Trial Outcomes & Findings for ACP-196 (Acalabrutinib), a Novel Bruton Tyrosine Kinase (BTK) Inhibitor, for Treatment of Chronic Lymphocytic Leukemia, Richter's Syndrome or Prolymphocytic Leukemia (NCT NCT02029443)
NCT ID: NCT02029443
Last Updated: 2026-02-06
Results Overview
Participants with clinically abnormal vital signs (blood pressure, respiratory rate, pulse rate, or body temperature) reported as TEAEs are reported.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE1/PHASE2
Target enrollment
306 participants
Primary outcome timeframe
Day 1 through the final data cutoff date (approximately 7 years 6 months)
Results posted on
2026-02-06
Participant Flow
Out of 306 enrolled participates, 5 participants were not treated with the study drug. The data of "All treated population" was collected and analyzed. The results data are reported per the primary completion date (data cut-off date of 15Jul2021). There will be no updated results for all outcome measures at the time of end of study.
Participant milestones
| Measure |
Relapsed/Refractory Cohort
Phase 1 (dose-escalation) and Phase 2 (dose-expansion) were conducted for participants with relapsed/refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). In Phase 1, participants received oral once daily (QD) acalabrutinib at Dose 1 (Cohort 1), Dose 2 (Cohort 2a), Dose 3 (Cohort 3), and Dose 4 (Cohort 4a), and twice daily (BID) acalabrutinib at Dose 1 (Cohort 2b) and Dose 5 (Cohort 4b) for 28 days (1 cycle). In Phase 2, participants received oral acalabrutinib at Dose 1 BID (Cohort 2b) or Dose 5 QD (Cohort 2c, later switched to Dose 1 BID per protocol amendment 6) until disease progression or until the investigator considered the study treatment to be intolerable or no longer in the participant's best interest. Participants from Phase 1 continued to receive Dose 1 BID until disease progression or until the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Treatment-naive Cohort
Treatment-naïve participants with confirmed CLL or SLL, received oral acalabrutinib Dose 5 QD (Cohort 7, later switched to Dose 1 BID per protocol amendment 6) or Dose 1 BID (Cohort 11) until disease progression or until the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Ibrutinib-intolerant Cohort
Participants with confirmed CLL or SLL and were not tolerating ibrutinib treatment, received oral acalabrutinib Dose 5 QD (Cohort 8a, later switched to Dose 1 BID per protocol amendment 4) or Dose 1 BID (Cohort 8b) until disease progression or until the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Richters Syndrome/Prolymphocytic Leukemia Transformation Cohort
Participants with diffuse large B-cell lymphoma (DLBCL) Richter's transformation (RS) or prolymphocytic leukemia transformation (PLL), received oral acalabrutinib Dose 5 BID (Cohort 9) until disease progression or until the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Ibrutinib Relapsed/Refractory Cohort
Participants with confirmed CLL/SLL and had relapsed/refractory to ibrutinib treatment, received oral acalabrutinib Dose 5 QD (Cohort 10) until disease progression or until the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
134
|
99
|
33
|
29
|
6
|
|
Overall Study
COMPLETED
|
41
|
70
|
6
|
3
|
0
|
|
Overall Study
NOT COMPLETED
|
93
|
29
|
27
|
26
|
6
|
Reasons for withdrawal
| Measure |
Relapsed/Refractory Cohort
Phase 1 (dose-escalation) and Phase 2 (dose-expansion) were conducted for participants with relapsed/refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). In Phase 1, participants received oral once daily (QD) acalabrutinib at Dose 1 (Cohort 1), Dose 2 (Cohort 2a), Dose 3 (Cohort 3), and Dose 4 (Cohort 4a), and twice daily (BID) acalabrutinib at Dose 1 (Cohort 2b) and Dose 5 (Cohort 4b) for 28 days (1 cycle). In Phase 2, participants received oral acalabrutinib at Dose 1 BID (Cohort 2b) or Dose 5 QD (Cohort 2c, later switched to Dose 1 BID per protocol amendment 6) until disease progression or until the investigator considered the study treatment to be intolerable or no longer in the participant's best interest. Participants from Phase 1 continued to receive Dose 1 BID until disease progression or until the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Treatment-naive Cohort
Treatment-naïve participants with confirmed CLL or SLL, received oral acalabrutinib Dose 5 QD (Cohort 7, later switched to Dose 1 BID per protocol amendment 6) or Dose 1 BID (Cohort 11) until disease progression or until the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Ibrutinib-intolerant Cohort
Participants with confirmed CLL or SLL and were not tolerating ibrutinib treatment, received oral acalabrutinib Dose 5 QD (Cohort 8a, later switched to Dose 1 BID per protocol amendment 4) or Dose 1 BID (Cohort 8b) until disease progression or until the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Richters Syndrome/Prolymphocytic Leukemia Transformation Cohort
Participants with diffuse large B-cell lymphoma (DLBCL) Richter's transformation (RS) or prolymphocytic leukemia transformation (PLL), received oral acalabrutinib Dose 5 BID (Cohort 9) until disease progression or until the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Ibrutinib Relapsed/Refractory Cohort
Participants with confirmed CLL/SLL and had relapsed/refractory to ibrutinib treatment, received oral acalabrutinib Dose 5 QD (Cohort 10) until disease progression or until the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
|---|---|---|---|---|---|
|
Overall Study
Completed 30-Day safety follow-up visit
|
53
|
16
|
12
|
2
|
1
|
|
Overall Study
Death
|
13
|
2
|
2
|
11
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
1
|
1
|
0
|
|
Overall Study
Started other anti-cancer therapy
|
17
|
4
|
7
|
9
|
3
|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
1
|
1
|
0
|
|
Overall Study
Other
|
6
|
6
|
4
|
2
|
0
|
Baseline Characteristics
ACP-196 (Acalabrutinib), a Novel Bruton Tyrosine Kinase (BTK) Inhibitor, for Treatment of Chronic Lymphocytic Leukemia, Richter's Syndrome or Prolymphocytic Leukemia
Baseline characteristics by cohort
| Measure |
Relapsed/Refractory Cohort
n=134 Participants
Phase 1 (dose-escalation) and Phase 2 (dose-expansion) were conducted for participants with relapsed/refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). In Phase 1, participants received oral once daily (QD) acalabrutinib at Dose 1 (Cohort 1), Dose 2 (Cohort 2a), Dose 3 (Cohort 3), and Dose 4 (Cohort 4a), and twice daily (BID) acalabrutinib at Dose 1 (Cohort 2b) and Dose 5 (Cohort 4b) for 28 days (1 cycle). In Phase 2, participants received oral acalabrutinib at Dose 1 BID (Cohort 2b) or Dose 5 QD (Cohort 2c, later switched to Dose 1 BID per protocol amendment 6) until disease progression or until the investigator considered the study treatment to be intolerable or no longer in the participant's best interest. Participants from Phase 1 continued to receive Dose 1 BID until disease progression or until the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Treatment-naive Cohort
n=99 Participants
Treatment-naïve participants with confirmed CLL or SLL, received oral acalabrutinib Dose 5 QD (Cohort 7, later switched to Dose 1 BID per protocol amendment 6) or Dose 1 BID (Cohort 11) until disease progression or until the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Ibrutinib-intolerant Cohort
n=33 Participants
Participants with confirmed CLL or SLL and were not tolerating ibrutinib treatment, received oral acalabrutinib Dose 5 QD (Cohort 8a, later switched to Dose 1 BID per protocol amendment 4) or Dose 1 BID (Cohort 8b) until disease progression or until the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Richters Syndrome/Prolymphocytic Leukemia Transformation Cohort
n=29 Participants
Participants with diffuse large B-cell lymphoma (DLBCL) Richter's transformation (RS) or prolymphocytic leukemia transformation (PLL), received oral acalabrutinib Dose 5 BID (Cohort 9) until disease progression or until the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Ibrutinib Relapsed/Refractory Cohort
n=6 Participants
Participants with confirmed CLL/SLL and had relapsed/refractory to ibrutinib treatment, received oral acalabrutinib Dose 5 QD (Cohort 10) until disease progression or until the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Total
n=301 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
65.6 Years
STANDARD_DEVIATION 9.2 • n=192 Participants
|
63.5 Years
STANDARD_DEVIATION 9.7 • n=170 Participants
|
63.9 Years
STANDARD_DEVIATION 8.9 • n=185 Participants
|
65.0 Years
STANDARD_DEVIATION 9.6 • n=177 Participants
|
62.5 Years
STANDARD_DEVIATION 7.9 • n=172 Participants
|
64.6 Years
STANDARD_DEVIATION 9.33 • n=896 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=192 Participants
|
33 Participants
n=170 Participants
|
13 Participants
n=185 Participants
|
14 Participants
n=177 Participants
|
3 Participants
n=172 Participants
|
98 Participants
n=896 Participants
|
|
Sex: Female, Male
Male
|
99 Participants
n=192 Participants
|
66 Participants
n=170 Participants
|
20 Participants
n=185 Participants
|
15 Participants
n=177 Participants
|
3 Participants
n=172 Participants
|
203 Participants
n=896 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=192 Participants
|
3 Participants
n=170 Participants
|
0 Participants
n=185 Participants
|
0 Participants
n=177 Participants
|
0 Participants
n=172 Participants
|
5 Participants
n=896 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
129 Participants
n=192 Participants
|
94 Participants
n=170 Participants
|
33 Participants
n=185 Participants
|
28 Participants
n=177 Participants
|
6 Participants
n=172 Participants
|
290 Participants
n=896 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=192 Participants
|
2 Participants
n=170 Participants
|
0 Participants
n=185 Participants
|
1 Participants
n=177 Participants
|
0 Participants
n=172 Participants
|
6 Participants
n=896 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=192 Participants
|
0 Participants
n=170 Participants
|
0 Participants
n=185 Participants
|
0 Participants
n=177 Participants
|
0 Participants
n=172 Participants
|
1 Participants
n=896 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=192 Participants
|
2 Participants
n=170 Participants
|
0 Participants
n=185 Participants
|
0 Participants
n=177 Participants
|
0 Participants
n=172 Participants
|
3 Participants
n=896 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=192 Participants
|
0 Participants
n=170 Participants
|
0 Participants
n=185 Participants
|
0 Participants
n=177 Participants
|
0 Participants
n=172 Participants
|
0 Participants
n=896 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=192 Participants
|
5 Participants
n=170 Participants
|
2 Participants
n=185 Participants
|
1 Participants
n=177 Participants
|
1 Participants
n=172 Participants
|
15 Participants
n=896 Participants
|
|
Race (NIH/OMB)
White
|
120 Participants
n=192 Participants
|
88 Participants
n=170 Participants
|
31 Participants
n=185 Participants
|
27 Participants
n=177 Participants
|
5 Participants
n=172 Participants
|
271 Participants
n=896 Participants
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=192 Participants
|
4 Participants
n=170 Participants
|
0 Participants
n=185 Participants
|
1 Participants
n=177 Participants
|
0 Participants
n=172 Participants
|
11 Participants
n=896 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=192 Participants
|
0 Participants
n=170 Participants
|
0 Participants
n=185 Participants
|
0 Participants
n=177 Participants
|
0 Participants
n=172 Participants
|
0 Participants
n=896 Participants
|
PRIMARY outcome
Timeframe: From Day 1 to Day 28 after first dose of study drugPopulation: All-treated population included all participants enrolled in Phase 1 (dose-escalation) of the study, received 1 or more doses of study drug, and observed from Day 1 to Day 28 after first dose of study drug.
Participants with DLTs in Phase 1 are reported. The DLT was defined as any of the following events unless the adverse event is clearly related to disease progression or the participant's current medical history and associated comorbidities: (1) Any Grade 3 or greater nonhematologic toxicity with the exceptions of alopecia and Grade 3 nausea, vomiting, and diarrhea that respond to supportive therapy; (2) Hematologic toxicities including Grade 4 neutropenia lasting more than 5 days, Grade 4 or Grade 3 thrombocytopenia with bleeding or any requirement for platelets transfusion, Grade 3 or greater febrile neutropenia (body temperature of 38.5 degrees Celsius or more), or Grade 4 anemia, unexplained by underlying disease; or (3) Dosing delay due to toxicity for \> 7 consecutive days.
Outcome measures
| Measure |
Cohort 4a
n=6 Participants
Participants with CLL received oral acalabrutinib Dose 4 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 4b
Participants with CLL received oral acalabrutinib Dose 5 BID (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 2a
n=8 Participants
Participants with CLL/SLL received oral acalabrutinib Dose 2 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 2b
n=29 Participants
Participants with CLL received oral acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 2c
n=7 Participants
Participants with CLL received oral acalabrutinib Dose 5 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 7
Treatment-naïve participants with CLL or SLL received oral acalabrutinib Dose 5 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 3
n=6 Participants
Participants with CLL received oral acalabrutinib Dose 3 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 8a
Participants with CLL or SLL and were not tolerating ibrutinib treatment, received oral acalabrutinib Dose 5 QD (which switched to Dose 1 BID per protocol amendment 4) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 8b
Participants with CLL or SLL and were not tolerating ibrutinib treatment, received oral acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 9
Participants with DLBCLRS or PLL transformation, received oral acalabrutinib Dose 5 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 10
Participants with CLL/SLL and had relapsed/refractory ibrutinib treatment, received oral acalabrutinib Dose 5 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 11
Treatment-naïve participants with CLL/SLL, received oral acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 1
n=9 Participants
Participants with CLL/SLL received oral acalabrutinib Dose 1 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicities (DLTs) in Phase 1
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 through the final data cutoff date (approximately 7 years 6 months)Population: All-treated population included all enrolled participants who received 1 or more doses of study drug.
