
5/232 • Number of events 6 • 6.75 years
|
1.3%
3/233 • Number of events 7 • 6.75 years
|
1.4%
3/219 • Number of events 5 • 6.75 years
|
0.95%
1/105 • Number of events 9 • 6.75 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
0.00%
0/232 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.46%
1/219 • Number of events 2 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal, conn tissue - Oth spec
|
7.8%
18/232 • Number of events 54 • 6.75 years
|
4.7%
11/233 • Number of events 33 • 6.75 years
|
8.2%
18/219 • Number of events 47 • 6.75 years
|
7.6%
8/105 • Number of events 58 • 6.75 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.7%
11/232 • Number of events 17 • 6.75 years
|
9.0%
21/233 • Number of events 50 • 6.75 years
|
3.7%
8/219 • Number of events 20 • 6.75 years
|
6.7%
7/105 • Number of events 19 • 6.75 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.2%
5/232 • Number of events 7 • 6.75 years
|
1.3%
3/233 • Number of events 10 • 6.75 years
|
3.2%
7/219 • Number of events 15 • 6.75 years
|
1.9%
2/105 • Number of events 4 • 6.75 years
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.43%
1/232 • Number of events 2 • 6.75 years
|
0.43%
1/233 • Number of events 2 • 6.75 years
|
0.91%
2/219 • Number of events 6 • 6.75 years
|
2.9%
3/105 • Number of events 11 • 6.75 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.9%
23/232 • Number of events 44 • 6.75 years
|
4.7%
11/233 • Number of events 16 • 6.75 years
|
13.2%
29/219 • Number of events 109 • 6.75 years
|
3.8%
4/105 • Number of events 10 • 6.75 years
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/232 • 6.75 years
|
0.86%
2/233 • Number of events 2 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff injury
|
0.00%
0/232 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.46%
1/219 • Number of events 6 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
0.00%
0/232 • 6.75 years
|
0.43%
1/233 • Number of events 2 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/232 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.95%
1/105 • Number of events 1 • 6.75 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, mal, uncpec - Oth spec
|
8.2%
19/232 • Number of events 27 • 6.75 years
|
7.3%
17/233 • Number of events 35 • 6.75 years
|
13.2%
29/219 • Number of events 63 • 6.75 years
|
12.4%
13/105 • Number of events 36 • 6.75 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/232 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.91%
2/219 • Number of events 8 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Treatment related secondary malignancy
|
0.43%
1/232 • Number of events 1 • 6.75 years
|
0.43%
1/233 • Number of events 1 • 6.75 years
|
0.91%
2/219 • Number of events 2 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Nervous system disorders
Amnesia
|
0.86%
2/232 • Number of events 2 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.91%
2/219 • Number of events 3 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Nervous system disorders
Anosmia
|
0.00%
0/232 • 6.75 years
|
0.43%
1/233 • Number of events 7 • 6.75 years
|
0.46%
1/219 • Number of events 4 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Nervous system disorders
Ataxia
|
0.00%
0/232 • 6.75 years
|
0.43%
1/233 • Number of events 1 • 6.75 years
|
0.46%
1/219 • Number of events 1 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Nervous system disorders
Cognitive disturbance
|
0.86%
2/232 • Number of events 3 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
1.4%
3/219 • Number of events 12 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Nervous system disorders
Concentration impairment
|
0.00%
0/232 • 6.75 years
|
1.3%
3/233 • Number of events 7 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.95%
1/105 • Number of events 1 • 6.75 years
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/232 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.46%
1/219 • Number of events 1 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Nervous system disorders
Dizziness
|
12.9%
30/232 • Number of events 60 • 6.75 years
|
15.0%
35/233 • Number of events 67 • 6.75 years
|
6.8%
15/219 • Number of events 38 • 6.75 years
|
6.7%
7/105 • Number of events 10 • 6.75 years
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/232 • 6.75 years
|
0.43%
1/233 • Number of events 1 • 6.75 years
|
0.46%
1/219 • Number of events 1 • 6.75 years
|
0.95%
1/105 • Number of events 3 • 6.75 years
|
|
Nervous system disorders
Dysesthesia
|
0.43%
1/232 • Number of events 2 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Nervous system disorders
Dysgeusia
|
2.6%
6/232 • Number of events 21 • 6.75 years
|
7.7%
18/233 • Number of events 47 • 6.75 years
|
2.3%
5/219 • Number of events 11 • 6.75 years
|
3.8%
4/105 • Number of events 6 • 6.75 years
|
|
Nervous system disorders
Encephalopathy
|
0.43%
1/232 • Number of events 1 • 6.75 years
|
0.43%
1/233 • Number of events 1 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
1.9%
2/105 • Number of events 2 • 6.75 years
|
|
Nervous system disorders
Extrapyramidal disorder
|
0.00%
0/232 • 6.75 years
|
0.86%
2/233 • Number of events 4 • 6.75 years
|
1.4%
3/219 • Number of events 6 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Nervous system disorders
Headache
|
12.9%
30/232 • Number of events 81 • 6.75 years
|
14.2%
33/233 • Number of events 74 • 6.75 years
|
7.3%
16/219 • Number of events 48 • 6.75 years
|
4.8%
5/105 • Number of events 15 • 6.75 years
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/232 • 6.75 years
|
0.43%
1/233 • Number of events 1 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.86%
2/232 • Number of events 2 • 6.75 years
|
0.43%
1/233 • Number of events 4 • 6.75 years
|
1.4%
3/219 • Number of events 3 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Nervous system disorders
Lethargy
|
1.3%
3/232 • Number of events 3 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.46%
1/219 • Number of events 1 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Nervous system disorders
Memory impairment
|
0.43%
1/232 • Number of events 1 • 6.75 years
|
2.1%
5/233 • Number of events 15 • 6.75 years
|
0.91%
2/219 • Number of events 24 • 6.75 years
|
2.9%
3/105 • Number of events 7 • 6.75 years
|
|
Nervous system disorders
Muscle weakness left-sided
|
0.43%
1/232 • Number of events 1 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Nervous system disorders
Nervous system disorders - Oth spec
|
1.3%
3/232 • Number of events 4 • 6.75 years
|
1.7%
4/233 • Number of events 4 • 6.75 years
|
2.7%
6/219 • Number of events 11 • 6.75 years
|
1.9%
2/105 • Number of events 3 • 6.75 years
|
|
Nervous system disorders
Neuralgia
|
0.43%
1/232 • Number of events 4 • 6.75 years
|
0.86%
2/233 • Number of events 4 • 6.75 years
|
0.46%
1/219 • Number of events 1 • 6.75 years
|
0.95%
1/105 • Number of events 5 • 6.75 years
|
|
Nervous system disorders
Paresthesia
|
2.6%
6/232 • Number of events 8 • 6.75 years
|
5.2%
12/233 • Number of events 28 • 6.75 years
|
1.4%
3/219 • Number of events 11 • 6.75 years
|
3.8%
4/105 • Number of events 16 • 6.75 years
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.43%
1/232 • Number of events 1 • 6.75 years
|
0.43%
1/233 • Number of events 6 • 6.75 years
|
1.4%
3/219 • Number of events 15 • 6.75 years
|
0.95%
1/105 • Number of events 8 • 6.75 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
6.5%
15/232 • Number of events 49 • 6.75 years
|
6.9%
16/233 • Number of events 34 • 6.75 years
|
9.6%
21/219 • Number of events 101 • 6.75 years
|
3.8%
4/105 • Number of events 12 • 6.75 years
|
|
Nervous system disorders
Presyncope
|
0.43%
1/232 • Number of events 1 • 6.75 years
|
0.86%
2/233 • Number of events 4 • 6.75 years
|
1.4%
3/219 • Number of events 3 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Nervous system disorders
Reversbl posterior leukoenceph syndrome
|
0.00%
0/232 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.46%
1/219 • Number of events 1 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Nervous system disorders
Seizure
|
0.00%
0/232 • 6.75 years
|
0.86%
2/233 • Number of events 2 • 6.75 years
|
0.91%
2/219 • Number of events 2 • 6.75 years
|
0.95%
1/105 • Number of events 3 • 6.75 years
|
|
Nervous system disorders
Somnolence
|
1.7%
4/232 • Number of events 10 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.46%
1/219 • Number of events 1 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Nervous system disorders
Spasticity
|
0.00%
0/232 • 6.75 years
|
0.43%
1/233 • Number of events 1 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/232 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.95%
1/105 • Number of events 1 • 6.75 years
|
|
Nervous system disorders
Stroke
|
0.86%
2/232 • Number of events 2 • 6.75 years
|
0.43%
1/233 • Number of events 1 • 6.75 years
|
0.46%
1/219 • Number of events 1 • 6.75 years
|
0.95%
1/105 • Number of events 1 • 6.75 years
|
|
Nervous system disorders
Syncope
|
1.7%
4/232 • Number of events 4 • 6.75 years
|
5.2%
12/233 • Number of events 14 • 6.75 years
|
1.8%
4/219 • Number of events 4 • 6.75 years
|
2.9%
3/105 • Number of events 3 • 6.75 years
|
|
Nervous system disorders
Transient ischemic attacks
|
1.3%
3/232 • Number of events 3 • 6.75 years
|
0.43%
1/233 • Number of events 1 • 6.75 years
|
0.46%
1/219 • Number of events 1 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Nervous system disorders
Tremor
|
2.6%
6/232 • Number of events 26 • 6.75 years
|
1.7%
4/233 • Number of events 13 • 6.75 years
|
3.2%
7/219 • Number of events 45 • 6.75 years
|
0.95%
1/105 • Number of events 17 • 6.75 years
|
|
Nervous system disorders
Vasovagal reaction
|
0.00%
0/232 • 6.75 years
|
0.43%
1/233 • Number of events 1 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Psychiatric disorders
Agitation
|
0.43%
1/232 • Number of events 1 • 6.75 years
|
1.3%
3/233 • Number of events 3 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Psychiatric disorders
Anxiety
|
4.3%
10/232 • Number of events 41 • 6.75 years
|
5.6%
13/233 • Number of events 28 • 6.75 years
|
5.9%
13/219 • Number of events 90 • 6.75 years
|
3.8%
4/105 • Number of events 16 • 6.75 years
|
|
Psychiatric disorders
Confusion
|
2.6%
6/232 • Number of events 6 • 6.75 years
|
2.6%
6/233 • Number of events 8 • 6.75 years
|
2.7%
6/219 • Number of events 6 • 6.75 years
|
0.95%
1/105 • Number of events 2 • 6.75 years
|
|
Psychiatric disorders
Delayed orgasm
|
0.43%
1/232 • Number of events 1 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Psychiatric disorders
Delirium
|
0.43%
1/232 • Number of events 1 • 6.75 years
|
0.43%
1/233 • Number of events 1 • 6.75 years
|
0.91%
2/219 • Number of events 2 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Psychiatric disorders
Depression
|
4.3%
10/232 • Number of events 21 • 6.75 years
|
0.86%
2/233 • Number of events 4 • 6.75 years
|
5.9%
13/219 • Number of events 60 • 6.75 years
|
1.9%
2/105 • Number of events 14 • 6.75 years
|
|
Psychiatric disorders
Hallucinations
|
0.00%
0/232 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.46%
1/219 • Number of events 1 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Psychiatric disorders
Insomnia
|
10.8%
25/232 • Number of events 47 • 6.75 years
|
7.7%
18/233 • Number of events 35 • 6.75 years
|
5.0%
11/219 • Number of events 38 • 6.75 years
|
6.7%
7/105 • Number of events 41 • 6.75 years
|
|
Psychiatric disorders
Irritability
|
0.00%
0/232 • 6.75 years
|
0.43%
1/233 • Number of events 1 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
0.43%
1/232 • Number of events 3 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.46%
1/219 • Number of events 1 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Psychiatric disorders
Suicide attempt
|
0.43%
1/232 • Number of events 2 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Renal and urinary disorders
Acute kidney injury
|
1.3%
3/232 • Number of events 4 • 6.75 years
|
2.1%
5/233 • Number of events 6 • 6.75 years
|
5.9%
13/219 • Number of events 14 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Renal and urinary disorders
Bladder spasm
|
0.00%
0/232 • 6.75 years
|
0.43%
1/233 • Number of events 3 • 6.75 years
|
0.46%
1/219 • Number of events 1 • 6.75 years
|
0.95%
1/105 • Number of events 3 • 6.75 years
|
|
Renal and urinary disorders
Chronic kidney disease
|
3.9%
9/232 • Number of events 22 • 6.75 years
|
3.4%
8/233 • Number of events 26 • 6.75 years
|
10.0%
22/219 • Number of events 92 • 6.75 years
|
7.6%
8/105 • Number of events 45 • 6.75 years
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.00%
0/232 • 6.75 years
|
0.43%
1/233 • Number of events 2 • 6.75 years
|
1.4%
3/219 • Number of events 7 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Renal and urinary disorders
Dysuria (painful urination)
|
0.43%
1/232 • Number of events 3 • 6.75 years
|
0.86%
2/233 • Number of events 6 • 6.75 years
|
2.7%
6/219 • Number of events 10 • 6.75 years
|
0.95%
1/105 • Number of events 1 • 6.75 years
|
|
Renal and urinary disorders
Glucosuria
|
0.86%
2/232 • Number of events 3 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Renal and urinary disorders
Hematuria
|
6.0%
14/232 • Number of events 22 • 6.75 years
|
3.9%
9/233 • Number of events 18 • 6.75 years
|
7.3%
16/219 • Number of events 34 • 6.75 years
|
6.7%
7/105 • Number of events 8 • 6.75 years
|
|
Renal and urinary disorders
Proteinuria
|
0.86%
2/232 • Number of events 2 • 6.75 years
|
1.7%
4/233 • Number of events 5 • 6.75 years
|
1.8%
4/219 • Number of events 4 • 6.75 years
|
0.95%
1/105 • Number of events 1 • 6.75 years
|
|
Renal and urinary disorders
Renal and urinary disorders - Oth spec
|
3.0%
7/232 • Number of events 14 • 6.75 years
|
0.86%
2/233 • Number of events 2 • 6.75 years
|
3.7%
8/219 • Number of events 10 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Renal and urinary disorders
Renal calculi
|
0.86%
2/232 • Number of events 2 • 6.75 years
|
1.3%
3/233 • Number of events 3 • 6.75 years
|
0.91%
2/219 • Number of events 4 • 6.75 years
|
0.95%
1/105 • Number of events 1 • 6.75 years
|
|
Renal and urinary disorders
Urinary frequency
|
2.6%
6/232 • Number of events 15 • 6.75 years
|
3.4%
8/233 • Number of events 12 • 6.75 years
|
4.1%
9/219 • Number of events 20 • 6.75 years
|
2.9%
3/105 • Number of events 7 • 6.75 years
|
|
Renal and urinary disorders
Urinary incontinence
|
1.7%
4/232 • Number of events 5 • 6.75 years
|
0.43%
1/233 • Number of events 1 • 6.75 years
|
0.91%
2/219 • Number of events 7 • 6.75 years
|
2.9%
3/105 • Number of events 5 • 6.75 years
|
|
Renal and urinary disorders
Urinary retention
|
1.3%
3/232 • Number of events 4 • 6.75 years
|
0.86%
2/233 • Number of events 4 • 6.75 years
|
2.7%
6/219 • Number of events 28 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/232 • 6.75 years
|
0.43%
1/233 • Number of events 1 • 6.75 years
|
0.46%
1/219 • Number of events 1 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/232 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.46%
1/219 • Number of events 2 • 6.75 years
|
0.95%
1/105 • Number of events 1 • 6.75 years
|
|
Renal and urinary disorders
Urinary urgency
|
0.43%
1/232 • Number of events 4 • 6.75 years
|
1.7%
4/233 • Number of events 6 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
1.9%
2/105 • Number of events 2 • 6.75 years
|
|
Renal and urinary disorders
Urine discoloration
|
0.00%
0/232 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.46%
1/219 • Number of events 1 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Reproductive system and breast disorders
Breast pain
|
0.43%
1/232 • Number of events 2 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.46%
1/219 • Number of events 1 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/232 • 6.75 years
|
0.86%
2/233 • Number of events 8 • 6.75 years
|
0.46%
1/219 • Number of events 1 • 6.75 years
|
2.9%
3/105 • Number of events 29 • 6.75 years
|
|
Reproductive system and breast disorders
Genital edema
|
0.00%