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
Outcome measures
| Measure |
Cohort 4a
Participants with CLL received oral acalabrutinib Dose 4 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 4b
Participants with CLL received oral acalabrutinib Dose 5 BID (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 2a
n=99 Participants
Participants with CLL/SLL received oral acalabrutinib Dose 2 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 2b
n=33 Participants
Participants with CLL received oral acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 2c
n=29 Participants
Participants with CLL received oral acalabrutinib Dose 5 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 7
Treatment-naïve participants with CLL or SLL received oral acalabrutinib Dose 5 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 3
n=6 Participants
Participants with CLL received oral acalabrutinib Dose 3 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 8a
Participants with CLL or SLL and were not tolerating ibrutinib treatment, received oral acalabrutinib Dose 5 QD (which switched to Dose 1 BID per protocol amendment 4) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 8b
Participants with CLL or SLL and were not tolerating ibrutinib treatment, received oral acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 9
Participants with DLBCLRS or PLL transformation, received oral acalabrutinib Dose 5 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 10
Participants with CLL/SLL and had relapsed/refractory ibrutinib treatment, received oral acalabrutinib Dose 5 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 11
Treatment-naïve participants with CLL/SLL, received oral acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 1
n=134 Participants
Participants with CLL/SLL received oral acalabrutinib Dose 1 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
Any TEAEs
|
—
|
—
|
99 Participants
|
33 Participants
|
28 Participants
|
—
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
134 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
Any TESAEs
|
—
|
—
|
50 Participants
|
20 Participants
|
18 Participants
|
—
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
86 Participants
|
PRIMARY outcome
Timeframe: Day 1 through the final data cutoff date (approximately 7 years 6 months)Population: All-treated population included all enrolled participants who received 1 or more doses of study drug.
The treatment emergent ECI included the events identified based on preclinical findings, emerging data from clinical studies relating to acalabrutinib, and pharmacological effects of approved Bruton's tyrosine kinase (BTK) inhibitors and reported after the first dose of the study drug.
Outcome measures
| Measure |
Cohort 4a
Participants with CLL received oral acalabrutinib Dose 4 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 4b
Participants with CLL received oral acalabrutinib Dose 5 BID (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 2a
n=99 Participants
Participants with CLL/SLL received oral acalabrutinib Dose 2 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 2b
n=33 Participants
Participants with CLL received oral acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 2c
n=29 Participants
Participants with CLL received oral acalabrutinib Dose 5 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 7
Treatment-naïve participants with CLL or SLL received oral acalabrutinib Dose 5 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 3
n=6 Participants
Participants with CLL received oral acalabrutinib Dose 3 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 8a
Participants with CLL or SLL and were not tolerating ibrutinib treatment, received oral acalabrutinib Dose 5 QD (which switched to Dose 1 BID per protocol amendment 4) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 8b
Participants with CLL or SLL and were not tolerating ibrutinib treatment, received oral acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 9
Participants with DLBCLRS or PLL transformation, received oral acalabrutinib Dose 5 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 10
Participants with CLL/SLL and had relapsed/refractory ibrutinib treatment, received oral acalabrutinib Dose 5 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 11
Treatment-naïve participants with CLL/SLL, received oral acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 1
n=134 Participants
Participants with CLL/SLL received oral acalabrutinib Dose 1 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Events of Clinical Interest (ECI)
Other Leukopenia
|
—
|
—
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
2 Participants
|
|
Number of Participants With Treatment Emergent Events of Clinical Interest (ECI)
Hypertension
|
—
|
—
|
29 Participants
|
7 Participants
|
2 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
31 Participants
|
|
Number of Participants With Treatment Emergent Events of Clinical Interest (ECI)
Infections
|
—
|
—
|
86 Participants
|
25 Participants
|
18 Participants
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
118 Participants
|
|
Number of Participants With Treatment Emergent Events of Clinical Interest (ECI)
Tumor lysis syndrome
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
1 Participants
|
|
Number of Participants With Treatment Emergent Events of Clinical Interest (ECI)
Atrial fibrillation
|
—
|
—
|
6 Participants
|
4 Participants
|
3 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
12 Participants
|
|
Number of Participants With Treatment Emergent Events of Clinical Interest (ECI)
Ventricular tachyarrhythmias
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
2 Participants
|
|
Number of Participants With Treatment Emergent Events of Clinical Interest (ECI)
Anemia
|
—
|
—
|
10 Participants
|
4 Participants
|
10 Participants
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
22 Participants
|
|
Number of Participants With Treatment Emergent Events of Clinical Interest (ECI)
Neutropenia
|
—
|
—
|
9 Participants
|
5 Participants
|
13 Participants
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
26 Participants
|
|
Number of Participants With Treatment Emergent Events of Clinical Interest (ECI)
Thrombocytopenia
|
—
|
—
|
1 Participants
|
4 Participants
|
4 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
10 Participants
|
|
Number of Participants With Treatment Emergent Events of Clinical Interest (ECI)
Major hemorrhage
|
—
|
—
|
8 Participants
|
4 Participants
|
0 Participants
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
11 Participants
|
|
Number of Participants With Treatment Emergent Events of Clinical Interest (ECI)
Hepatotoxicity
|
—
|
—
|
4 Participants
|
1 Participants
|
3 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
4 Participants
|
|
Number of Participants With Treatment Emergent Events of Clinical Interest (ECI)
Interstitial lung disease/Pneumonitis
|
—
|
—
|
3 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
1 Participants
|
|
Number of Participants With Treatment Emergent Events of Clinical Interest (ECI)
Second primary malignancies, excluding non-melanoma skin
|
—
|
—
|
14 Participants
|
3 Participants
|
1 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
23 Participants
|
PRIMARY outcome
Timeframe: Day 1 through the final data cutoff date (approximately 7 years 6 months)Population: All-treated population included all enrolled participants who received 1 or more doses of study drug.
Participants with clinically important laboratory abnormalities with CTCAE Grade 3 or more are reported. Laboratory analysis included hematology, clinical chemistry, amylase, lipase, cardiac troponin I, hepatitis B and C testing, and urinalysis. The CTCAE version 4.03 is a descriptive terminology is used for AE reporting. The CTCAE v4.03 displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 3 as severe AE, Grade 4 as life-threatening or disabling AE, and Grade 5 as death related to AE.
Outcome measures
| Measure |
Cohort 4a
Participants with CLL received oral acalabrutinib Dose 4 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 4b
Participants with CLL received oral acalabrutinib Dose 5 BID (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 2a
n=99 Participants
Participants with CLL/SLL received oral acalabrutinib Dose 2 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 2b
n=33 Participants
Participants with CLL received oral acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 2c
n=29 Participants
Participants with CLL received oral acalabrutinib Dose 5 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 7
Treatment-naïve participants with CLL or SLL received oral acalabrutinib Dose 5 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 3
n=6 Participants
Participants with CLL received oral acalabrutinib Dose 3 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 8a
Participants with CLL or SLL and were not tolerating ibrutinib treatment, received oral acalabrutinib Dose 5 QD (which switched to Dose 1 BID per protocol amendment 4) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 8b
Participants with CLL or SLL and were not tolerating ibrutinib treatment, received oral acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 9
Participants with DLBCLRS or PLL transformation, received oral acalabrutinib Dose 5 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 10
Participants with CLL/SLL and had relapsed/refractory ibrutinib treatment, received oral acalabrutinib Dose 5 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 11
Treatment-naïve participants with CLL/SLL, received oral acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 1
n=134 Participants
Participants with CLL/SLL received oral acalabrutinib Dose 1 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Important Laboratory Abnormalities With Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or More
Absolute lymphocyte count (decreased)
|
—
|
—
|
7 Participants
|
2 Participants
|
6 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
20 Participants
|
|
Number of Participants With Clinically Important Laboratory Abnormalities With Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or More
Alkaline phosphatase (increased)
|
—
|
—
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
1 Participants
|
|
Number of Participants With Clinically Important Laboratory Abnormalities With Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or More
Amylase (increased)
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
2 Participants
|
|
Number of Participants With Clinically Important Laboratory Abnormalities With Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or More
Hemoglobin, platelets or neutrophils decreased
|
—
|
—
|
30 Participants
|
14 Participants
|
19 Participants
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
72 Participants
|
|
Number of Participants With Clinically Important Laboratory Abnormalities With Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or More
Absolute neutrophil count (decreased)
|
—
|
—
|
23 Participants
|
11 Participants
|
13 Participants
|
—
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
57 Participants
|
|
Number of Participants With Clinically Important Laboratory Abnormalities With Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or More
Hemoglobin (decreased)
|
—
|
—
|
5 Participants
|
3 Participants
|
8 Participants
|
—
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
17 Participants
|
|
Number of Participants With Clinically Important Laboratory Abnormalities With Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or More
Platelets (decreased)
|
—
|
—
|
3 Participants
|
4 Participants
|
5 Participants
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
20 Participants
|
|
Number of Participants With Clinically Important Laboratory Abnormalities With Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or More
Leukocytes (decreased)
|
—
|
—
|
2 Participants
|
3 Participants
|
6 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
12 Participants
|
|
Number of Participants With Clinically Important Laboratory Abnormalities With Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or More
Leukocytes (increased)
|
—
|
—
|
21 Participants
|
7 Participants
|
0 Participants
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
29 Participants
|
|
Number of Participants With Clinically Important Laboratory Abnormalities With Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or More
Absolute lymphocyte count (increased)
|
—
|
—
|
8 Participants
|
7 Participants
|
3 Participants
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
29 Participants
|
|
Number of Participants With Clinically Important Laboratory Abnormalities With Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or More
Urate (increased)
|
—
|
—
|
15 Participants
|
8 Participants
|
5 Participants
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
24 Participants
|
|
Number of Participants With Clinically Important Laboratory Abnormalities With Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or More
Sodium (decreased)
|
—
|
—
|
5 Participants
|
2 Participants
|
3 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
12 Participants
|
|
Number of Participants With Clinically Important Laboratory Abnormalities With Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or More
Phosphate (decreased)
|
—
|
—
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
9 Participants
|
|
Number of Participants With Clinically Important Laboratory Abnormalities With Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or More
Potassium (increased)
|
—
|
—
|
5 Participants
|
1 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
3 Participants
|
|
Number of Participants With Clinically Important Laboratory Abnormalities With Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or More
Glucose (increased)
|
—
|
—
|
1 Participants
|
3 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
3 Participants
|
|
Number of Participants With Clinically Important Laboratory Abnormalities With Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or More
Alanine aminotransferase (increased)
|
—
|
—
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
3 Participants
|
|
Number of Participants With Clinically Important Laboratory Abnormalities With Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or More
Calcium (increased)
|
—
|
—
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
5 Participants
|
|
Number of Participants With Clinically Important Laboratory Abnormalities With Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or More
Aspartate aminotransferase (increased)
|
—
|
—
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
2 Participants
|
|
Number of Participants With Clinically Important Laboratory Abnormalities With Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or More
Magnesium (increased)
|
—
|
—
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
2 Participants
|
|
Number of Participants With Clinically Important Laboratory Abnormalities With Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or More
Potassium (decreased)
|
—
|
—
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
2 Participants
|
|
Number of Participants With Clinically Important Laboratory Abnormalities With Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or More
Albumin (decreased)
|
—
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
2 Participants
|
|
Number of Participants With Clinically Important Laboratory Abnormalities With Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or More
Calcium (decreased)
|
—
|
—
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
2 Participants
|
|
Number of Participants With Clinically Important Laboratory Abnormalities With Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or More
Bilirubin (increased)
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
2 Participants
|
|
Number of Participants With Clinically Important Laboratory Abnormalities With Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or More
Creatinine (increased)
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
2 Participants
|
|
Number of Participants With Clinically Important Laboratory Abnormalities With Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or More
Lipase (increased)
|
—
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
1 Participants
|
PRIMARY outcome
Timeframe: Day 1 through the final data cutoff date (approximately 7 years 6 months)Population: All-treated population included all enrolled participants who received 1 or more doses of study drug.
Participants with clinically abnormal vital signs (blood pressure, respiratory rate, pulse rate, or body temperature) reported as TEAEs are reported.
Outcome measures
| Measure |
Cohort 4a
Participants with CLL received oral acalabrutinib Dose 4 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 4b
Participants with CLL received oral acalabrutinib Dose 5 BID (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 2a
n=99 Participants
Participants with CLL/SLL received oral acalabrutinib Dose 2 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 2b
n=33 Participants
Participants with CLL received oral acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 2c
n=29 Participants
Participants with CLL received oral acalabrutinib Dose 5 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 7
Treatment-naïve participants with CLL or SLL received oral acalabrutinib Dose 5 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 3
n=6 Participants
Participants with CLL received oral acalabrutinib Dose 3 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 8a
Participants with CLL or SLL and were not tolerating ibrutinib treatment, received oral acalabrutinib Dose 5 QD (which switched to Dose 1 BID per protocol amendment 4) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 8b
Participants with CLL or SLL and were not tolerating ibrutinib treatment, received oral acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 9
Participants with DLBCLRS or PLL transformation, received oral acalabrutinib Dose 5 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 10
Participants with CLL/SLL and had relapsed/refractory ibrutinib treatment, received oral acalabrutinib Dose 5 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 11
Treatment-naïve participants with CLL/SLL, received oral acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 1
n=134 Participants
Participants with CLL/SLL received oral acalabrutinib Dose 1 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Abnormal Vital Signs Reported as TEAEs
Blood pressure increased
|
—
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With Clinically Abnormal Vital Signs Reported as TEAEs
Dyspnoea
|
—
|
—
|
18 Participants
|
6 Participants
|
3 Participants
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
27 Participants
|
|
Number of Participants With Clinically Abnormal Vital Signs Reported as TEAEs
Dyspnoea exertional
|
—
|
—
|
5 Participants
|
1 Participants
|
0 Participants
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
5 Participants
|
|
Number of Participants With Clinically Abnormal Vital Signs Reported as TEAEs
Hypertension
|
—
|
—
|
28 Participants
|
6 Participants
|
1 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
30 Participants
|
|
Number of Participants With Clinically Abnormal Vital Signs Reported as TEAEs
Hypotension
|
—
|
—
|
12 Participants
|
5 Participants
|
1 Participants
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
7 Participants
|
|
Number of Participants With Clinically Abnormal Vital Signs Reported as TEAEs
Orthostatic hypotension
|
—
|
—
|
5 Participants
|
1 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With Clinically Abnormal Vital Signs Reported as TEAEs
Essential hypertension
|
—
|
—
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With Clinically Abnormal Vital Signs Reported as TEAEs
Hypertensive crisis
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
1 Participants
|
|
Number of Participants With Clinically Abnormal Vital Signs Reported as TEAEs
Malignant hypertension
|
—
|
—
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With Clinically Abnormal Vital Signs Reported as TEAEs
Palpitations
|
—
|
—
|
4 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
13 Participants
|
|
Number of Participants With Clinically Abnormal Vital Signs Reported as TEAEs
Tachycardia
|
—
|
—
|
8 Participants
|
2 Participants
|
3 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
3 Participants
|
|
Number of Participants With Clinically Abnormal Vital Signs Reported as TEAEs
Bradycardia
|
—
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
6 Participants
|
|
Number of Participants With Clinically Abnormal Vital Signs Reported as TEAEs
Pyrexia
|
—
|
—
|
14 Participants
|
10 Participants
|
6 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
39 Participants
|
|
Number of Participants With Clinically Abnormal Vital Signs Reported as TEAEs
Hyperpyrexia
|
—
|
—
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With Clinically Abnormal Vital Signs Reported as TEAEs
Hypothermia
|
—
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With Clinically Abnormal Vital Signs Reported as TEAEs
Procedural hypotension
|
—
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
PRIMARY outcome
Timeframe: Predose and at 0.25, 0.5, 0.75, 1, 2, 4, and 6 hours postdose on Day 1 and Day 8Population: Pharmacokinetic (PK) population included all participants who complied with the protocol sufficiently and displayed an evaluable PK profile (e.g. exposure to treatment, availability and integrity of measurements, and absence of major protocol violations). 'Number of participants analyzed' denotes the number of participants evaluated for this outcome measure. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
The AUC0-6 of acalabrutinib is reported.