0/232 • 6.75 years
|
0.43%
1/233 • Number of events 1 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.86%
2/232 • Number of events 2 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Reproductive system and breast disorders
Prostatic obstruction
|
0.00%
0/232 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.95%
1/105 • Number of events 1 • 6.75 years
|
|
Reproductive system and breast disorders
Reproductive system and breast -Oth spec
|
0.43%
1/232 • Number of events 1 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
1.4%
3/219 • Number of events 5 • 6.75 years
|
2.9%
3/105 • Number of events 25 • 6.75 years
|
|
Reproductive system and breast disorders
Testicular pain
|
0.43%
1/232 • Number of events 1 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.95%
1/105 • Number of events 1 • 6.75 years
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
0.00%
0/232 • 6.75 years
|
0.43%
1/233 • Number of events 3 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Reproductive system and breast disorders
Vaginal inflammation
|
0.43%
1/232 • Number of events 1 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
0.00%
0/232 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.46%
1/219 • Number of events 1 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
1.7%
4/232 • Number of events 10 • 6.75 years
|
1.7%
4/233 • Number of events 13 • 6.75 years
|
1.8%
4/219 • Number of events 12 • 6.75 years
|
2.9%
3/105 • Number of events 11 • 6.75 years
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/232 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.46%
1/219 • Number of events 3 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/232 • 6.75 years
|
0.43%
1/233 • Number of events 1 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Respiratory, thoracic and mediastinal disorders
Chylothorax
|
0.43%
1/232 • Number of events 2 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.46%
1/219 • Number of events 2 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.9%
23/232 • Number of events 51 • 6.75 years
|
17.6%
41/233 • Number of events 90 • 6.75 years
|
19.2%
42/219 • Number of events 95 • 6.75 years
|
14.3%
15/105 • Number of events 54 • 6.75 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
17.2%
40/232 • Number of events 83 • 6.75 years
|
18.0%
42/233 • Number of events 82 • 6.75 years
|
14.6%
32/219 • Number of events 85 • 6.75 years
|
9.5%
10/105 • Number of events 21 • 6.75 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.2%
12/232 • Number of events 17 • 6.75 years
|
6.0%
14/233 • Number of events 25 • 6.75 years
|
4.6%
10/219 • Number of events 17 • 6.75 years
|
1.9%
2/105 • Number of events 4 • 6.75 years
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/232 • 6.75 years
|
1.3%
3/233 • Number of events 5 • 6.75 years
|
0.46%
1/219 • Number of events 3 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.43%
1/232 • Number of events 1 • 6.75 years
|
1.7%
4/233 • Number of events 8 • 6.75 years
|
0.91%
2/219 • Number of events 2 • 6.75 years
|
0.95%
1/105 • Number of events 1 • 6.75 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.9%
9/232 • Number of events 12 • 6.75 years
|
4.3%
10/233 • Number of events 14 • 6.75 years
|
5.5%
12/219 • Number of events 13 • 6.75 years
|
0.95%
1/105 • Number of events 1 • 6.75 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
3.9%
9/232 • Number of events 15 • 6.75 years
|
4.3%
10/233 • Number of events 15 • 6.75 years
|
6.4%
14/219 • Number of events 29 • 6.75 years
|
6.7%
7/105 • Number of events 11 • 6.75 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.6%
6/232 • Number of events 14 • 6.75 years
|
2.1%
5/233 • Number of events 12 • 6.75 years
|
3.7%
8/219 • Number of events 12 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural hemorrhage
|
0.43%
1/232 • Number of events 1 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/232 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.46%
1/219 • Number of events 3 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.9%
9/232 • Number of events 10 • 6.75 years
|
1.3%
3/233 • Number of events 3 • 6.75 years
|
1.4%
3/219 • Number of events 5 • 6.75 years
|
0.95%
1/105 • Number of events 1 • 6.75 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/232 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
1.9%
2/105 • Number of events 2 • 6.75 years
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
1.7%
4/232 • Number of events 5 • 6.75 years
|
1.3%
3/233 • Number of events 4 • 6.75 years
|
3.7%
8/219 • Number of events 9 • 6.75 years
|
1.9%
2/105 • Number of events 3 • 6.75 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
1.3%
3/232 • Number of events 6 • 6.75 years
|
2.1%
5/233 • Number of events 7 • 6.75 years
|
3.7%
8/219 • Number of events 22 • 6.75 years
|
2.9%
3/105 • Number of events 5 • 6.75 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.43%
1/232 • Number of events 1 • 6.75 years
|
1.7%
4/233 • Number of events 4 • 6.75 years
|
1.8%
4/219 • Number of events 4 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/232 • 6.75 years
|
0.43%
1/233 • Number of events 1 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.43%
1/232 • Number of events 9 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.46%
1/219 • Number of events 6 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic, mediastinal - Oth spec
|
2.6%
6/232 • Number of events 7 • 6.75 years
|
5.6%
13/233 • Number of events 16 • 6.75 years
|
4.6%
10/219 • Number of events 34 • 6.75 years
|
6.7%
7/105 • Number of events 21 • 6.75 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.3%
3/232 • Number of events 3 • 6.75 years
|
2.6%
6/233 • Number of events 6 • 6.75 years
|
4.1%
9/219 • Number of events 9 • 6.75 years
|
0.95%
1/105 • Number of events 1 • 6.75 years
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
1.3%
3/232 • Number of events 8 • 6.75 years
|
1.3%
3/233 • Number of events 3 • 6.75 years
|
4.6%
10/219 • Number of events 30 • 6.75 years
|
0.95%
1/105 • Number of events 1 • 6.75 years
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
0.00%
0/232 • 6.75 years
|
0.43%
1/233 • Number of events 2 • 6.75 years
|
0.46%
1/219 • Number of events 1 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
0.00%
0/232 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.91%
2/219 • Number of events 4 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
0.43%
1/232 • Number of events 2 • 6.75 years
|
1.3%
3/233 • Number of events 10 • 6.75 years
|
1.8%
4/219 • Number of events 27 • 6.75 years
|
4.8%
5/105 • Number of events 24 • 6.75 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
2.6%
6/232 • Number of events 9 • 6.75 years
|
4.3%
10/233 • Number of events 11 • 6.75 years
|
1.4%
3/219 • Number of events 8 • 6.75 years
|
2.9%
3/105 • Number of events 4 • 6.75 years
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
0.43%
1/232 • Number of events 1 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.43%
1/232 • Number of events 8 • 6.75 years
|
0.86%
2/233 • Number of events 2 • 6.75 years
|
0.46%
1/219 • Number of events 14 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.4%
8/232 • Number of events 32 • 6.75 years
|
2.1%
5/233 • Number of events 16 • 6.75 years
|
1.8%
4/219 • Number of events 11 • 6.75 years
|
1.9%
2/105 • Number of events 2 • 6.75 years
|
|
Skin and subcutaneous tissue disorders
Bullous dermatitis
|
0.00%
0/232 • 6.75 years
|
1.7%
4/233 • Number of events 4 • 6.75 years
|
0.46%
1/219 • Number of events 1 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.2%
19/232 • Number of events 46 • 6.75 years
|
6.9%
16/233 • Number of events 43 • 6.75 years
|
7.8%
17/219 • Number of events 105 • 6.75 years
|
4.8%
5/105 • Number of events 42 • 6.75 years
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/232 • 6.75 years
|
1.3%
3/233 • Number of events 12 • 6.75 years
|
3.2%
7/219 • Number of events 29 • 6.75 years
|
1.9%
2/105 • Number of events 6 • 6.75 years
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.43%
1/232 • Number of events 1 • 6.75 years
|
0.43%
1/233 • Number of events 1 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Skin and subcutaneous tissue disorders
Hair texture abnormal
|
0.00%
0/232 • 6.75 years
|
0.43%
1/233 • Number of events 1 • 6.75 years
|
0.46%
1/219 • Number of events 5 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
3.4%
8/232 • Number of events 20 • 6.75 years
|
4.7%
11/233 • Number of events 13 • 6.75 years
|
1.8%
4/219 • Number of events 4 • 6.75 years
|
0.95%
1/105 • Number of events 1 • 6.75 years
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
1.3%
3/232 • Number of events 3 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.91%
2/219 • Number of events 4 • 6.75 years
|
1.9%
2/105 • Number of events 3 • 6.75 years
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
3.9%
9/232 • Number of events 26 • 6.75 years
|
2.6%
6/233 • Number of events 23 • 6.75 years
|
9.6%
21/219 • Number of events 99 • 6.75 years
|
3.8%
4/105 • Number of events 23 • 6.75 years
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
0.43%
1/232 • Number of events 3 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
0.86%
2/232 • Number of events 3 • 6.75 years
|
0.43%
1/233 • Number of events 1 • 6.75 years
|
1.4%
3/219 • Number of events 5 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
0.43%
1/232 • Number of events 1 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.46%
1/219 • Number of events 1 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrm
|
0.00%
0/232 • 6.75 years
|
0.43%
1/233 • Number of events 1 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
0.00%
0/232 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.46%
1/219 • Number of events 1 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.5%
15/232 • Number of events 35 • 6.75 years
|
8.2%
19/233 • Number of events 32 • 6.75 years
|
4.1%
9/219 • Number of events 27 • 6.75 years
|
0.95%
1/105 • Number of events 6 • 6.75 years
|
|
Skin and subcutaneous tissue disorders
Purpura
|
1.7%
4/232 • Number of events 4 • 6.75 years
|
1.7%
4/233 • Number of events 7 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
2.2%
5/232 • Number of events 17 • 6.75 years
|
2.1%
5/233 • Number of events 7 • 6.75 years
|
0.46%
1/219 • Number of events 6 • 6.75 years
|
3.8%
4/105 • Number of events 6 • 6.75 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
28.0%
65/232 • Number of events 159 • 6.75 years
|
30.0%
70/233 • Number of events 157 • 6.75 years
|
20.1%
44/219 • Number of events 142 • 6.75 years
|
18.1%
19/105 • Number of events 54 • 6.75 years
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
0.00%
0/232 • 6.75 years
|
0.43%
1/233 • Number of events 4 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Gastrointestinal disorders
Dry mouth
|
1.3%
3/232 • Number of events 4 • 6.75 years
|
4.7%
11/233 • Number of events 27 • 6.75 years
|
3.2%
7/219 • Number of events 15 • 6.75 years
|
2.9%
3/105 • Number of events 19 • 6.75 years
|
|
Gastrointestinal disorders
Dyspepsia
|
3.0%
7/232 • Number of events 23 • 6.75 years
|
8.6%
20/233 • Number of events 55 • 6.75 years
|
5.0%
11/219 • Number of events 25 • 6.75 years
|
1.9%
2/105 • Number of events 2 • 6.75 years
|
|
Gastrointestinal disorders
Dysphagia
|
1.3%
3/232 • Number of events 4 • 6.75 years
|
2.6%
6/233 • Number of events 6 • 6.75 years
|
2.7%
6/219 • Number of events 12 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/232 • 6.75 years
|
0.43%
1/233 • Number of events 1 • 6.75 years
|
0.46%
1/219 • Number of events 1 • 6.75 years
|
0.95%
1/105 • Number of events 1 • 6.75 years
|
|
Gastrointestinal disorders
Esophagitis
|
0.43%
1/232 • Number of events 1 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
1.4%
3/219 • Number of events 6 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Gastrointestinal disorders
Fecal incontinence
|
1.3%
3/232 • Number of events 3 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.46%
1/219 • Number of events 2 • 6.75 years
|
0.95%
1/105 • Number of events 2 • 6.75 years
|
|
Gastrointestinal disorders
Flatulence
|
0.43%
1/232 • Number of events 6 • 6.75 years
|
4.3%
10/233 • Number of events 16 • 6.75 years
|
1.4%
3/219 • Number of events 8 • 6.75 years
|
1.9%
2/105 • Number of events 16 • 6.75 years
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
0.86%
2/232 • Number of events 3 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.46%
1/219 • Number of events 1 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/232 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.46%
1/219 • Number of events 1 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/232 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.91%
2/219 • Number of events 17 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
6.0%
14/232 • Number of events 48 • 6.75 years
|
4.3%
10/233 • Number of events 41 • 6.75 years
|
5.5%
12/219 • Number of events 45 • 6.75 years
|
4.8%
5/105 • Number of events 22 • 6.75 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Oth spec
|
3.4%
8/232 • Number of events 17 • 6.75 years
|
7.3%
17/233 • Number of events 28 • 6.75 years
|
5.5%
12/219 • Number of events 33 • 6.75 years
|
3.8%
4/105 • Number of events 17 • 6.75 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcut tissue disord - Oth spec
|
14.2%
33/232 • Number of events 68 • 6.75 years
|
8.6%
20/233 • Number of events 40 • 6.75 years
|
16.4%
36/219 • Number of events 115 • 6.75 years
|
8.6%
9/105 • Number of events 52 • 6.75 years
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.86%
2/232 • Number of events 3 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.46%
1/219 • Number of events 1 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
0.43%
1/232 • Number of events 1 • 6.75 years
|
0.43%
1/233 • Number of events 1 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.86%
2/232 • Number of events 3 • 6.75 years
|
0.86%
2/233 • Number of events 2 • 6.75 years
|
2.3%
5/219 • Number of events 6 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Surgical and medical procedures
Surgical and medical proced - Oth spec
|
2.2%
5/232 • Number of events 8 • 6.75 years
|
1.7%
4/233 • Number of events 6 • 6.75 years
|
4.1%
9/219 • Number of events 11 • 6.75 years
|
2.9%
3/105 • Number of events 4 • 6.75 years
|
|
Vascular disorders
Capillary leak syndrome
|
0.43%
1/232 • Number of events 1 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Vascular disorders
Flushing
|
0.86%
2/232 • Number of events 3 • 6.75 years
|
2.1%
5/233 • Number of events 5 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.95%
1/105 • Number of events 1 • 6.75 years
|
|
Vascular disorders
Hematoma
|
2.6%
6/232 • Number of events 7 • 6.75 years
|
1.3%
3/233 • Number of events 3 • 6.75 years
|
1.4%
3/219 • Number of events 3 • 6.75 years
|
0.95%
1/105 • Number of events 3 • 6.75 years
|
|
Vascular disorders
Hot flashes
|
1.7%
4/232 • Number of events 7 • 6.75 years
|
0.86%
2/233 • Number of events 5 • 6.75 years
|
2.7%
6/219 • Number of events 14 • 6.75 years
|
2.9%
3/105 • Number of events 9 • 6.75 years
|
|
Vascular disorders
Hypertension
|
67.2%
156/232 • Number of events 900 • 6.75 years
|
73.4%
171/233 • Number of events 947 • 6.75 years
|
72.1%
158/219 • Number of events 1368 • 6.75 years
|
77.1%
81/105 • Number of events 644 • 6.75 years
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
1.3%
3/232 • Number of events 3 • 6.75 years
|
1.3%
3/233 • Number of events 3 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Gastrointestinal disorders
Gastroparesis
|
0.00%
0/232 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.46%
1/219 • Number of events 1 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/232 • 6.75 years
|
0.43%
1/233 • Number of events 2 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
0.00%
0/232 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.46%