Outcome measures
| Measure |
Cohort 4a
n=6 Participants
Participants with CLL received oral acalabrutinib Dose 4 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 4b
n=6 Participants
Participants with CLL received oral acalabrutinib Dose 5 BID (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 2a
n=7 Participants
Participants with CLL/SLL received oral acalabrutinib Dose 2 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 2b
n=24 Participants
Participants with CLL received oral acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 2c
n=12 Participants
Participants with CLL received oral acalabrutinib Dose 5 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 7
n=33 Participants
Treatment-naïve participants with CLL or SLL received oral acalabrutinib Dose 5 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 3
n=6 Participants
Participants with CLL received oral acalabrutinib Dose 3 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 8a
n=3 Participants
Participants with CLL or SLL and were not tolerating ibrutinib treatment, received oral acalabrutinib Dose 5 QD (which switched to Dose 1 BID per protocol amendment 4) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 8b
n=7 Participants
Participants with CLL or SLL and were not tolerating ibrutinib treatment, received oral acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 9
n=6 Participants
Participants with DLBCLRS or PLL transformation, received oral acalabrutinib Dose 5 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 10
n=5 Participants
Participants with CLL/SLL and had relapsed/refractory ibrutinib treatment, received oral acalabrutinib Dose 5 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 11
n=16 Participants
Treatment-naïve participants with CLL/SLL, received oral acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 1
n=8 Participants
Participants with CLL/SLL received oral acalabrutinib Dose 1 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time 0 to 6 Hours (AUC0-6) of Acalabrutinib
Day 1
|
2960 hr*ng/mL
Standard Deviation 1570
|
1950 hr*ng/mL
Standard Deviation 487
|
1250 hr*ng/mL
Standard Deviation 836
|
819 hr*ng/mL
Standard Deviation 493
|
2170 hr*ng/mL
Standard Deviation 1180
|
1740 hr*ng/mL
Standard Deviation 1540
|
1880 hr*ng/mL
Standard Deviation 1810
|
362 hr*ng/mL
Standard Deviation 221
|
670 hr*ng/mL
Standard Deviation 471
|
1690 hr*ng/mL
Standard Deviation 849
|
1100 hr*ng/mL
Standard Deviation 590
|
789 hr*ng/mL
Standard Deviation 398
|
971 hr*ng/mL
Standard Deviation 564
|
|
Area Under the Plasma Concentration-time Curve From Time 0 to 6 Hours (AUC0-6) of Acalabrutinib
Day 8
|
1630 hr*ng/mL
Standard Deviation 1050
|
1690 hr*ng/mL
Standard Deviation 1090
|
1180 hr*ng/mL
Standard Deviation 859
|
858 hr*ng/mL
Standard Deviation 419
|
1660 hr*ng/mL
Standard Deviation 554
|
1480 hr*ng/mL
Standard Deviation 986
|
1750 hr*ng/mL
Standard Deviation 518
|
2080 hr*ng/mL
Standard Deviation NA
Standard deviation (SD) was not calculated as only one participant was evaluated at the time of the analysis.
|
834 hr*ng/mL
Standard Deviation 713
|
1860 hr*ng/mL
Standard Deviation 786
|
1250 hr*ng/mL
Standard Deviation 1050
|
642 hr*ng/mL
Standard Deviation 310
|
631 hr*ng/mL
Standard Deviation 193
|
PRIMARY outcome
Timeframe: Predose and at 0.25, 0.5, 0.75, 1, 2, 4, 6, and 24 hours postdose on Day 1 and Day 8Population: The PK population included all participants who complied with the protocol sufficiently and displayed an evaluable PK profile (e.g. exposure to treatment, availability and integrity of measurements, and absence of major protocol violations). 'Number of participants analyzed' denotes the number of participants evaluated for this outcome measure. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
The AUC0-last of acalabrutinib is reported.
Outcome measures
| Measure |
Cohort 4a
n=6 Participants
Participants with CLL received oral acalabrutinib Dose 4 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 4b
n=6 Participants
Participants with CLL received oral acalabrutinib Dose 5 BID (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 2a
n=8 Participants
Participants with CLL/SLL received oral acalabrutinib Dose 2 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 2b
n=28 Participants
Participants with CLL received oral acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 2c
n=13 Participants
Participants with CLL received oral acalabrutinib Dose 5 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 7
n=37 Participants
Treatment-naïve participants with CLL or SLL received oral acalabrutinib Dose 5 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 3
n=7 Participants
Participants with CLL received oral acalabrutinib Dose 3 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 8a
n=3 Participants
Participants with CLL or SLL and were not tolerating ibrutinib treatment, received oral acalabrutinib Dose 5 QD (which switched to Dose 1 BID per protocol amendment 4) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 8b
n=8 Participants
Participants with CLL or SLL and were not tolerating ibrutinib treatment, received oral acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 9
n=10 Participants
Participants with DLBCLRS or PLL transformation, received oral acalabrutinib Dose 5 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 10
n=5 Participants
Participants with CLL/SLL and had relapsed/refractory ibrutinib treatment, received oral acalabrutinib Dose 5 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 11
n=17 Participants
Treatment-naïve participants with CLL/SLL, received oral acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 1
n=8 Participants
Participants with CLL/SLL received oral acalabrutinib Dose 1 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time 0 to Last Measurable Concentration (AUC0-last) of Acalabrutinib
Day 1
|
3430 hr*ng/mL
Standard Deviation 1640
|
1950 hr*ng/mL
Standard Deviation 487
|
1270 hr*ng/mL
Standard Deviation 775
|
795 hr*ng/mL
Standard Deviation 502
|
2280 hr*ng/mL
Standard Deviation 1060
|
1790 hr*ng/mL
Standard Deviation 1470
|
2030 hr*ng/mL
Standard Deviation 1670
|
539 hr*ng/mL
Standard Deviation 106
|
570 hr*ng/mL
Standard Deviation 451
|
1860 hr*ng/mL
Standard Deviation 1570
|
1100 hr*ng/mL
Standard Deviation 590
|
850 hr*ng/mL
Standard Deviation 462
|
1030 hr*ng/mL
Standard Deviation 529
|
|
Area Under the Plasma Concentration-time Curve From Time 0 to Last Measurable Concentration (AUC0-last) of Acalabrutinib
Day 8
|
1750 hr*ng/mL
Standard Deviation 979
|
1560 hr*ng/mL
Standard Deviation 1020
|
1180 hr*ng/mL
Standard Deviation 861
|
850 hr*ng/mL
Standard Deviation 660
|
1850 hr*ng/mL
Standard Deviation 882
|
1400 hr*ng/mL
Standard Deviation 929
|
2020 hr*ng/mL
Standard Deviation 1170
|
1180 hr*ng/mL
Standard Deviation NA
The SD could not be derived due to insufficient number of participants were evaluated at the time of the analysis.
|
748 hr*ng/mL
Standard Deviation 701
|
1710 hr*ng/mL
Standard Deviation 669
|
1260 hr*ng/mL
Standard Deviation 1060
|
660 hr*ng/mL
Standard Deviation 294
|
729 hr*ng/mL
Standard Deviation 380
|
PRIMARY outcome
Timeframe: Predose and at 0.25, 0.5, 0.75, 1, 2, 4, 6, and 24 hours postdose on Day 1 and Day 8Population: The PK population included all participants who complied with the protocol sufficiently and displayed an evaluable PK profile (e.g. exposure to treatment, availability and integrity of measurements, and absence of major protocol violations). 'Number of participants analyzed' denotes the number of participants evaluated for this outcome measure. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
The AUC0-inf of Acalabrutinib is reported.
Outcome measures
| Measure |
Cohort 4a
n=5 Participants
Participants with CLL received oral acalabrutinib Dose 4 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 4b
n=6 Participants
Participants with CLL received oral acalabrutinib Dose 5 BID (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 2a
n=7 Participants
Participants with CLL/SLL received oral acalabrutinib Dose 2 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 2b
n=24 Participants
Participants with CLL received oral acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 2c
n=11 Participants
Participants with CLL received oral acalabrutinib Dose 5 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 7
n=32 Participants
Treatment-naïve participants with CLL or SLL received oral acalabrutinib Dose 5 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 3
n=7 Participants
Participants with CLL received oral acalabrutinib Dose 3 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 8a
n=3 Participants
Participants with CLL or SLL and were not tolerating ibrutinib treatment, received oral acalabrutinib Dose 5 QD (which switched to Dose 1 BID per protocol amendment 4) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 8b
n=6 Participants
Participants with CLL or SLL and were not tolerating ibrutinib treatment, received oral acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 9
n=8 Participants
Participants with DLBCLRS or PLL transformation, received oral acalabrutinib Dose 5 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 10
n=4 Participants
Participants with CLL/SLL and had relapsed/refractory ibrutinib treatment, received oral acalabrutinib Dose 5 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 11
n=15 Participants
Treatment-naïve participants with CLL/SLL, received oral acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 1
n=8 Participants
Participants with CLL/SLL received oral acalabrutinib Dose 1 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of Acalabrutinib
Day 1
|
3250 hr*ng/mL
Standard Deviation 1630
|
1970 hr*ng/mL
Standard Deviation 495
|
1320 hr*ng/mL
Standard Deviation 827
|
855 hr*ng/mL
Standard Deviation 517
|
2440 hr*ng/mL
Standard Deviation 1010
|
1910 hr*ng/mL
Standard Deviation 1530
|
2050 hr*ng/mL
Standard Deviation 1680
|
574 hr*ng/mL
Standard Deviation 76.3
|
801 hr*ng/mL
Standard Deviation 410
|
1770 hr*ng/mL
Standard Deviation 776
|
1350 hr*ng/mL
Standard Deviation 373
|
940 hr*ng/mL
Standard Deviation 430
|
1040 hr*ng/mL
Standard Deviation 534
|
|
Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of Acalabrutinib
Day 8
|
1750 hr*ng/mL
Standard Deviation 1140
|
1780 hr*ng/mL
Standard Deviation 1230
|
1200 hr*ng/mL
Standard Deviation 865
|
956 hr*ng/mL
Standard Deviation 665
|
1990 hr*ng/mL
Standard Deviation 1020
|
1540 hr*ng/mL
Standard Deviation 973
|
2360 hr*ng/mL
Standard Deviation 1210
|
2120 hr*ng/mL
Standard Deviation NA
The SD could not be calculated as only one participant was evaluated at the time of the analysis.
|
963 hr*ng/mL
Standard Deviation 728
|
1750 hr*ng/mL
Standard Deviation 701
|
1580 hr*ng/mL
Standard Deviation 1030
|
652 hr*ng/mL
Standard Deviation 298
|
621 hr*ng/mL
Standard Deviation 187
|
PRIMARY outcome
Timeframe: Predose and at 0.25, 0.5, 0.75, 1, 2, 4, 6, and 24 hours postdose on Day 1 and Day 8Population: The PK population included all participants who complied with the protocol sufficiently and displayed an evaluable PK profile (e.g. exposure to treatment, availability and integrity of measurements, and absence of major protocol violations). 'Number of participants analyzed' denotes the number of participants evaluated for this outcome measure. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
The Cmax of Acalabrutinib is reported.
Outcome measures
| Measure |
Cohort 4a
n=5 Participants
Participants with CLL received oral acalabrutinib Dose 4 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 4b
n=6 Participants
Participants with CLL received oral acalabrutinib Dose 5 BID (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 2a
n=8 Participants
Participants with CLL/SLL received oral acalabrutinib Dose 2 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 2b
n=28 Participants
Participants with CLL received oral acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 2c
n=13 Participants
Participants with CLL received oral acalabrutinib Dose 5 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 7
n=37 Participants
Treatment-naïve participants with CLL or SLL received oral acalabrutinib Dose 5 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 3
n=7 Participants
Participants with CLL received oral acalabrutinib Dose 3 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 8a
n=3 Participants
Participants with CLL or SLL and were not tolerating ibrutinib treatment, received oral acalabrutinib Dose 5 QD (which switched to Dose 1 BID per protocol amendment 4) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 8b
n=8 Participants
Participants with CLL or SLL and were not tolerating ibrutinib treatment, received oral acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 9
n=10 Participants
Participants with DLBCLRS or PLL transformation, received oral acalabrutinib Dose 5 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 10
n=5 Participants
Participants with CLL/SLL and had relapsed/refractory ibrutinib treatment, received oral acalabrutinib Dose 5 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 11
n=16 Participants
Treatment-naïve participants with CLL/SLL, received oral acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 1
n=8 Participants
Participants with CLL/SLL received oral acalabrutinib Dose 1 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Acalabrutinib
Day 1
|
1550 ng/mL
Standard Deviation 1230
|
1600 ng/mL
Standard Deviation 291
|
754 ng/mL
Standard Deviation 540
|
706 ng/mL
Standard Deviation 499
|
1950 ng/mL
Standard Deviation 1460
|
1390 ng/mL
Standard Deviation 1260
|
1350 ng/mL
Standard Deviation 1170
|
206 ng/mL
Standard Deviation 240
|
554 ng/mL
Standard Deviation 500
|
1190 ng/mL
Standard Deviation 925
|
727 ng/mL
Standard Deviation 436
|
930 ng/mL
Standard Deviation 595
|
685 ng/mL
Standard Deviation 475
|
|
Maximum Observed Plasma Concentration (Cmax) of Acalabrutinib
Day 8
|
902 ng/mL
Standard Deviation 638
|
1320 ng/mL
Standard Deviation 1540
|
805 ng/mL
Standard Deviation 757
|
812 ng/mL
Standard Deviation 829
|
1350 ng/mL
Standard Deviation 809
|
1020 ng/mL
Standard Deviation 747
|
1350 ng/mL
Standard Deviation 933
|
939 ng/mL
Standard Deviation NA
The SD was not calculated due to insufficient number of participants were evaluated at the time of the analysis.
|
616 ng/mL
Standard Deviation 660
|
1460 ng/mL
Standard Deviation 913
|
610 ng/mL
Standard Deviation 751
|
633 ng/mL
Standard Deviation 449
|
521 ng/mL
Standard Deviation 308
|
PRIMARY outcome
Timeframe: Predose and at 0.25, 0.5, 0.75, 1, 2, 4, 6, and 24 hours postdose on Day 1 and Day 8Population: The PK population included all participants who complied with the protocol sufficiently and displayed an evaluable PK profile (e.g. exposure to treatment, availability and integrity of measurements, and absence of major protocol violations). 'Number of participants analyzed' denotes the number of participants evaluated for this outcome measure. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
The Tmax of Acalabrutinib is reported.