1/219 • Number of events 1 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Gastrointestinal disorders
Hemorrhoids
|
1.7%
4/232 • Number of events 10 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
1.8%
4/219 • Number of events 5 • 6.75 years
|
0.95%
1/105 • Number of events 15 • 6.75 years
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/232 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.46%
1/219 • Number of events 1 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
0.00%
0/232 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.46%
1/219 • Number of events 1 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Gastrointestinal disorders
Mucositis oral
|
8.6%
20/232 • Number of events 42 • 6.75 years
|
10.7%
25/233 • Number of events 50 • 6.75 years
|
5.9%
13/219 • Number of events 49 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Gastrointestinal disorders
Nausea
|
17.7%
41/232 • Number of events 83 • 6.75 years
|
27.9%
65/233 • Number of events 165 • 6.75 years
|
8.7%
19/219 • Number of events 35 • 6.75 years
|
7.6%
8/105 • Number of events 38 • 6.75 years
|
|
Gastrointestinal disorders
Oral dysesthesia
|
0.43%
1/232 • Number of events 3 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Gastrointestinal disorders
Oral hemorrhage
|
0.43%
1/232 • Number of events 1 • 6.75 years
|
1.3%
3/233 • Number of events 7 • 6.75 years
|
1.4%
3/219 • Number of events 3 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Gastrointestinal disorders
Oral pain
|
2.6%
6/232 • Number of events 9 • 6.75 years
|
1.7%
4/233 • Number of events 7 • 6.75 years
|
1.8%
4/219 • Number of events 17 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/232 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.95%
1/105 • Number of events 2 • 6.75 years
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.43%
1/232 • Number of events 1 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.46%
1/219 • Number of events 1 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Gastrointestinal disorders
Rectal pain
|
0.00%
0/232 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.46%
1/219 • Number of events 1 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Gastrointestinal disorders
Retroperitoneal hemorrhage
|
0.00%
0/232 • 6.75 years
|
0.43%
1/233 • Number of events 1 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.43%
1/232 • Number of events 1 • 6.75 years
|
1.3%
3/233 • Number of events 3 • 6.75 years
|
0.46%
1/219 • Number of events 2 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/232 • 6.75 years
|
0.86%
2/233 • Number of events 2 • 6.75 years
|
0.46%
1/219 • Number of events 3 • 6.75 years
|
1.9%
2/105 • Number of events 10 • 6.75 years
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/232 • 6.75 years
|
0.86%
2/233 • Number of events 2 • 6.75 years
|
0.46%
1/219 • Number of events 1 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.43%
1/232 • Number of events 1 • 6.75 years
|
0.43%
1/233 • Number of events 1 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Gastrointestinal disorders
Vomiting
|
5.6%
13/232 • Number of events 15 • 6.75 years
|
12.4%
29/233 • Number of events 49 • 6.75 years
|
6.4%
14/219 • Number of events 19 • 6.75 years
|
2.9%
3/105 • Number of events 3 • 6.75 years
|
|
Vascular disorders
Hypotension
|
4.7%
11/232 • Number of events 11 • 6.75 years
|
7.3%
17/233 • Number of events 17 • 6.75 years
|
4.1%
9/219 • Number of events 12 • 6.75 years
|
2.9%
3/105 • Number of events 4 • 6.75 years
|
|
Vascular disorders
Lymphedema
|
0.00%
0/232 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
1.4%
3/219 • Number of events 5 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Vascular disorders
Peripheral ischemia
|
0.00%
0/232 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.46%
1/219 • Number of events 1 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Vascular disorders
Superficial thrombophlebitis
|
0.00%
0/232 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.46%
1/219 • Number of events 1 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Vascular disorders
Thromboembolic event
|
0.86%
2/232 • Number of events 2 • 6.75 years
|
1.3%
3/233 • Number of events 4 • 6.75 years
|
2.7%
6/219 • Number of events 14 • 6.75 years
|
0.95%
1/105 • Number of events 1 • 6.75 years
|
|
Vascular disorders
Vascular disorders - Other, specify
|
0.86%
2/232 • Number of events 7 • 6.75 years
|
0.43%
1/233 • Number of events 6 • 6.75 years
|
0.91%
2/219 • Number of events 2 • 6.75 years
|
0.95%
1/105 • Number of events 13 • 6.75 years
|
|
Vascular disorders
Vasculitis
|
0.00%
0/232 • 6.75 years
|
0.43%
1/233 • Number of events 1 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.95%
1/105 • Number of events 1 • 6.75 years
|
|
General disorders
Chills
|
8.2%
19/232 • Number of events 23 • 6.75 years
|
10.3%
24/233 • Number of events 33 • 6.75 years
|
1.8%
4/219 • Number of events 5 • 6.75 years
|
0.95%
1/105 • Number of events 1 • 6.75 years
|
|
General disorders
Death NOS
|
0.00%
0/232 • 6.75 years
|
1.7%
4/233 • Number of events 4 • 6.75 years
|
1.4%
3/219 • Number of events 3 • 6.75 years
|
0.95%
1/105 • Number of events 1 • 6.75 years
|
|
General disorders
Edema face
|
0.00%
0/232 • 6.75 years
|
0.43%
1/233 • Number of events 1 • 6.75 years
|
0.46%
1/219 • Number of events 1 • 6.75 years
|
0.95%
1/105 • Number of events 1 • 6.75 years
|
|
General disorders
Edema limbs
|
37.5%
87/232 • Number of events 329 • 6.75 years
|
35.2%
82/233 • Number of events 331 • 6.75 years
|
46.6%
102/219 • Number of events 644 • 6.75 years
|
21.0%
22/105 • Number of events 91 • 6.75 years
|
|
General disorders
Facial pain
|
0.00%
0/232 • 6.75 years
|
0.43%
1/233 • Number of events 1 • 6.75 years
|
0.46%
1/219 • Number of events 1 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
General disorders
Fatigue
|
75.4%
175/232 • Number of events 933 • 6.75 years
|
79.4%
185/233 • Number of events 1004 • 6.75 years
|
71.7%
157/219 • Number of events 1162 • 6.75 years
|
70.5%
74/105 • Number of events 386 • 6.75 years
|
|
General disorders
Fever
|
8.6%
20/232 • Number of events 21 • 6.75 years
|
9.9%
23/233 • Number of events 24 • 6.75 years
|
5.9%
13/219 • Number of events 13 • 6.75 years
|
1.9%
2/105 • Number of events 2 • 6.75 years
|
|
General disorders
Flu like symptoms
|
3.0%
7/232 • Number of events 10 • 6.75 years
|
2.1%
5/233 • Number of events 6 • 6.75 years
|
1.8%
4/219 • Number of events 4 • 6.75 years
|
1.9%
2/105 • Number of events 2 • 6.75 years
|
|
General disorders
Gait disturbance
|
2.2%
5/232 • Number of events 9 • 6.75 years
|
0.43%
1/233 • Number of events 4 • 6.75 years
|
3.7%
8/219 • Number of events 27 • 6.75 years
|
1.9%
2/105 • Number of events 2 • 6.75 years
|
|
General disorders
Gen disord and admin site conds-Oth spec
|
6.0%
14/232 • Number of events 30 • 6.75 years
|
3.9%
9/233 • Number of events 18 • 6.75 years
|
2.7%
6/219 • Number of events 14 • 6.75 years
|
2.9%
3/105 • Number of events 8 • 6.75 years
|
|
General disorders
Generalized edema
|
0.00%
0/232 • 6.75 years
|
0.86%
2/233 • Number of events 3 • 6.75 years
|
0.46%
1/219 • Number of events 1 • 6.75 years
|
0.95%
1/105 • Number of events 4 • 6.75 years
|
|
General disorders
Hypothermia
|
0.00%
0/232 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.91%
2/219 • Number of events 2 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
General disorders
Infusion site extravasation
|
0.43%
1/232 • Number of events 1 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
General disorders
Localized edema
|
1.3%
3/232 • Number of events 7 • 6.75 years
|
0.43%
1/233 • Number of events 1 • 6.75 years
|
0.91%
2/219 • Number of events 7 • 6.75 years
|
0.95%
1/105 • Number of events 1 • 6.75 years
|
|
General disorders
Malaise
|
2.2%
5/232 • Number of events 15 • 6.75 years
|
1.3%
3/233 • Number of events 4 • 6.75 years
|
0.91%
2/219 • Number of events 8 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
General disorders
Multi-organ failure
|
0.00%
0/232 • 6.75 years
|
0.43%