Outcome measures
| Measure |
Cohort 4a
n=5 Participants
Participants with CLL received oral acalabrutinib Dose 4 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 4b
n=6 Participants
Participants with CLL received oral acalabrutinib Dose 5 BID (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 2a
n=8 Participants
Participants with CLL/SLL received oral acalabrutinib Dose 2 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 2b
n=28 Participants
Participants with CLL received oral acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 2c
n=13 Participants
Participants with CLL received oral acalabrutinib Dose 5 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 7
n=37 Participants
Treatment-naïve participants with CLL or SLL received oral acalabrutinib Dose 5 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 3
n=7 Participants
Participants with CLL received oral acalabrutinib Dose 3 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 8a
n=3 Participants
Participants with CLL or SLL and were not tolerating ibrutinib treatment, received oral acalabrutinib Dose 5 QD (which switched to Dose 1 BID per protocol amendment 4) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 8b
n=8 Participants
Participants with CLL or SLL and were not tolerating ibrutinib treatment, received oral acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 9
n=10 Participants
Participants with DLBCLRS or PLL transformation, received oral acalabrutinib Dose 5 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 10
n=5 Participants
Participants with CLL/SLL and had relapsed/refractory ibrutinib treatment, received oral acalabrutinib Dose 5 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 11
n=16 Participants
Treatment-naïve participants with CLL/SLL, received oral acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 1
n=8 Participants
Participants with CLL/SLL received oral acalabrutinib Dose 1 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time of Maximum Plasma Concentration (Tmax) of Acalabrutinib
Day 1
|
1.00 Hours
Interval 0.75 to 4.0
|
0.758 Hours
Interval 0.25 to 1.08
|
0.917 Hours
Interval 0.5 to 3.83
|
0.750 Hours
Interval 0.5 to 2.3
|
1.00 Hours
Interval 0.25 to 5.92
|
0.783 Hours
Interval 0.25 to 2.1
|
1.00 Hours
Interval 0.5 to 1.83
|
1.30 Hours
Interval 0.75 to 2.2
|
0.783 Hours
Interval 0.5 to 5.83
|
0.992 Hours
Interval 0.5 to 4.05
|
1.00 Hours
Interval 0.5 to 1.08
|
0.642 Hours
Interval 0.483 to 2.0
|
1.01 Hours
Interval 0.417 to 2.0
|
|
Time of Maximum Plasma Concentration (Tmax) of Acalabrutinib
Day 8
|
0.700 Hours
Interval 0.5 to 1.95
|
0.758 Hours
Interval 0.5 to 2.07
|
0.517 Hours
Interval 0.467 to 1.0
|
0.750 Hours
Interval 0.45 to 5.75
|
1.03 Hours
Interval 0.5 to 2.1
|
0.750 Hours
Interval 0.25 to 2.22
|
1.00 Hours
Interval 0.5 to 1.97
|
1.49 Hours
Interval 1.08 to 1.9
|
0.908 Hours
Interval 0.467 to 2.03
|
1.00 Hours
Interval 0.5 to 2.08
|
1.58 Hours
Interval 0.467 to 4.08
|
0.533 Hours
Interval 0.25 to 1.85
|
1.05 Hours
Interval 0.5 to 1.17
|
PRIMARY outcome
Timeframe: Predose and at 0.25, 0.5, 0.75, 1, 2, 4, 6, and 24 hours postdose on Day 1 and Day 8Population: The PK population included all participants who complied with the protocol sufficiently and displayed an evaluable PK profile (e.g. exposure to treatment, availability and integrity of measurements, and absence of major protocol violations). 'Number of participants analyzed' denotes the number of participants evaluated for this outcome measure. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
The t1/2 of acalabrutinib is reported.
Outcome measures
| Measure |
Cohort 4a
n=5 Participants
Participants with CLL received oral acalabrutinib Dose 4 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 4b
n=6 Participants
Participants with CLL received oral acalabrutinib Dose 5 BID (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 2a
n=7 Participants
Participants with CLL/SLL received oral acalabrutinib Dose 2 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 2b
n=24 Participants
Participants with CLL received oral acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 2c
n=11 Participants
Participants with CLL received oral acalabrutinib Dose 5 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 7
n=32 Participants
Treatment-naïve participants with CLL or SLL received oral acalabrutinib Dose 5 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 3
n=7 Participants
Participants with CLL received oral acalabrutinib Dose 3 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 8a
n=3 Participants
Participants with CLL or SLL and were not tolerating ibrutinib treatment, received oral acalabrutinib Dose 5 QD (which switched to Dose 1 BID per protocol amendment 4) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 8b
n=6 Participants
Participants with CLL or SLL and were not tolerating ibrutinib treatment, received oral acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 9
n=8 Participants
Participants with DLBCLRS or PLL transformation, received oral acalabrutinib Dose 5 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 10
n=4 Participants
Participants with CLL/SLL and had relapsed/refractory ibrutinib treatment, received oral acalabrutinib Dose 5 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 11
n=15 Participants
Treatment-naïve participants with CLL/SLL, received oral acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 1
n=8 Participants
Participants with CLL/SLL received oral acalabrutinib Dose 1 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Terminal Elimination Half-life (t1/2) of Acalabrutinib
Day 1
|
3.52 Hours
Standard Deviation 4.93
|
0.869 Hours
Standard Deviation 0.0811
|
1.44 Hours
Standard Deviation 1.60
|
0.914 Hours
Standard Deviation 0.452
|
0.993 Hours
Standard Deviation 0.303
|
1.41 Hours
Standard Deviation 1.73
|
2.89 Hours
Standard Deviation 3.12
|
4.83 Hours
Standard Deviation 3.69
|
0.900 Hours
Standard Deviation 0.140
|
0.798 Hours
Standard Deviation 0.0973
|
1.01 Hours
Standard Deviation 0.209
|
0.781 Hours
Standard Deviation 0.137
|
1.48 Hours
Standard Deviation 1.50
|
|
Terminal Elimination Half-life (t1/2) of Acalabrutinib
Day 8
|
1.38 Hours
Standard Deviation 0.546
|
1.13 Hours
Standard Deviation 0.408
|
0.942 Hours
Standard Deviation 0.107
|
0.995 Hours
Standard Deviation 0.621
|
0.902 Hours
Standard Deviation 0.187
|
1.02 Hours
Standard Deviation 0.454
|
0.886 Hours
Standard Deviation 0.131
|
0.914 Hours
Standard Deviation NA
The SD was not calculated as only one participant was evaluated at the time of the analysis.
|
1.25 Hours
Standard Deviation 0.494
|
0.867 Hours
Standard Deviation 0.289
|
1.67 Hours
Standard Deviation 1.41
|
0.811 Hours
Standard Deviation 0.174
|
1.09 Hours
Standard Deviation 0.216
|
PRIMARY outcome
Timeframe: Predose and at 0.25, 0.5, 0.75, 1, 2, 4, 6, and 24 hours postdose on Day 1 and Day 8Population: The PK population included all participants who complied with the protocol sufficiently and displayed an evaluable PK profile (e.g. exposure to treatment, availability and integrity of measurements, and absence of major protocol violations). 'Number of participants analyzed' denotes the number of participants evaluated for this outcome measure. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
The λz of acalabrutinib is reported.
Outcome measures
| Measure |
Cohort 4a
n=5 Participants
Participants with CLL received oral acalabrutinib Dose 4 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 4b
n=6 Participants
Participants with CLL received oral acalabrutinib Dose 5 BID (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 2a
n=7 Participants
Participants with CLL/SLL received oral acalabrutinib Dose 2 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 2b
n=24 Participants
Participants with CLL received oral acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 2c
n=11 Participants
Participants with CLL received oral acalabrutinib Dose 5 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 7
n=32 Participants
Treatment-naïve participants with CLL or SLL received oral acalabrutinib Dose 5 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 3
n=7 Participants
Participants with CLL received oral acalabrutinib Dose 3 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 8a
n=3 Participants
Participants with CLL or SLL and were not tolerating ibrutinib treatment, received oral acalabrutinib Dose 5 QD (which switched to Dose 1 BID per protocol amendment 4) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 8b
n=6 Participants
Participants with CLL or SLL and were not tolerating ibrutinib treatment, received oral acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 9
n=8 Participants
Participants with DLBCLRS or PLL transformation, received oral acalabrutinib Dose 5 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 10
n=4 Participants
Participants with CLL/SLL and had relapsed/refractory ibrutinib treatment, received oral acalabrutinib Dose 5 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 11
n=15 Participants
Treatment-naïve participants with CLL/SLL, received oral acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 1
n=8 Participants
Participants with CLL/SLL received oral acalabrutinib Dose 1 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Terminal Elimination Rate Constant (λz) of Acalabrutinib
Day 1
|
0.557 1/hr
Standard Deviation 0.386
|
0.804 1/hr
Standard Deviation 0.0793
|
0.750 1/hr
Standard Deviation 0.307
|
0.848 1/hr
Standard Deviation 0.214
|
0.755 1/hr
Standard Deviation 0.209
|
0.756 1/hr
Standard Deviation 0.292
|
0.502 1/hr
Standard Deviation 0.300
|
0.373 1/hr
Standard Deviation 0.468
|
0.784 1/hr
Standard Deviation 0.112
|
0.880 1/hr
Standard Deviation 0.114
|
0.706 1/hr
Standard Deviation 0.144
|
0.916 1/hr
Standard Deviation 0.177
|
0.679 1/hr
Standard Deviation 0.276
|
|
Terminal Elimination Rate Constant (λz) of Acalabrutinib
Day 8
|
0.578 1/hr
Standard Deviation 0.243
|
0.679 1/hr
Standard Deviation 0.251
|
0.744 1/hr
Standard Deviation 0.0866
|
0.793 1/hr
Standard Deviation 0.191
|
0.798 1/hr
Standard Deviation 0.161
|
0.745 1/hr
Standard Deviation 0.174
|
0.797 1/hr
Standard Deviation 0.128
|
0.758 1/hr
Standard Deviation NA
The SD was not calculated as only one participant was evaluated at the time of the analysis.
|
0.623 1/hr
Standard Deviation 0.218
|
0.857 1/hr
Standard Deviation 0.209
|
0.603 1/hr
Standard Deviation 0.324
|
0.894 1/hr
Standard Deviation 0.204
|
0.655 1/hr
Standard Deviation 0.132
|
PRIMARY outcome
Timeframe: Predose and at 0.25, 0.5, 0.75, 1, 2, 4, 6, and 24 hours postdose on Day 1 and Day 8Population: The PK population included all participants who complied with the protocol sufficiently and displayed an evaluable PK profile (e.g. exposure to treatment, availability and integrity of measurements, and absence of major protocol violations). 'Number of participants analyzed' denotes the number of participants evaluated for this outcome measure. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
The CL/F of acalabrutinib is reported.
Outcome measures
| Measure |
Cohort 4a
n=5 Participants
Participants with CLL received oral acalabrutinib Dose 4 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 4b
n=6 Participants
Participants with CLL received oral acalabrutinib Dose 5 BID (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 2a
n=7 Participants
Participants with CLL/SLL received oral acalabrutinib Dose 2 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 2b
n=24 Participants
Participants with CLL received oral acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 2c
n=11 Participants
Participants with CLL received oral acalabrutinib Dose 5 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 7
n=32 Participants
Treatment-naïve participants with CLL or SLL received oral acalabrutinib Dose 5 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 3
n=7 Participants
Participants with CLL received oral acalabrutinib Dose 3 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 8a
n=3 Participants
Participants with CLL or SLL and were not tolerating ibrutinib treatment, received oral acalabrutinib Dose 5 QD (which switched to Dose 1 BID per protocol amendment 4) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 8b
n=6 Participants
Participants with CLL or SLL and were not tolerating ibrutinib treatment, received oral acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 9
n=8 Participants
Participants with DLBCLRS or PLL transformation, received oral acalabrutinib Dose 5 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 10
n=4 Participants
Participants with CLL/SLL and had relapsed/refractory ibrutinib treatment, received oral acalabrutinib Dose 5 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 11
n=15 Participants
Treatment-naïve participants with CLL/SLL, received oral acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 1
n=8 Participants
Participants with CLL/SLL received oral acalabrutinib Dose 1 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Oral Clearance (CL/F) of Acalabrutinib
Day 1
|
169 L/hr
Standard Deviation 123
|
108 L/hr
Standard Deviation 32.0
|
193 L/hr
Standard Deviation 121
|
212 L/hr
Standard Deviation 302
|
112 L/hr
Standard Deviation 98.4
|
315 L/hr
Standard Deviation 488
|
265 L/hr
Standard Deviation 263
|
352 L/hr
Standard Deviation 43.7
|
311 L/hr
Standard Deviation 166
|
142 L/hr
Standard Deviation 88.9
|
156 L/hr
Standard Deviation 40.3
|
137 L/hr
Standard Deviation 77.4
|
114 L/hr
Standard Deviation 44.4
|
|
Apparent Oral Clearance (CL/F) of Acalabrutinib
Day 8
|
344 L/hr
Standard Deviation 242
|
191 L/hr
Standard Deviation 180
|
216 L/hr
Standard Deviation 154
|
162 L/hr
Standard Deviation 141
|
122 L/hr
Standard Deviation 55.5
|
389 L/hr
Standard Deviation 1070
|
131 L/hr
Standard Deviation 70.3
|
94.5 L/hr
Standard Deviation NA
The SD was not calculated as only one participant was evaluated at the time of the analysis.
|
336 L/hr
Standard Deviation 258
|
132 L/hr
Standard Deviation 51.8
|
167 L/hr
Standard Deviation 95.1
|
188 L/hr
Standard Deviation 92.5
|
176 L/hr
Standard Deviation 62.1
|
PRIMARY outcome
Timeframe: Predose and at 0.25, 0.5, 0.75, 1, 2, 4, 6, and 24 hours postdose on Day 1 and Day 8Population: The PK population included all participants who complied with the protocol sufficiently and displayed an evaluable PK profile (e.g. exposure to treatment, availability and integrity of measurements, and absence of major protocol violations). 'Number of participants analyzed' denotes the number of participants evaluated for this outcome measure. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
The Vz/F of acalabrutinib is reported.