1/233 • Number of events 1 • 6.75 years
|
1.4%
3/219 • Number of events 3 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
General disorders
Neck edema
|
0.00%
0/232 • 6.75 years
|
0.43%
1/233 • Number of events 2 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
General disorders
Non-cardiac chest pain
|
2.6%
6/232 • Number of events 13 • 6.75 years
|
3.4%
8/233 • Number of events 9 • 6.75 years
|
2.7%
6/219 • Number of events 6 • 6.75 years
|
1.9%
2/105 • Number of events 6 • 6.75 years
|
|
General disorders
Pain
|
6.9%
16/232 • Number of events 25 • 6.75 years
|
4.7%
11/233 • Number of events 22 • 6.75 years
|
5.5%
12/219 • Number of events 30 • 6.75 years
|
8.6%
9/105 • Number of events 20 • 6.75 years
|
|
General disorders
Sudden death NOS
|
0.00%
0/232 • 6.75 years
|
0.43%
1/233 • Number of events 1 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/232 • 6.75 years
|
0.86%
2/233 • Number of events 7 • 6.75 years
|
0.91%
2/219 • Number of events 2 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Hepatobiliary disorders
Gallbladder fistula
|
0.00%
0/232 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.46%
1/219 • Number of events 1 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Hepatobiliary disorders
Gallbladder obstruction
|
0.00%
0/232 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.46%
1/219 • Number of events 2 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Hepatobiliary disorders
Hepatic failure
|
0.43%
1/232 • Number of events 1 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
0.00%
0/232 • 6.75 years
|
0.43%
1/233 • Number of events 1 • 6.75 years
|
0.46%
1/219 • Number of events 1 • 6.75 years
|
0.95%
1/105 • Number of events 4 • 6.75 years
|
|
Immune system disorders
Allergic reaction
|
0.43%
1/232 • Number of events 1 • 6.75 years
|
1.3%
3/233 • Number of events 3 • 6.75 years
|
0.46%
1/219 • Number of events 1 • 6.75 years
|
0.95%
1/105 • Number of events 1 • 6.75 years
|
|
Immune system disorders
Anaphylaxis
|
0.43%
1/232 • Number of events 1 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Immune system disorders
Autoimmune disorder
|
0.00%
0/232 • 6.75 years
|
0.43%
1/233 • Number of events 1 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.95%
1/105 • Number of events 5 • 6.75 years
|
|
Immune system disorders
Immune system disorders - Other, specify
|
1.3%
3/232 • Number of events 4 • 6.75 years
|
0.43%
1/233 • Number of events 2 • 6.75 years
|
2.7%
6/219 • Number of events 32 • 6.75 years
|
2.9%
3/105 • Number of events 8 • 6.75 years
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/232 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.46%
1/219 • Number of events 1 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Infections and infestations
Appendicitis
|
0.00%
0/232 • 6.75 years
|
0.86%
2/233 • Number of events 2 • 6.75 years
|
0.91%
2/219 • Number of events 2 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Infections and infestations
Bacteremia
|
0.43%
1/232 • Number of events 1 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.91%
2/219 • Number of events 2 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Infections and infestations
Bladder infection
|
0.00%
0/232 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
1.4%
3/219 • Number of events 5 • 6.75 years
|
2.9%
3/105 • Number of events 3 • 6.75 years
|
|
Infections and infestations
Bone infection
|
0.43%
1/232 • Number of events 1 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Infections and infestations
Bronchial infection
|
0.00%
0/232 • 6.75 years
|
0.86%
2/233 • Number of events 3 • 6.75 years
|
0.91%
2/219 • Number of events 2 • 6.75 years
|
1.9%
2/105 • Number of events 2 • 6.75 years
|
|
Infections and infestations
Conjunctivitis
|
0.43%
1/232 • Number of events 1 • 6.75 years
|
1.3%
3/233 • Number of events 5 • 6.75 years
|
0.46%
1/219 • Number of events 3 • 6.75 years
|
0.95%
1/105 • Number of events 1 • 6.75 years
|
|
Infections and infestations
Conjunctivitis infective
|
0.00%
0/232 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.91%
2/219 • Number of events 2 • 6.75 years
|
0.95%
1/105 • Number of events 1 • 6.75 years
|
|
Infections and infestations
Enterocolitis infectious
|
0.86%
2/232 • Number of events 2 • 6.75 years
|
2.1%
5/233 • Number of events 7 • 6.75 years
|
1.4%
3/219 • Number of events 3 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Infections and infestations
Eye infection
|
0.00%
0/232 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
1.4%
3/219 • Number of events 7 • 6.75 years
|
0.95%
1/105 • Number of events 1 • 6.75 years
|
|
Infections and infestations
Folliculitis
|
0.86%
2/232 • Number of events 2 • 6.75 years
|
0.43%
1/233 • Number of events 1 • 6.75 years
|
1.4%
3/219 • Number of events 4 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Infections and infestations
Fungemia
|
0.00%
0/232 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.46%
1/219 • Number of events 3 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Infections and infestations
Gum infection
|
0.43%
1/232 • Number of events 2 • 6.75 years
|
0.43%
1/233 • Number of events 1 • 6.75 years
|
0.46%
1/219 • Number of events 1 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Infections and infestations
Hepatitis B reactivation
|
0.00%
0/232 • 6.75 years
|
0.43%
1/233 • Number of events 1 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.95%
1/105 • Number of events 3 • 6.75 years
|
|
Infections and infestations
Herpes simplex reactivation
|
1.7%
4/232 • Number of events 9 • 6.75 years
|
0.86%
2/233 • Number of events 6 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.95%
1/105 • Number of events 6 • 6.75 years
|
|
Infections and infestations
Infections and infestations - Oth spec
|
12.1%
28/232 • Number of events 40 • 6.75 years
|
18.5%
43/233 • Number of events 55 • 6.75 years
|
31.1%
68/219 • Number of events 93 • 6.75 years
|
20.0%
21/105 • Number of events 43 • 6.75 years
|
|
Infections and infestations
Joint infection
|
0.86%
2/232 • Number of events 2 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Infections and infestations
Lung infection
|
9.1%
21/232 • Number of events 25 • 6.75 years
|
12.0%
28/233 • Number of events 37 • 6.75 years
|
21.5%
47/219 • Number of events 76 • 6.75 years
|
10.5%
11/105 • Number of events 16 • 6.75 years
|
|
Infections and infestations
Nail infection
|
1.7%
4/232 • Number of events 4 • 6.75 years
|
0.43%
1/233 • Number of events 2 • 6.75 years
|
2.3%
5/219 • Number of events 7 • 6.75 years
|
0.95%
1/105 • Number of events 4 • 6.75 years
|
|
Infections and infestations
Otitis externa
|
0.43%
1/232 • Number of events 1 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.46%
1/219 • Number of events 3 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Infections and infestations
Otitis media
|
0.43%
1/232 • Number of events 2 • 6.75 years
|
1.3%
3/233 • Number of events 5 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Infections and infestations
Papulopustular rash
|
0.00%
0/232 • 6.75 years
|
0.43%
1/233 • Number of events 2 • 6.75 years
|
0.91%
2/219 • Number of events 7 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Infections and infestations
Paronychia
|
0.00%
0/232 • 6.75 years
|
0.43%
1/233 • Number of events 1 • 6.75 years
|
2.3%
5/219 • Number of events 10 • 6.75 years
|
0.95%
1/105 • Number of events 2 • 6.75 years
|
|
Infections and infestations
Penile infection
|
0.43%
1/232 • Number of events 1 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Infections and infestations
Peripheral nerve infection
|
0.43%
1/232 • Number of events 1 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/232 • 6.75 years
|
0.43%
1/233 • Number of events 1 • 6.75 years
|
0.46%
1/219 • Number of events 1 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Infections and infestations
Rash pustular
|
0.00%
0/232 • 6.75 years
|
0.43%
1/233 • Number of events 1 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Infections and infestations
Rhinitis infective
|
0.00%
0/232 • 6.75 years
|
0.43%
1/233 • Number of events 1 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Infections and infestations
Scrotal infection
|
0.00%
0/232 • 6.75 years
|
0.43%
1/233 • Number of events 1 • 6.75 years
|
0.46%
1/219 • Number of events 1 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Infections and infestations
Sepsis
|
2.6%
6/232 • Number of events 6 • 6.75 years
|
5.6%
13/233 • Number of events 14 • 6.75 years
|
3.7%
8/219 • Number of events 8 • 6.75 years
|
1.9%
2/105 • Number of events 2 • 6.75 years
|
|
Infections and infestations
Shingles
|
1.3%
3/232 • Number of events 4 • 6.75 years
|
1.7%
4/233 • Number of events 4 • 6.75 years
|
1.4%
3/219 • Number of events 5 • 6.75 years
|
0.95%
1/105 • Number of events 1 • 6.75 years
|
|
Infections and infestations
Sinusitis
|
3.0%
7/232 • Number of events 15 • 6.75 years
|
1.7%
4/233 • Number of events 7 • 6.75 years
|
5.9%
13/219 • Number of events 29 • 6.75 years
|
3.8%
4/105 • Number of events 20 • 6.75 years
|
|
Infections and infestations
Skin infection
|
3.4%
8/232 • Number of events 13 • 6.75 years
|
5.2%
12/233 • Number of events 18 • 6.75 years
|
8.7%
19/219 • Number of events 32 • 6.75 years
|
3.8%
4/105 • Number of events 5 • 6.75 years
|
|
Infections and infestations
Small intestine infection
|
0.00%
0/232 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.46%
1/219 • Number of events 1 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Infections and infestations
Soft tissue infection
|
0.43%
1/232 • Number of events 1 • 6.75 years
|
0.43%
1/233 • Number of events 1 • 6.75 years
|
0.46%
1/219 • Number of events 1 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Infections and infestations
Thrush
|
0.86%
2/232 • Number of events 2 • 6.75 years
|
0.43%
1/233 • Number of events 2 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Blood and lymphatic system disorders
Methemoglobinemia
|
0.00%
0/232 • 6.75 years
|
0.43%
1/233 • Number of events 1 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Cardiac disorders
Aortic valve disease
|
0.00%
0/232 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.91%
2/219 • Number of events 2 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Cardiac disorders
Atrial fibrillation
|
18.1%
42/232 • Number of events 131 • 6.75 years
|
22.7%
53/233 • Number of events 184 • 6.75 years
|
31.1%
68/219 • Number of events 298 • 6.75 years
|
17.1%
18/105 • Number of events 76 • 6.75 years
|
|
Cardiac disorders
Atrial flutter
|
1.7%
4/232 • Number of events 11 • 6.75 years
|
1.3%
3/233 • Number of events 3 • 6.75 years
|
1.8%
4/219 • Number of events 9 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/232 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.46%
1/219 • Number of events 4 • 6.75 years
|
0.95%
1/105 • Number of events 16 • 6.75 years
|
|
Cardiac disorders
Cardiac arrest
|
1.3%
3/232 • Number of events 3 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
1.3%
3/232 • Number of events 5 • 6.75 years
|
0.43%
1/233 • Number of events 1 • 6.75 years
|
4.1%
9/219 • Number of events 46 • 6.75 years
|
5.7%
6/105 • Number of events 44 • 6.75 years
|
|
Cardiac disorders
Chest pain - cardiac
|
3.0%
7/232 • Number of events 7 • 6.75 years
|
1.7%
4/233 • Number of events 5 • 6.75 years
|
1.4%
3/219 • Number of events 3 • 6.75 years
|
1.9%
2/105 • Number of events 5 • 6.75 years
|
|
Cardiac disorders
Conduction disorder
|
0.00%
0/232 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.95%
1/105 • Number of events 2 • 6.75 years
|
|
Cardiac disorders
Heart failure
|
2.2%
5/232 • Number of events 7 • 6.75 years
|
3.4%
8/233 • Number of events 9 • 6.75 years
|
2.3%
5/219 • Number of events 10 • 6.75 years
|
0.95%
1/105 • Number of events 1 • 6.75 years
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
0.43%
1/232 • Number of events 1 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Cardiac disorders
Mitral valve disease
|
0.00%
0/232 • 6.75 years
|
0.86%
2/233 • Number of events 2 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.95%
1/105 • Number of events 13 • 6.75 years
|
|
Cardiac disorders
Myocardial infarction
|
1.3%
3/232 • Number of events 3 • 6.75 years
|
1.7%
4/233 • Number of events 4 • 6.75 years
|
3.2%
7/219 • Number of events 7 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Cardiac disorders
Palpitations
|
7.8%
18/232 • Number of events 37 • 6.75 years
|
4.3%
10/233 • Number of events 15 • 6.75 years
|
1.4%
3/219 • Number of events 10 • 6.75 years
|
2.9%
3/105 • Number of events 3 • 6.75 years
|
|
Cardiac disorders
Paroxysmal atrial tachycardia
|
0.00%
0/232 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.46%
1/219 • Number of events 1 • 6.75 years
|
0.95%
1/105 • Number of events 16 • 6.75 years
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/232 • 6.75 years
|
0.43%
1/233 • Number of events 1 • 6.75 years
|
0.91%
2/219 • Number of events 2 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Cardiac disorders
Pericardial tamponade
|
0.00%
0/232 • 6.75 years
|
0.43%
1/233 • Number of events 1 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Cardiac disorders
Pericarditis
|
0.43%
1/232 • Number of events 1 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Cardiac disorders
Sinus bradycardia
|
4.3%
10/232 • Number of events 11 • 6.75 years
|
3.9%
9/233 • Number of events 26 • 6.75 years
|
8.2%
18/219 • Number of events 82 • 6.75 years
|
7.6%
8/105 • Number of events 25 • 6.75 years
|
|
Cardiac disorders
Sinus tachycardia
|
1.3%
3/232 • Number of events 3 • 6.75 years
|
3.0%
7/233 • Number of events 8 • 6.75 years
|
2.3%
5/219 • Number of events 5 • 6.75 years
|
1.9%
2/105 • Number of events 3 • 6.75 years
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.43%
1/232 • Number of events 1 • 6.75 years
|
0.43%
1/233 • Number of events 1 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.95%
1/105 • Number of events 16 • 6.75 years
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.43%
1/232 • Number of events 1 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/232 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.46%
1/219 • Number of events 1 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/232 • 6.75 years
|
0.43%
1/233 • Number of events 1 • 6.75 years
|
0.91%
2/219 • Number of events 2 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Congenital, familial and genetic disorders
Congen, family, genetic disord -Oth spec
|
0.00%
0/232 • 6.75 years
|
0.43%
1/233 • Number of events 1 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Gastrointestinal disorders
Diarrhea
|
37.5%
87/232 • Number of events 242 • 6.75 years
|
68.2%
159/233 • Number of events 559 • 6.75 years
|
40.2%
88/219 • Number of events 381 • 6.75 years
|
33.3%
35/105 • Number of events 103 • 6.75 years
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Oth spec
|
2.2%
5/232 • Number of events 5 • 6.75 years
|
0.86%
2/233 • Number of events 4 • 6.75 years
|
0.91%
2/219 • Number of events 15 • 6.75 years
|
4.8%
5/105 • Number of events 8 • 6.75 years
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/232 • 6.75 years
|
0.86%
2/233 • Number of events 2 • 6.75 years
|
0.91%
2/219 • Number of events 3 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Ear and labyrinth disorders
Hearing impaired
|
1.7%
4/232 • Number of events 8 • 6.75 years
|
2.1%
5/233 • Number of events 16 • 6.75 years
|
3.2%
7/219 • Number of events 51 • 6.75 years
|
3.8%
4/105 • Number of events 26 • 6.75 years
|
|
Ear and labyrinth disorders
Middle ear inflammation
|
0.00%
0/232 • 6.75 years
|
0.43%
1/233 • Number of events 1 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Ear and labyrinth disorders
Tinnitus
|
1.7%
4/232 • Number of events 18 • 6.75 years
|
1.3%
3/233 • Number of events 11 • 6.75 years
|
0.91%
2/219 • Number of events 10 • 6.75 years
|
1.9%
2/105 • Number of events 5 • 6.75 years
|
|
Ear and labyrinth disorders