Outcome measures
| Measure |
Cohort 4a
n=5 Participants
Participants with CLL received oral acalabrutinib Dose 4 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 4b
n=6 Participants
Participants with CLL received oral acalabrutinib Dose 5 BID (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 2a
n=7 Participants
Participants with CLL/SLL received oral acalabrutinib Dose 2 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 2b
n=24 Participants
Participants with CLL received oral acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 2c
n=11 Participants
Participants with CLL received oral acalabrutinib Dose 5 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 7
n=32 Participants
Treatment-naïve participants with CLL or SLL received oral acalabrutinib Dose 5 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 3
n=7 Participants
Participants with CLL received oral acalabrutinib Dose 3 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 8a
n=3 Participants
Participants with CLL or SLL and were not tolerating ibrutinib treatment, received oral acalabrutinib Dose 5 QD (which switched to Dose 1 BID per protocol amendment 4) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 8b
n=6 Participants
Participants with CLL or SLL and were not tolerating ibrutinib treatment, received oral acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 9
n=8 Participants
Participants with DLBCLRS or PLL transformation, received oral acalabrutinib Dose 5 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 10
n=4 Participants
Participants with CLL/SLL and had relapsed/refractory ibrutinib treatment, received oral acalabrutinib Dose 5 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 11
n=15 Participants
Treatment-naïve participants with CLL/SLL, received oral acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 1
n=8 Participants
Participants with CLL/SLL received oral acalabrutinib Dose 1 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Volume of Distribution (Vz/F) of Acalabrutinib
Day 1
|
1480 L
Standard Deviation 2850
|
133 L
Standard Deviation 30.0
|
574 L
Standard Deviation 992
|
450 L
Standard Deviation 1250
|
182 L
Standard Deviation 230
|
930 L
Standard Deviation 1750
|
2100 L
Standard Deviation 3290
|
2600 L
Standard Deviation 2030
|
422 L
Standard Deviation 290
|
171 L
Standard Deviation 125
|
235 L
Standard Deviation 105
|
158 L
Standard Deviation 102
|
268 L
Standard Deviation 332
|
|
Apparent Volume of Distribution (Vz/F) of Acalabrutinib
Day 8
|
739 L
Standard Deviation 745
|
384 L
Standard Deviation 466
|
302 L
Standard Deviation 238
|
333 L
Standard Deviation 729
|
165 L
Standard Deviation 104
|
1180 L
Standard Deviation 4940
|
172 L
Standard Deviation 114
|
125 L
Standard Deviation NA
The SD was not calculated as only one participant was evaluated at the time of the analysis.
|
726 L
Standard Deviation 814
|
179 L
Standard Deviation 134
|
533 L
Standard Deviation 716
|
234 L
Standard Deviation 162
|
286 L
Standard Deviation 150
|
SECONDARY outcome
Timeframe: Day 1 through the final data cutoff date (approximately 7 years 6 months)Population: Efficacy evaluable population included all enrolled participants who received 1 or more doses of study drug and had 1 or more response assessments after the first dose of study drug.
For CLL/SLL, OR is defined as complete remission (CR), CR with incomplete marrow recovery (CRi), or partial remission (PR). CR: lymphocytes (lympho) \<4×10\^9/L, normocellular bone marrow (BM), normal lymph nodes (NLN), liver and spleen (L/S), absolute neutrophil count (ANC) \>1.5×10\^9/L, platelets \>100×10\^9/L, hemoglobin (Hb) \>11g/dL. Cri: lympho \<4×10\^9/L, hypocellular BM, NLN, L/S, persistent anemia, hrombocytopenia, or neutropenia. PR: \>=50% reduction in lymphadenopathy and/or enlargement of L/S or lympho (\<5×10\^9/L or \>=50% decrease from baseline) and criteria of ANC/platelets/Hb per CR or \>=50% improvement over baseline. Hematology result were without exogenous growth factors/transfusion. For RS, OR as CR or PR by Cheson et al. 2014 based on PET/CT scans and bone marrow. CR: disappearance of all detectable clinical evidence of disease and disease-related symptoms and PR: \>=50% decrease in sum of the product diameter of 6 largest nodal masses and no new sites of disease.
Outcome measures
| Measure |
Cohort 4a
n=6 Participants
Participants with CLL received oral acalabrutinib Dose 4 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 4b
n=6 Participants
Participants with CLL received oral acalabrutinib Dose 5 BID (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 2a
n=8 Participants
Participants with CLL/SLL received oral acalabrutinib Dose 2 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 2b
n=63 Participants
Participants with CLL received oral acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 2c
n=32 Participants
Participants with CLL received oral acalabrutinib Dose 5 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 7
n=37 Participants
Treatment-naïve participants with CLL or SLL received oral acalabrutinib Dose 5 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 3
n=7 Participants
Participants with CLL received oral acalabrutinib Dose 3 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 8a
n=60 Participants
Participants with CLL or SLL and were not tolerating ibrutinib treatment, received oral acalabrutinib Dose 5 QD (which switched to Dose 1 BID per protocol amendment 4) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 8b
Participants with CLL or SLL and were not tolerating ibrutinib treatment, received oral acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 9
Participants with DLBCLRS or PLL transformation, received oral acalabrutinib Dose 5 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 10
Participants with CLL/SLL and had relapsed/refractory ibrutinib treatment, received oral acalabrutinib Dose 5 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 11
Treatment-naïve participants with CLL/SLL, received oral acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 1
n=8 Participants
Participants with CLL/SLL received oral acalabrutinib Dose 1 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Objective Response (OR) as Assessed by the Investigator
|
100.0 Percentage of participants
Interval 54.1 to 100.0
|
100.0 Percentage of participants
Interval 54.1 to 100.0
|
75 Percentage of participants
Interval 34.9 to 96.8
|
92.1 Percentage of participants
Interval 82.4 to 97.4
|
93.8 Percentage of participants
Interval 79.2 to 99.2
|
97.3 Percentage of participants
Interval 85.8 to 99.9
|
100.0 Percentage of participants
Interval 59.0 to 100.0
|
100.0 Percentage of participants
Interval 94.0 to 100.0
|
—
|
—
|
—
|
—
|
100.0 Percentage of participants
Interval 63.1 to 100.0
|
SECONDARY outcome
Timeframe: Day 1 through the final data cutoff date (approximately 7 years 6 months)Population: Efficacy evaluable population included all enrolled participants who received 1 or more doses of study drug and had 1 or more response assessments after the first dose of study drug. The DoR was analyzed for participants who achieved OR.
The DoR is defined as the time from the date of achieving the first CR, CRi, or PR to the date of progressive disease (PD) or death due to any cause, whichever occurred first. The CR, CRi, or PR are defined in the above outcome measure. For CLL/SLL, PD is defined as lympho \>=50% increase from baseline with \>= 5000 B lymphocytes/µL, progressive cytopenias by bone marrow biopsy, appearance of any new lesion or new appearance of hepatomegaly or splenomegaly or \>= 50 % increase in lymphadenopathy/hepatomegaly/splenomegaly, platelets decrease of \>=50% from baseline secondary to CLL or \< 100,000/µL and worsening bone marrow or Hb decrease of \> 2 g/dL from baseline secondary to CLL or decrease to less than 100 g/L and worsening bone marrow. For RS, PD is defined as an increase by 25 % in longest diameter, new lesion or assessable disease progression. The DoR was estimated using Kaplan-Meier method.
Outcome measures
| Measure |
Cohort 4a
n=6 Participants
Participants with CLL received oral acalabrutinib Dose 4 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 4b
n=6 Participants
Participants with CLL received oral acalabrutinib Dose 5 BID (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 2a
n=6 Participants
Participants with CLL/SLL received oral acalabrutinib Dose 2 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 2b
n=58 Participants
Participants with CLL received oral acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 2c
n=30 Participants
Participants with CLL received oral acalabrutinib Dose 5 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 7
n=36 Participants
Treatment-naïve participants with CLL or SLL received oral acalabrutinib Dose 5 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 3
n=7 Participants
Participants with CLL received oral acalabrutinib Dose 3 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 8a
n=60 Participants
Participants with CLL or SLL and were not tolerating ibrutinib treatment, received oral acalabrutinib Dose 5 QD (which switched to Dose 1 BID per protocol amendment 4) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 8b
Participants with CLL or SLL and were not tolerating ibrutinib treatment, received oral acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 9
Participants with DLBCLRS or PLL transformation, received oral acalabrutinib Dose 5 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 10
Participants with CLL/SLL and had relapsed/refractory ibrutinib treatment, received oral acalabrutinib Dose 5 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 11
Treatment-naïve participants with CLL/SLL, received oral acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 1
n=8 Participants
Participants with CLL/SLL received oral acalabrutinib Dose 1 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Duration of Response (DOR) as Assessed by the Investigator
|
64.1 Months
Interval 19.4 to
Upper limit of 95% CI was not calculated because insufficient number of participants had DoR.
|
NA Months
Interval 38.9 to
Median and upper limit of 95% CI were not calculated because insufficient number of participants had DoR.
|
26.7 Months
Interval 13.9 to
Upper limit of 95% CI was not calculated because insufficient number of participants had DoR.
|
77.3 Months
Interval 46.3 to
Upper limit of 95% CI was not calculated because insufficient number of participants had DoR.
|
43.0 Months
Interval 29.4 to
Upper limit of 95% CI was not calculated because insufficient number of participants had DoR.
|
NA Months
Median and 95% CI were not calculated because insufficient number of participants had DoR.
|
NA Months
Interval 9.0 to
Median and upper limit of 95% CI were not calculated because insufficient number of participants had DoR.
|
NA Months
Median and 95% CI were not calculated because insufficient number of participants had DoR.
|
—
|
—
|
—
|
—
|
33.3 Months
Interval 13.8 to
Upper limit of 95% confidence interval (CI) was not calculated because insufficient number of participants had DoR.
|
SECONDARY outcome
Timeframe: Day 1 through the final data cutoff date (approximately 7 years 6 months)Population: Efficacy evaluable population included all enrolled participants who received 1 or more doses of study drug and had 1 or more response assessments after the first dose of study drug.
The PFS is defined as the time from the date of first dose of study drug to the date of first PD or death due to any cause, whichever occurred first. For CLL/SLL, PD is defined as lympho \>= 50 % increase from baseline with \>= 5000 B lymphocytes/µL, progressive cytopenias by bone marrow biopsy, appearance of any new lesion or new appearance of hepatomegaly or splenomegaly or \>= 50 % increase in lymphadenopathy/hepatomegaly/splenomegaly, platelets decrease of \>= 50 % from baseline secondary to CLL or \< 100,000/µL and worsening bone marrow or Hb decrease of \> 2 g/dL from baseline secondary to CLL or decrease to less than 100 g/L and worsening bone marrow. For RS, PD is defined as an increase by 25 % in longest diameter, new lesion or assessable disease progression. The PFS was estimated using Kaplan-Meier method.