Vertigo
|
0.86%
2/232 • Number of events 2 • 6.75 years
|
2.1%
5/233 • Number of events 13 • 6.75 years
|
0.91%
2/219 • Number of events 3 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.00%
0/232 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.95%
1/105 • Number of events 1 • 6.75 years
|
|
Endocrine disorders
Endocrine disorders - Other, specify
|
0.43%
1/232 • Number of events 1 • 6.75 years
|
0.43%
1/233 • Number of events 1 • 6.75 years
|
1.4%
3/219 • Number of events 5 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Endocrine disorders
Hyperparathyroidism
|
0.00%
0/232 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
1.4%
3/219 • Number of events 4 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/232 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.91%
2/219 • Number of events 5 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Endocrine disorders
Hypoparathyroidism
|
0.43%
1/232 • Number of events 2 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.46%
1/219 • Number of events 11 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Endocrine disorders
Hypothyroidism
|
0.43%
1/232 • Number of events 3 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
1.8%
4/219 • Number of events 21 • 6.75 years
|
2.9%
3/105 • Number of events 6 • 6.75 years
|
|
Endocrine disorders
Testosterone deficiency
|
0.00%
0/232 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.95%
1/105 • Number of events 9 • 6.75 years
|
|
Eye disorders
Blurred vision
|
3.0%
7/232 • Number of events 13 • 6.75 years
|
2.6%
6/233 • Number of events 11 • 6.75 years
|
3.2%
7/219 • Number of events 29 • 6.75 years
|
0.95%
1/105 • Number of events 1 • 6.75 years
|
|
Eye disorders
Cataract
|
1.3%
3/232 • Number of events 6 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
1.8%
4/219 • Number of events 16 • 6.75 years
|
2.9%
3/105 • Number of events 17 • 6.75 years
|
|
Eye disorders
Dry eye
|
0.86%
2/232 • Number of events 9 • 6.75 years
|
2.1%
5/233 • Number of events 14 • 6.75 years
|
1.8%
4/219 • Number of events 12 • 6.75 years
|
0.95%
1/105 • Number of events 11 • 6.75 years
|
|
Eye disorders
Eye disorders - Other, specify
|
2.6%
6/232 • Number of events 13 • 6.75 years
|
4.3%
10/233 • Number of events 25 • 6.75 years
|
5.0%
11/219 • Number of events 24 • 6.75 years
|
1.9%
2/105 • Number of events 2 • 6.75 years
|
|
Eye disorders
Eye pain
|
0.43%
1/232 • Number of events 1 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.95%
1/105 • Number of events 1 • 6.75 years
|
|
Eye disorders
Eyelid function disorder
|
0.00%
0/232 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.46%
1/219 • Number of events 1 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Eye disorders
Floaters
|
0.00%
0/232 • 6.75 years
|
0.43%
1/233 • Number of events 3 • 6.75 years
|
0.46%
1/219 • Number of events 3 • 6.75 years
|
0.95%
1/105 • Number of events 6 • 6.75 years
|
|
Eye disorders
Glaucoma
|
0.43%
1/232 • Number of events 2 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.46%
1/219 • Number of events 6 • 6.75 years
|
0.95%
1/105 • Number of events 12 • 6.75 years
|
|
Eye disorders
Periorbital edema
|
0.00%
0/232 • 6.75 years
|
0.43%
1/233 • Number of events 2 • 6.75 years
|
0.46%
1/219 • Number of events 1 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Eye disorders
Photophobia
|
0.43%
1/232 • Number of events 4 • 6.75 years
|
0.43%
1/233 • Number of events 3 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.95%
1/105 • Number of events 9 • 6.75 years
|
|
Eye disorders
Retinal vascular disorder
|
0.00%
0/232 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.46%
1/219 • Number of events 1 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Eye disorders
Uveitis
|
0.00%
0/232 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.46%
1/219 • Number of events 5 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Eye disorders
Vitreous hemorrhage
|
0.43%
1/232 • Number of events 2 • 6.75 years
|
0.43%
1/233 • Number of events 1 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Eye disorders
Watering eyes
|
0.43%
1/232 • Number of events 3 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.91%
2/219 • Number of events 5 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Gastrointestinal disorders
Abdominal distension
|
0.43%
1/232 • Number of events 1 • 6.75 years
|
0.86%
2/233 • Number of events 2 • 6.75 years
|
0.91%
2/219 • Number of events 4 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Gastrointestinal disorders
Abdominal pain
|
3.4%
8/232 • Number of events 18 • 6.75 years
|
6.0%
14/233 • Number of events 35 • 6.75 years
|
6.4%
14/219 • Number of events 26 • 6.75 years
|
5.7%
6/105 • Number of events 14 • 6.75 years
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/232 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.46%
1/219 • Number of events 2 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/232 • 6.75 years
|
0.43%
1/233 • Number of events 1 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Gastrointestinal disorders
Belching
|
0.86%
2/232 • Number of events 3 • 6.75 years
|
0.43%
1/233 • Number of events 1 • 6.75 years
|
0.46%
1/219 • Number of events 1 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Gastrointestinal disorders
Bloating
|
2.6%
6/232 • Number of events 11 • 6.75 years
|
2.1%
5/233 • Number of events 8 • 6.75 years
|
1.4%
3/219 • Number of events 5 • 6.75 years
|
1.9%
2/105 • Number of events 3 • 6.75 years
|
|
Gastrointestinal disorders
Cheilitis
|
0.43%
1/232 • Number of events 3 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/232 • 6.75 years
|
0.43%
1/233 • Number of events 1 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Gastrointestinal disorders
Colonic hemorrhage
|
0.43%
1/232 • Number of events 1 • 6.75 years
|
0.00%
0/233 • 6.75 years
|
0.46%
1/219 • Number of events 1 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Gastrointestinal disorders
Constipation
|
11.6%
27/232 • Number of events 59 • 6.75 years
|
10.7%
25/233 • Number of events 60 • 6.75 years
|
9.1%
20/219 • Number of events 40 • 6.75 years
|
15.2%
16/105 • Number of events 68 • 6.75 years
|
|
Gastrointestinal disorders
Dental caries
|
0.86%
2/232 • Number of events 3 • 6.75 years
|
0.43%
1/233 • Number of events 2 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.95%
1/105 • Number of events 15 • 6.75 years
|
|
Blood and lymphatic system disorders
Anemia
|
31.5%
73/232 • Number of events 197 • 6.75 years
|
37.3%
87/233 • Number of events 241 • 6.75 years
|
32.0%
70/219 • Number of events 217 • 6.75 years
|
27.6%
29/105 • Number of events 99 • 6.75 years
|
|
Blood and lymphatic system disorders
Blood and lymph sys disorders - Oth Spec
|
3.4%
8/232 • Number of events 40 • 6.75 years
|
2.1%
5/233 • Number of events 29 • 6.75 years
|
5.5%
12/219 • Number of events 79 • 6.75 years
|
6.7%
7/105 • Number of events 29 • 6.75 years
|
|
Blood and lymphatic system disorders
Bone marrow hypocellular
|
0.00%
0/232 • 6.75 years
|
0.43%
1/233 • Number of events 1 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Blood and lymphatic system disorders
Eosinophilia
|
1.3%
3/232 • Number of events 5 • 6.75 years
|
0.43%
1/233 • Number of events 1 • 6.75 years
|
0.46%
1/219 • Number of events 2 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.2%
5/232 • Number of events 5 • 6.75 years
|
3.0%
7/233 • Number of events 9 • 6.75 years
|
0.91%
2/219 • Number of events 3 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Blood and lymphatic system disorders
Hemolysis
|
0.86%
2/232 • Number of events 3 • 6.75 years
|
0.43%
1/233 • Number of events 1 • 6.75 years
|
0.00%
0/219 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
|
Blood and lymphatic system disorders
Leukocytosis
|
6.9%
16/232 • Number of events 23 • 6.75 years
|
7.7%
18/233 • Number of events 19 • 6.75 years
|
0.46%
1/219 • Number of events 1 • 6.75 years
|
0.00%
0/105 • 6.75 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60