Outcome measures
| Measure |
Cohort 4a
n=6 Participants
Participants with CLL received oral acalabrutinib Dose 4 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 4b
n=6 Participants
Participants with CLL received oral acalabrutinib Dose 5 BID (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 2a
n=8 Participants
Participants with CLL/SLL received oral acalabrutinib Dose 2 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 2b
n=65 Participants
Participants with CLL received oral acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 2c
n=33 Participants
Participants with CLL received oral acalabrutinib Dose 5 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 7
n=37 Participants
Treatment-naïve participants with CLL or SLL received oral acalabrutinib Dose 5 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 3
n=7 Participants
Participants with CLL received oral acalabrutinib Dose 3 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 8a
n=62 Participants
Participants with CLL or SLL and were not tolerating ibrutinib treatment, received oral acalabrutinib Dose 5 QD (which switched to Dose 1 BID per protocol amendment 4) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 8b
Participants with CLL or SLL and were not tolerating ibrutinib treatment, received oral acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 9
Participants with DLBCLRS or PLL transformation, received oral acalabrutinib Dose 5 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 10
Participants with CLL/SLL and had relapsed/refractory ibrutinib treatment, received oral acalabrutinib Dose 5 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 11
Treatment-naïve participants with CLL/SLL, received oral acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Cohort 1
n=9 Participants
Participants with CLL/SLL received oral acalabrutinib Dose 1 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Progression Free Survival (PFS) as Assessed by the Investigator
|
67.8 Months
Interval 33.2 to
Upper limit of 95% CI was not calculated because insufficient number of participants had PFS.
|
NA Months
Interval 40.7 to
Median and upper limit of 95% CI were not calculated because insufficient number of participants had PFS..
|
33.1 Months
Interval 15.8 to
Upper limit of 95% CI was not calculated because insufficient number of participants had PFS.
|
79.1 Months
Interval 49.8 to
Upper limit of 95% CI was not calculated because insufficient number of participants had PFS.
|
46.6 Months
Interval 33.9 to
Upper limit of 95% CI was not calculated because insufficient number of participants had PFS.
|
NA Months
Median and 95% CI were not calculated because insufficient number of participants had PFS..
|
NA Months
Interval 12.7 to
Median and upper limit of 95% CI were not calculated because insufficient number of participants had PFS..
|
NA Months
Median and 95% CI were not calculated because insufficient number of participants had PFS..
|
—
|
—
|
—
|
—
|
38.3 Months
Interval 15.5 to
Upper limit of 95% CI was not calculated because insufficient number of participants had PFS.
|
Adverse Events
Relapsed/Refractory Cohort
Serious events: 86 serious events
Other events: 134 other events
Deaths: 13 deaths
Treatment-naive Cohort
Serious events: 50 serious events
Other events: 99 other events
Deaths: 2 deaths
Ibrutinib-intolerant Cohort
Serious events: 20 serious events
Other events: 33 other events
Deaths: 2 deaths
Richters Syndrome/Prolymphocytic Leukemia Transformation Cohort
Serious events: 18 serious events
Other events: 28 other events
Deaths: 11 deaths
Ibrutinib Relapsed/Refractory Cohort
Serious events: 3 serious events
Other events: 6 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Relapsed/Refractory Cohort
n=134 participants at risk
Phase 1 (dose-escalation) and Phase 2 (dose-expansion) were conducted for participants with relapsed/refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). In Phase 1, participants received oral once daily (QD) acalabrutinib at Dose 1 (Cohort 1), Dose 2 (Cohort 2a), Dose 3 (Cohort 3), and Dose 4 (Cohort 4a), and twice daily (BID) acalabrutinib at Dose 1 (Cohort 2b) and Dose 5 (Cohort 4b) for 28 days (1 cycle). In Phase 2, participants received oral acalabrutinib at Dose 1 BID (Cohort 2b) or Dose 5 QD (Cohort 2c, later switched to Dose 1 BID per protocol amendment 6) until disease progression or until the investigator considered the study treatment to be intolerable or no longer in the participant's best interest. Participants from Phase 1 continued to receive Dose 1 BID until disease progression or until the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Treatment-naive Cohort
n=99 participants at risk
Treatment-naïve participants with confirmed CLL or SLL, received oral acalabrutinib Dose 5 QD (Cohort 7, later switched to Dose 1 BID per protocol amendment 6) or Dose 1 BID (Cohort 11) until disease progression or until the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Ibrutinib-intolerant Cohort
n=33 participants at risk
Participants with confirmed CLL or SLL and were not tolerating ibrutinib treatment, received oral acalabrutinib Dose 5 QD (Cohort 8a, later switched to Dose 1 BID per protocol amendment 4) or Dose 1 BID (Cohort 8b) until disease progression or until the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Richters Syndrome/Prolymphocytic Leukemia Transformation Cohort
n=29 participants at risk
Participants with diffuse large B-cell lymphoma (DLBCL) Richter's transformation (RS) or prolymphocytic leukemia transformation (PLL), received oral acalabrutinib Dose 5 BID (Cohort 9) until disease progression or until the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Ibrutinib Relapsed/Refractory Cohort
n=6 participants at risk
Participants with confirmed CLL/SLL and had relapsed/refractory to ibrutinib treatment, received oral acalabrutinib Dose 5 QD (Cohort 10) until disease progression or until the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Vascular disorders
Hypertension
|
1.5%
2/134 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Vascular disorders
Hypotension
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Vascular disorders
Malignant hypertension
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Vascular disorders
Phlebitis superficial
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Abdominal pain
|
2.2%
3/134 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
16.7%
1/6 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Colitis
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Diarrhoea
|
3.0%
4/134 • Number of events 5 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
16.7%
1/6 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Epiploic appendagitis
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Blood and lymphatic system disorders
Methaemoglobinaemia
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Large intestinal haemorrhage
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Blood and lymphatic system disorders
Splenic infarction
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Blood and lymphatic system disorders
Anaemia
|
3.0%
4/134 • Number of events 4 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.5%
2/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
1.5%
2/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Cardiac disorders
Acute coronary syndrome
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Tongue haematoma
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
General disorders
Asthenia
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
General disorders
Chest pain
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Cardiac disorders
Angina pectoris
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
General disorders
Fatigue
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
6.9%
2/29 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
General disorders
Infusion site injury
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
General disorders
Malaise
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
General disorders
Non-cardiac chest pain
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
General disorders
Pain
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
General disorders
Pyrexia
|
1.5%
2/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
6.1%
2/33 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Cardiac disorders
Atrial fibrillation
|
3.0%
4/134 • Number of events 6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Hepatobiliary disorders
Perforation bile duct
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Immune system disorders
Anaphylactic reaction
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Abscess limb
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Acute sinusitis
|
1.5%
2/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Appendicitis
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Blood and lymphatic system disorders
Autoimmune haemolytic anaemia
|
1.5%
2/134 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Cardiac disorders
Atrioventricular block complete
|
1.5%
2/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Aspergillus infection
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Brain abscess
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Bronchitis
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Bronchitis bacterial
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Covid-19
|
1.5%
2/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Groin abscess
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Cardiac disorders
Cardiac arrest
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Herpes simplex
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Herpes virus infection
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Infection
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
6.9%
2/29 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Influenza
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
3/99 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Kidney infection
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Klebsiella bacteraemia
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Lower respiratory tract infection
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Lymphangitis
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Covid-19 pneumonia
|
2.2%
3/134 • Number of events 4 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Campylobacter infection
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Candida sepsis
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Cellulitis
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
6.1%
2/33 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Cardiac disorders
Bradycardia
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Genital infection fungal
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Gingivitis
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Upper respiratory tract infection
|
1.5%
2/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
16.7%
1/6 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Urinary tract infection
|
2.2%
3/134 • Number of events 6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
6.1%
2/33 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Viral myocarditis
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Viral pharyngitis
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Viral sepsis
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Wound infection
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Cardiac disorders
Myocardial infarction
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Injury, poisoning and procedural complications
Fall
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Investigations
Cytomegalovirus test positive
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Investigations
Immunosuppressant drug level increased
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Investigations
Troponin i increased
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
3.0%
4/134 • Number of events 4 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
10.3%
3/29 • Number of events 5 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Cardiac disorders
Cardiac failure congestive
|
0.75%
1/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Pneumonia
|
14.2%
19/134 • Number of events 24 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
6.1%
6/99 • Number of events 8 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
9.1%
3/33 • Number of events 8 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Pneumonia fungal
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Pneumonia parainfluenzae viral
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Pneumonia streptococcal
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.2%
3/134 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
10.3%
3/29 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Pseudomonal sepsis
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Pseudomonas infection
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Pyelitis
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Respiratory tract infection
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Salmonellosis
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Sepsis
|
2.2%
3/134 • Number of events 6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
6.9%
2/29 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
16.7%
1/6 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Septic shock
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
16.7%
1/6 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Sinusitis
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Skin infection
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Nervous system disorders
Hemiparesis
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Nervous system disorders
Multiple system atrophy
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Nervous system disorders
Seizure
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Nervous system disorders
Syncope
|
2.2%
3/134 • Number of events 4 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Nervous system disorders
Transient ischaemic attack
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Psychiatric disorders
Delirium
|
1.5%
2/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Renal and urinary disorders
Acute kidney injury
|
3.7%
5/134 • Number of events 5 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
6.9%
2/29 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Renal and urinary disorders
Haematuria
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Renal and urinary disorders
Renal impairment
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Renal and urinary disorders
Subcapsular renal haematoma
|
0.75%
1/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Cytomegalovirus infection reactivation
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Escherichia sepsis
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Gastroenteritis
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Gastroenteritis rotavirus
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Genital abscess
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Mycobacterium avium complex infection
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Neutropenic sepsis
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Cardiac disorders
Cardiac tamponade
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Pelvic abscess
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Pharyngitis
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Injury, poisoning and procedural complications
Fracture
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Injury, poisoning and procedural complications
Hip fracture
|
1.5%
2/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Blood and lymphatic system disorders
Haemolysis
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Cardiac disorders
Ventricular fibrillation
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Musculoskeletal and connective tissue disorders
Vertebral column mass
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Angiosarcoma
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign lung neoplasm
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer recurrent
|
0.75%
1/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Central nervous system leukaemia
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myeloid leukaemia
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer metastatic
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma multiforme
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma stage 0
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine carcinoma of the skin
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary renal cell carcinoma
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasmablastic lymphoma
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
1.5%
2/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
4.0%
4/99 • Number of events 4 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour flare
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
16.7%
1/6 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Nervous system disorders
Amyotrophic lateral sclerosis
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Nervous system disorders
Cerebrovascular accident
|
0.75%
1/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Nervous system disorders
Dizziness
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Nervous system disorders
Encephalopathy
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.5%
2/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory alkalosis
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.5%
2/134 • Number of events 6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract haemorrhage
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Vascular disorders
Aortic stenosis
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Vascular disorders
Haematoma
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
Other adverse events
| Measure |
Relapsed/Refractory Cohort
n=134 participants at risk
Phase 1 (dose-escalation) and Phase 2 (dose-expansion) were conducted for participants with relapsed/refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). In Phase 1, participants received oral once daily (QD) acalabrutinib at Dose 1 (Cohort 1), Dose 2 (Cohort 2a), Dose 3 (Cohort 3), and Dose 4 (Cohort 4a), and twice daily (BID) acalabrutinib at Dose 1 (Cohort 2b) and Dose 5 (Cohort 4b) for 28 days (1 cycle). In Phase 2, participants received oral acalabrutinib at Dose 1 BID (Cohort 2b) or Dose 5 QD (Cohort 2c, later switched to Dose 1 BID per protocol amendment 6) until disease progression or until the investigator considered the study treatment to be intolerable or no longer in the participant's best interest. Participants from Phase 1 continued to receive Dose 1 BID until disease progression or until the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Treatment-naive Cohort
n=99 participants at risk
Treatment-naïve participants with confirmed CLL or SLL, received oral acalabrutinib Dose 5 QD (Cohort 7, later switched to Dose 1 BID per protocol amendment 6) or Dose 1 BID (Cohort 11) until disease progression or until the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Ibrutinib-intolerant Cohort
n=33 participants at risk
Participants with confirmed CLL or SLL and were not tolerating ibrutinib treatment, received oral acalabrutinib Dose 5 QD (Cohort 8a, later switched to Dose 1 BID per protocol amendment 4) or Dose 1 BID (Cohort 8b) until disease progression or until the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Richters Syndrome/Prolymphocytic Leukemia Transformation Cohort
n=29 participants at risk
Participants with diffuse large B-cell lymphoma (DLBCL) Richter's transformation (RS) or prolymphocytic leukemia transformation (PLL), received oral acalabrutinib Dose 5 BID (Cohort 9) until disease progression or until the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
Ibrutinib Relapsed/Refractory Cohort
n=6 participants at risk
Participants with confirmed CLL/SLL and had relapsed/refractory to ibrutinib treatment, received oral acalabrutinib Dose 5 QD (Cohort 10) until disease progression or until the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Eye disorders
Ocular hypertension
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Eye disorders
Photophobia
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Eye disorders
Photopsia
|
1.5%
2/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Eye disorders
Posterior capsule opacification
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Eye disorders
Retinal artery occlusion
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Eye disorders
Retinal detachment
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
3/99 • Number of events 4 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Eye disorders
Retinal tear
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Eye disorders
Scleral haemorrhage
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Eye disorders
Strabismus
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Eye disorders
Vision blurred
|
3.7%
5/134 • Number of events 6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
9.1%
9/99 • Number of events 9 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Eye disorders
Visual acuity reduced
|
1.5%
2/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Eye disorders
Visual impairment
|
1.5%
2/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Blood and lymphatic system disorders
Lymph node pain
|
5.2%
7/134 • Number of events 7 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
6.1%
6/99 • Number of events 6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
9.1%
3/33 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Eye disorders
Vitreous degeneration
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Eye disorders
Vitreous floaters
|
1.5%
2/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Eye disorders
Vitreous haemorrhage
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Abdominal discomfort
|
3.0%
4/134 • Number of events 4 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
5.1%
5/99 • Number of events 5 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Abdominal distension
|
8.2%
11/134 • Number of events 12 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
8.1%
8/99 • Number of events 8 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
9.1%
3/33 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
6.9%
2/29 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
16.7%
1/6 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Abdominal hernia
|
1.5%
2/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Abdominal pain
|
11.9%
16/134 • Number of events 24 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
10.1%
10/99 • Number of events 17 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
9.1%
3/33 • Number of events 4 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
16.7%
1/6 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
3/99 • Number of events 4 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.2%
11/134 • Number of events 12 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
6.1%
6/99 • Number of events 6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Anal fissure haemorrhage
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Anal pruritus
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Anorectal discomfort
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Aphthous ulcer
|
2.2%
3/134 • Number of events 4 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
3/99 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Barrett's oesophagus
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Breath odour
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Coeliac disease
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
3.0%
4/134 • Number of events 4 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Constipation
|
26.1%
35/134 • Number of events 41 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
20.2%
20/99 • Number of events 22 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
21.2%
7/33 • Number of events 9 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
6.9%
2/29 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
16.7%
1/6 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Dental caries
|
8.2%
11/134 • Number of events 13 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
5.1%
5/99 • Number of events 6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
6.1%
2/33 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Diarrhoea
|
53.0%
71/134 • Number of events 131 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
53.5%
53/99 • Number of events 93 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
60.6%
20/33 • Number of events 31 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
48.3%
14/29 • Number of events 19 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Dry mouth
|
3.0%
4/134 • Number of events 4 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
6.1%
6/99 • Number of events 6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Dumping syndrome
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Dyspepsia
|
10.4%
14/134 • Number of events 14 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
10.1%
10/99 • Number of events 11 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
18.2%
6/33 • Number of events 6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Dysphagia
|
6.7%
9/134 • Number of events 9 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Enterocolitis
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Eosinophilic oesophagitis
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Flatulence
|
5.2%
7/134 • Number of events 7 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
3/99 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Gastritis
|
1.5%
2/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
4.0%
4/99 • Number of events 4 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
2.2%
3/134 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Gastrointestinal ulcer
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
9.0%
12/134 • Number of events 12 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
17.2%
17/99 • Number of events 20 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
6.1%
2/33 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Gingival blister
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Gingival discolouration
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Gingival disorder
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Haematochezia
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
3/99 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Haemorrhoids
|
1.5%
2/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
4.0%
4/99 • Number of events 4 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Hiatus hernia
|
1.5%
2/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
3/99 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Hyperaesthesia teeth
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Ileus
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
3/99 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Blood and lymphatic system disorders
Neutropenia
|
15.7%
21/134 • Number of events 42 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
8.1%
8/99 • Number of events 14 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
12.1%
4/33 • Number of events 8 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
24.1%
7/29 • Number of events 9 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
16.7%
1/6 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Large intestinal ulcer
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Large intestine polyp
|
2.2%
3/134 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
5.1%
5/99 • Number of events 5 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Lip blister
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
16.7%
1/6 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Lip erythema
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Lip pain
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Lip swelling
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Lip ulceration
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Melaena
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
2.2%
3/134 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Mouth ulceration
|
1.5%
2/134 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Nausea
|
35.1%
47/134 • Number of events 67 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
34.3%
34/99 • Number of events 53 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
33.3%
11/33 • Number of events 16 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
13.8%
4/29 • Number of events 4 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
33.3%
2/6 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Odynophagia
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Oesophageal obstruction
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Oesophageal pain
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Oesophageal spasm
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Oesophagitis
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Oesophagitis ulcerative
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Blood and lymphatic system disorders
Anaemia
|
13.4%
18/134 • Number of events 27 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
9.1%
9/99 • Number of events 12 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
12.1%
4/33 • Number of events 7 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
31.0%
9/29 • Number of events 13 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
16.7%
1/6 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Blood and lymphatic system disorders
Spontaneous haemorrhage
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Oral blood blister
|
3.7%
5/134 • Number of events 5 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Oral disorder
|
2.2%
3/134 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Oral mucosa haematoma
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Oral mucosal blistering
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Oral pain
|
3.7%
5/134 • Number of events 5 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
4.0%
4/99 • Number of events 4 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Peritoneal haematoma
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Pharyngo-oesophageal diverticulum
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Proctalgia
|
1.5%
2/134 • Number of events 4 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.7%
5/134 • Number of events 17 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
9.1%
3/33 • Number of events 5 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Pseudopolyposis
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Rectal discharge
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
2.2%
3/134 • Number of events 4 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
6.1%
6/99 • Number of events 6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Rectal polyp
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Rectal prolapse
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Retching
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Salivary gland enlargement
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Spigelian hernia
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Stomatitis
|
9.7%
13/134 • Number of events 16 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
14.1%
14/99 • Number of events 23 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
15.2%
5/33 • Number of events 6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Swollen tongue
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Tongue geographic
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Tongue haematoma
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Tongue ulceration
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Toothache
|
4.5%
6/134 • Number of events 8 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
7.1%
7/99 • Number of events 8 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Umbilical hernia
|
2.2%
3/134 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
4.0%
4/99 • Number of events 4 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Vomiting
|
24.6%
33/134 • Number of events 44 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
24.2%
24/99 • Number of events 30 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
27.3%
9/33 • Number of events 12 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
10.3%
3/29 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
16.7%
1/6 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
General disorders
Asthenia
|
4.5%
6/134 • Number of events 7 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
6.9%
2/29 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
General disorders
Axillary pain
|
1.5%
2/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
General disorders
Catheter site haemorrhage
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
General disorders
Chest discomfort
|
3.0%
4/134 • Number of events 5 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
3/99 • Number of events 4 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
16.7%
1/6 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
General disorders
Chest pain
|
2.2%
3/134 • Number of events 4 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
16.7%
1/6 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
General disorders
Chills
|
11.9%
16/134 • Number of events 18 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
13.1%
13/99 • Number of events 14 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
9.1%
3/33 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
6.9%
2/29 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
16.7%
1/6 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
General disorders
Complication associated with device
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
General disorders
Crepitations
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
General disorders
Cyst
|
1.5%
2/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
3/99 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
General disorders
Early satiety
|
1.5%
2/134 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
General disorders
Face oedema
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
General disorders
Facial pain
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
4.0%
4/99 • Number of events 4 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
9.1%
3/33 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Cardiac disorders
Angina pectoris
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
General disorders
Fat necrosis
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
General disorders
Fatigue
|
36.6%
49/134 • Number of events 58 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
22.2%
22/99 • Number of events 31 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
21.2%
7/33 • Number of events 10 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
20.7%
6/29 • Number of events 8 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
16.7%
1/6 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
General disorders
Feeling cold
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
General disorders
Feeling hot
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
General disorders
Gait disturbance
|
2.2%
3/134 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
3/99 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
General disorders
General physical health deterioration
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
General disorders
Granuloma
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
General disorders
Hernia
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
General disorders
Hyperpyrexia
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
General disorders
Hypothermia
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Cardiac disorders
Aortic valve disease
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
General disorders
Influenza like illness
|
9.0%
12/134 • Number of events 14 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
13.1%
13/99 • Number of events 14 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
6.1%
2/33 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
General disorders
Infusion site rash
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
General disorders
Injection site bruising
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
6.9%
2/29 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
General disorders
Injection site phlebitis
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
General disorders
Injection site reaction
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
General disorders
Injection site swelling
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
General disorders
Localised oedema
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
General disorders
Malaise
|
4.5%
6/134 • Number of events 7 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
4.0%
4/99 • Number of events 5 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
6.1%
2/33 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
General disorders
Mass
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Cardiac disorders
Aortic valve incompetence
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
General disorders
Medical device site bruise
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
General disorders
Mucosal inflammation
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
General disorders
Nodule
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
General disorders
Non-cardiac chest pain
|
6.0%
8/134 • Number of events 11 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
12.1%
12/99 • Number of events 16 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
24.2%
8/33 • Number of events 8 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
10.3%
3/29 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
General disorders
Oedema
|
1.5%
2/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
General disorders
Oedema peripheral
|
20.9%
28/134 • Number of events 36 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
18.2%
18/99 • Number of events 25 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
21.2%
7/33 • Number of events 7 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
6.9%
2/29 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
General disorders
Pain
|
2.2%
3/134 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
General disorders
Peripheral swelling
|
3.0%
4/134 • Number of events 4 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
General disorders
Physical deconditioning
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
General disorders
Polyp
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
General disorders
Pyrexia
|
29.1%
39/134 • Number of events 69 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
13.1%
13/99 • Number of events 19 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
30.3%
10/33 • Number of events 17 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
20.7%
6/29 • Number of events 12 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
General disorders
Suprapubic pain
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
General disorders
Swelling
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
General disorders
Swelling face
|
2.2%
3/134 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
General disorders
Systemic inflammatory response syndrome
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
General disorders
Vaccination site mass
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
General disorders
Vaccination site pain
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Hepatobiliary disorders
Cholecystitis
|
0.75%
1/134 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Cardiac disorders
Atrial fibrillation
|
7.5%
10/134 • Number of events 11 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
5.1%
5/99 • Number of events 8 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
6.1%
2/33 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
10.3%
3/29 • Number of events 6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.5%
2/134 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Hepatobiliary disorders
Hepatic mass
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Immune system disorders
Allergy to arthropod bite
|
5.2%
7/134 • Number of events 7 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
4.0%
4/99 • Number of events 4 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Immune system disorders
Allergy to arthropod sting
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Immune system disorders
Contrast media allergy
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Immune system disorders
Drug hypersensitivity
|
2.2%
3/134 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
4.0%
4/99 • Number of events 4 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Gastrointestinal disorders
Gastric polyps
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Conjunctivitis
|
5.2%
7/134 • Number of events 7 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
5.1%
5/99 • Number of events 5 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Cystitis
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Diverticulitis
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
3/99 • Number of events 4 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Ear infection
|
5.2%
7/134 • Number of events 8 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
3/99 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Encephalitis
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Epididymitis
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Cardiac disorders
Bundle branch block left
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Fungal skin infection
|
1.5%
2/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Furuncle
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Gastroenteritis
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
6.1%
2/33 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Cardiac disorders
Bundle branch block right
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Gastroenteritis viral
|
3.7%
5/134 • Number of events 5 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Helicobacter infection
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Hepatic infection
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Herpes zoster
|
4.5%
6/134 • Number of events 7 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
6.1%
2/33 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
16.7%
1/6 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Infected bite
|
0.75%
1/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Infected dermal cyst
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Influenza
|
9.0%
12/134 • Number of events 13 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
6.1%
6/99 • Number of events 6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Intervertebral discitis
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Cardiac disorders
Cardiac failure
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Laryngitis
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Localised infection
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Lower respiratory tract infection
|
6.7%
9/134 • Number of events 12 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
9.1%
3/33 • Number of events 5 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Lyme disease
|
0.75%
1/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Lymphangitis
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Mastoiditis
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Metapneumovirus infection
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Moraxella infection
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Mycobacterial infection
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Myringitis
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Nail infection
|
2.2%
3/134 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Nasopharyngitis
|
8.2%
11/134 • Number of events 12 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
9.1%
9/99 • Number of events 11 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
9.1%
3/33 • Number of events 6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Oral candidiasis
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
6.9%
2/29 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Oral herpes
|
3.7%
5/134 • Number of events 5 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
9.1%
3/33 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Oropharyngeal candidiasis
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Otitis externa
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
3/99 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
9.1%
3/33 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Otitis media
|
4.5%
6/134 • Number of events 6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Paronychia
|
1.5%
2/134 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Parotitis
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Pelvic abscess
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Perirectal abscess
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Pharyngitis
|
2.2%
3/134 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
3/99 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Pharyngitis streptococcal
|
1.5%
2/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Pneumonia
|
19.4%
26/134 • Number of events 29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
12.1%
12/99 • Number of events 16 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
9.1%
3/33 • Number of events 9 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
10.3%
3/29 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
16.7%
1/6 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Pneumonia bacterial
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Pneumonia cryptococcal
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Pneumonia pseudomonal
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Pneumonia streptococcal
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Post-acute covid-19 syndrome
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Propionibacterium infection
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.2%
3/134 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Immune system disorders
Food allergy
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Cardiac disorders
Atrial flutter
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Immune system disorders
Graft versus host disease in gastrointestinal tract
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Acute sinusitis
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Appendicitis
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Aspergillus infection
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Bacteraemia
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Bacteriuria
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Body tinea
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Breast abscess
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Bronchitis
|
10.4%
14/134 • Number of events 18 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
14.1%
14/99 • Number of events 16 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
18.2%
6/33 • Number of events 9 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
6.9%
2/29 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Burkholderia cepacia complex infection
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Chronic sinusitis
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
10.3%
3/29 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Cardiac disorders
Bradycardia
|
3.7%
5/134 • Number of events 8 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Clostridium difficile infection
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Coccidioidomycosis
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Tracheitis
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Upper respiratory tract infection
|
40.3%
54/134 • Number of events 88 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
49.5%
49/99 • Number of events 85 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
45.5%
15/33 • Number of events 25 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
10.3%
3/29 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
16.7%
1/6 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Ureteritis
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Urinary tract infection
|
11.2%
15/134 • Number of events 32 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
13.1%
13/99 • Number of events 24 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
15.2%
5/33 • Number of events 11 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
6.9%
2/29 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Cardiac disorders
Mitral valve disease
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Wound infection
|
1.5%
2/134 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Injury, poisoning and procedural complications
Face injury
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Cardiac disorders
Sinus bradycardia
|
3.7%
5/134 • Number of events 6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Injury, poisoning and procedural complications
Human bite
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Cardiac disorders
Sinus tachycardia
|
3.7%
5/134 • Number of events 6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
10.1%
10/99 • Number of events 11 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
16.7%
1/6 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Injury, poisoning and procedural complications
Limb injury
|
3.0%
4/134 • Number of events 4 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
4.0%
4/99 • Number of events 5 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
1.5%
2/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Injury, poisoning and procedural complications
Muscle strain
|
3.7%
5/134 • Number of events 5 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
5.1%
5/99 • Number of events 5 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Injury, poisoning and procedural complications
Scar
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Injury, poisoning and procedural complications
Scratch
|
1.5%
2/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Blood and lymphatic system disorders
Haemolysis
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Cardiac disorders
Tachycardia
|
2.2%
3/134 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
8.1%
8/99 • Number of events 9 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
6.1%
2/33 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
10.3%
3/29 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Injury, poisoning and procedural complications
Stoma site reaction
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
3.0%
4/134 • Number of events 4 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
6.1%
2/33 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Investigations
Antinuclear antibody positive
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Investigations
Aspartate aminotransferase increased
|
3.0%
4/134 • Number of events 4 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Investigations
Bk polyomavirus test positive
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Investigations
Blood albumin decreased
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Investigations
Blood beta-d-glucan increased
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Investigations
Blood bilirubin increased
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Investigations
Blood cholesterol increased
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Investigations
Blood creatinine increased
|
5.2%
7/134 • Number of events 9 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
16.7%
1/6 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Investigations
Blood folate decreased
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Investigations
Blood immunoglobulin g decreased
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
6.1%
2/33 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Investigations
Blood potassium decreased
|
1.5%
2/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Investigations
Blood pressure increased
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Investigations
Blood sodium decreased
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Investigations
Blood testosterone decreased
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Investigations
Bone density decreased
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Investigations
Breath sounds abnormal
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Investigations
C-reactive protein increased
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Cardiac disorders
Ventricular tachycardia
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Investigations
Cardiac murmur
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
5.1%
5/99 • Number of events 5 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Investigations
Coagulation time prolonged
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Investigations
Computerised tomogram thorax abnormal
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Investigations
Eastern cooperative oncology group performance status worsened
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Investigations
Electrocardiogram qt prolonged
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Investigations
Haemoglobin decreased
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Investigations
Influenza a virus test positive
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Investigations
Influenza b virus test positive
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Investigations
Neutrophil count decreased
|
0.75%
1/134 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
10.3%
3/29 • Number of events 6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Investigations
Neutrophil count increased
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Investigations
Norovirus test positive
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
16.7%
1/6 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Prostatic abscess
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Pseudomonas infection
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Rash pustular
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
16.7%
1/6 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Respiratory tract infection
|
1.5%
2/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Rhinitis
|
3.0%
4/134 • Number of events 4 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
6.9%
2/29 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
16.7%
1/6 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Salmonellosis
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Scrotal infection
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Cardiac disorders
Extrasystoles
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Sepsis
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Sinusitis
|
24.6%
33/134 • Number of events 44 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
22.2%
22/99 • Number of events 34 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
9.1%
3/33 • Number of events 6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
6.9%
2/29 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
16.7%
1/6 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Sinusitis bacterial
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Skin bacterial infection
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Skin infection
|
1.5%
2/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
9.1%
3/33 • Number of events 4 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Staphylococcal infection
|
2.2%
3/134 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Subcutaneous abscess
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Testicular abscess
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Tinea cruris
|
1.5%
2/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Cardiac disorders
Left ventricular failure
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Tinea infection
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Tinea versicolour
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Tooth infection
|
2.2%
3/134 • Number of events 4 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
6.1%
6/99 • Number of events 6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
6.1%
2/33 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Investigations
Troponin i increased
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Investigations
Troponin increased
|
0.75%
1/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Investigations
Weight decreased
|
20.1%
27/134 • Number of events 43 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
8.1%
8/99 • Number of events 13 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
9.1%
3/33 • Number of events 5 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
13.8%
4/29 • Number of events 6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Investigations
Weight increased
|
25.4%
34/134 • Number of events 97 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
33.3%
33/99 • Number of events 105 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
30.3%
10/33 • Number of events 22 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Investigations
White blood cell count decreased
|
0.75%
1/134 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
16.4%
22/134 • Number of events 26 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
13.1%
13/99 • Number of events 19 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
6.1%
2/33 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
13.8%
4/29 • Number of events 4 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Metabolism and nutrition disorders
Dehydration
|
3.0%
4/134 • Number of events 5 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
7.1%
7/99 • Number of events 7 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
6.1%
2/33 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
10.3%
3/29 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Congenital, familial and genetic disorders
Porokeratosis
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Metabolism and nutrition disorders
Fluid overload
|
1.5%
2/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
2.2%
3/134 • Number of events 6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
3.0%
4/134 • Number of events 4 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
3/99 • Number of events 4 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Metabolism and nutrition disorders
Hyperphagia
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
3.0%
4/134 • Number of events 4 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
6.1%
6/99 • Number of events 6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Ear and labyrinth disorders
Deafness
|
1.5%
2/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.75%
1/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
6.1%
2/33 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.2%
7/134 • Number of events 8 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
4.0%
4/99 • Number of events 4 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
13.8%
4/29 • Number of events 5 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
16.7%
1/6 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
1.5%
2/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
6.9%
2/29 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.5%
2/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
3.0%
4/134 • Number of events 5 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
4.0%
4/99 • Number of events 4 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Metabolism and nutrition disorders
Polydipsia
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
1.5%
2/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Metabolism and nutrition disorders
Vitamin b complex deficiency
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Metabolism and nutrition disorders
Vitamin b12 deficiency
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Metabolism and nutrition disorders
Vitamin d deficiency
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
35.1%
47/134 • Number of events 78 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
55.6%
55/99 • Number of events 83 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
27.3%
9/33 • Number of events 13 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
20.7%
6/29 • Number of events 8 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
5.2%
7/134 • Number of events 8 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
10.1%
10/99 • Number of events 10 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
6.1%
2/33 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.2%
19/134 • Number of events 21 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
22.2%
22/99 • Number of events 26 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
9.1%
3/33 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
13.8%
4/29 • Number of events 5 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Investigations
Platelet count decreased
|
3.0%
4/134 • Number of events 7 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 8 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
13.8%
4/29 • Number of events 4 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Investigations
Prostatic specific antigen increased
|
0.75%
1/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Congenital, familial and genetic disorders
Laryngocele
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Investigations
Thyroid hormones increased
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Investigations
Transaminases increased
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
3.0%
4/134 • Number of events 4 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
9.1%
3/33 • Number of events 4 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
6.9%
2/29 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Musculoskeletal and connective tissue disorders
Bursa disorder
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
1.5%
2/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Ear and labyrinth disorders
Ear congestion
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
2.2%
3/134 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Musculoskeletal and connective tissue disorders
Limb mass
|
3.0%
4/134 • Number of events 4 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Musculoskeletal and connective tissue disorders
Medial tibial stress syndrome
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Musculoskeletal and connective tissue disorders
Muscle atrophy
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
16.7%
1/6 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
8.2%
11/134 • Number of events 14 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
14.1%
14/99 • Number of events 20 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
9.1%
3/33 • Number of events 4 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
3.0%
4/134 • Number of events 6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
7.1%
7/99 • Number of events 7 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
1.5%
2/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
6.1%
2/33 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Ear and labyrinth disorders
Ear haemorrhage
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal deformity
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
2.2%
3/134 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.5%
2/134 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
1.5%
2/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
1.5%
2/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Ear and labyrinth disorders
Ear pain
|
3.7%
5/134 • Number of events 5 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
6.1%
6/99 • Number of events 6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
6.1%
2/33 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
3.7%
5/134 • Number of events 5 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
3/99 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
17.9%
24/134 • Number of events 32 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
11.1%
11/99 • Number of events 14 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
15.2%
5/33 • Number of events 7 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
13.8%
4/29 • Number of events 4 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
16.7%
1/6 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
1.5%
2/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
1.5%
2/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Ear and labyrinth disorders
External ear pain
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
1.5%
2/134 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
1.5%
2/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
3/99 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spine
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nasal neoplasm
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Ear and labyrinth disorders
Hypoacusis
|
2.2%
3/134 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
6.1%
6/99 • Number of events 6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sebaceous adenoma
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
4.5%
6/134 • Number of events 6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
5.1%
5/99 • Number of events 5 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sinonasal papilloma
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin neoplasm bleeding
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Nervous system disorders
Carotid arteriosclerosis
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Nervous system disorders
Carotid artery aneurysm
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Ear and labyrinth disorders
Motion sickness
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Nervous system disorders
Carpal tunnel syndrome
|
3.7%
5/134 • Number of events 6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Nervous system disorders
Cerebral microhaemorrhage
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Nervous system disorders
Cerebrovascular accident
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Nervous system disorders
Cervical radiculopathy
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Nervous system disorders
Cognitive disorder
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Nervous system disorders
Dementia alzheimer's type
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Nervous system disorders
Disturbance in attention
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Nervous system disorders
Dizziness
|
17.9%
24/134 • Number of events 27 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
20.2%
20/99 • Number of events 22 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
18.2%
6/33 • Number of events 7 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
13.8%
4/29 • Number of events 6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
16.7%
1/6 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Ear and labyrinth disorders
Tinnitus
|
3.0%
4/134 • Number of events 4 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
9.1%
3/33 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Nervous system disorders
Dizziness postural
|
2.2%
3/134 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Nervous system disorders
Dysgeusia
|
3.0%
4/134 • Number of events 4 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Nervous system disorders
Facial paralysis
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Nervous system disorders
Headache
|
50.7%
68/134 • Number of events 98 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
48.5%
48/99 • Number of events 79 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
42.4%
14/33 • Number of events 18 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
41.4%
12/29 • Number of events 16 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
16.7%
1/6 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Nervous system disorders
Hemianopia
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Nervous system disorders
Hemiparesis
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Nervous system disorders
Hypersomnia
|
1.5%
2/134 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Ear and labyrinth disorders
Tympanic membrane perforation
|
1.5%
2/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Nervous system disorders
Hypoaesthesia
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
3/99 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Nervous system disorders
Hypogeusia
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Nervous system disorders
Idiopathic partial epilepsy
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Nervous system disorders
Intracranial pressure increased
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Nervous system disorders
Lethargy
|
1.5%
2/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Nervous system disorders
Memory impairment
|
3.7%
5/134 • Number of events 6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
5.1%
5/99 • Number of events 6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
6.1%
2/33 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Nervous system disorders
Mental impairment
|
1.5%
2/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Nervous system disorders
Migraine
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Nervous system disorders
Neuralgia
|
2.2%
3/134 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Ear and labyrinth disorders
Vertigo
|
6.0%
8/134 • Number of events 9 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
4.0%
4/99 • Number of events 4 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
15.2%
5/33 • Number of events 6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Nervous system disorders
Neuropathy peripheral
|
3.0%
4/134 • Number of events 4 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Nervous system disorders
Nystagmus
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Nervous system disorders
Paraesthesia
|
14.2%
19/134 • Number of events 19 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
14.1%
14/99 • Number of events 15 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
15.2%
5/33 • Number of events 5 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Nervous system disorders
Parosmia
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
3.0%
4/134 • Number of events 5 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
5.1%
5/99 • Number of events 5 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
6.1%
2/33 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
6.9%
2/29 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Nervous system disorders
Post herpetic neuralgia
|
1.5%
2/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Nervous system disorders
Presyncope
|
4.5%
6/134 • Number of events 7 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
4.0%
4/99 • Number of events 4 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Nervous system disorders
Radiculopathy
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Nervous system disorders
Resting tremor
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Ear and labyrinth disorders
Vertigo positional
|
1.5%
2/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Nervous system disorders
Restless legs syndrome
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Nervous system disorders
Retinal migraine
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Nervous system disorders
Sciatica
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
6.1%
6/99 • Number of events 7 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Nervous system disorders
Seizure
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Nervous system disorders
Sinus headache
|
2.2%
3/134 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Nervous system disorders
Somnolence
|
1.5%
2/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Nervous system disorders
Spinal cord disorder
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Nervous system disorders
Syncope
|
4.5%
6/134 • Number of events 6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
7.1%
7/99 • Number of events 9 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
6.1%
2/33 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Nervous system disorders
Taste disorder
|
1.5%
2/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Nervous system disorders
Tremor
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Product Issues
Device dislocation
|
0.75%
1/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Psychiatric disorders
Affect lability
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Psychiatric disorders
Anger
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Psychiatric disorders
Anxiety
|
10.4%
14/134 • Number of events 15 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
9.1%
9/99 • Number of events 12 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
6.1%
2/33 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Psychiatric disorders
Confusional state
|
1.5%
2/134 • Number of events 4 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
3/99 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
6.9%
2/29 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Psychiatric disorders
Depressed mood
|
1.5%
2/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Endocrine disorders
Goitre
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Psychiatric disorders
Depression
|
7.5%
10/134 • Number of events 10 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
5.1%
5/99 • Number of events 5 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
6.9%
2/29 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Psychiatric disorders
Emotional distress
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Psychiatric disorders
Homicidal ideation
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Psychiatric disorders
Insomnia
|
13.4%
18/134 • Number of events 20 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
19.2%
19/99 • Number of events 20 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
15.2%
5/33 • Number of events 5 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
13.8%
4/29 • Number of events 4 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Psychiatric disorders
Libido decreased
|
2.2%
3/134 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Psychiatric disorders
Mental status changes
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Psychiatric disorders
Phonophobia
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Psychiatric disorders
Premature ejaculation
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Psychiatric disorders
Sleep disorder
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Endocrine disorders
Hypothyroidism
|
2.2%
3/134 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Psychiatric disorders
Stress
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Renal and urinary disorders
Acute kidney injury
|
5.2%
7/134 • Number of events 9 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
33.3%
2/6 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Renal and urinary disorders
Bladder hypertrophy
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Renal and urinary disorders
Chronic kidney disease
|
2.2%
3/134 • Number of events 6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Renal and urinary disorders
Dysuria
|
4.5%
6/134 • Number of events 8 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Renal and urinary disorders
Haematuria
|
5.2%
7/134 • Number of events 8 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
10.1%
10/99 • Number of events 13 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
9.1%
3/33 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Renal and urinary disorders
Lower urinary tract symptoms
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Renal and urinary disorders
Micturition urgency
|
4.5%
6/134 • Number of events 6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
6.1%
2/33 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Renal and urinary disorders
Nephrolithiasis
|
5.2%
7/134 • Number of events 9 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
3/99 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Endocrine disorders
Thyroid calcification
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Renal and urinary disorders
Nocturia
|
6.7%
9/134 • Number of events 9 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
5.1%
5/99 • Number of events 5 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Renal and urinary disorders
Pollakiuria
|
13.4%
18/134 • Number of events 20 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
8.1%
8/99 • Number of events 8 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
9.1%
3/33 • Number of events 4 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Renal and urinary disorders
Renal colic
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Renal and urinary disorders
Renal failure
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Renal and urinary disorders
Renal impairment
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Renal and urinary disorders
Renal mass
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Renal and urinary disorders
Renal pain
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Renal and urinary disorders
Subcapsular renal haematoma
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Renal and urinary disorders
Urge incontinence
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Endocrine disorders
Thyroid disorder
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Renal and urinary disorders
Urinary hesitation
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Renal and urinary disorders
Urinary incontinence
|
3.7%
5/134 • Number of events 5 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
4.0%
4/99 • Number of events 4 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Renal and urinary disorders
Urinary retention
|
3.0%
4/134 • Number of events 4 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
4.0%
4/99 • Number of events 4 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Renal and urinary disorders
Urinary tract pain
|
1.5%
2/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
3.0%
4/134 • Number of events 4 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
3/99 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Reproductive system and breast disorders
Breast mass
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
3.7%
5/134 • Number of events 6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
3/99 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Reproductive system and breast disorders
Genital haemorrhage
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Endocrine disorders
Thyroid mass
|
1.5%
2/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Reproductive system and breast disorders
Gynaecomastia
|
1.5%
2/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Reproductive system and breast disorders
Haematospermia
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Reproductive system and breast disorders
Oedema genital
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Reproductive system and breast disorders
Penile oedema
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Reproductive system and breast disorders
Peyronie's disease
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Reproductive system and breast disorders
Prostatic obstruction
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Reproductive system and breast disorders
Prostatitis
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Eye disorders
Cataract
|
5.2%
7/134 • Number of events 9 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
6.1%
6/99 • Number of events 7 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Reproductive system and breast disorders
Scrotal haemorrhage
|
1.5%
2/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Reproductive system and breast disorders
Testicular cyst
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Reproductive system and breast disorders
Testicular mass
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
1.5%
2/134 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Acquired diaphragmatic eventration
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Eye disorders
Cataract nuclear
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Asthma exercise induced
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.5%
2/134 • Number of events 6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
6.9%
2/29 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
14.9%
20/134 • Number of events 28 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
8.1%
8/99 • Number of events 9 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
9.1%
3/33 • Number of events 5 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
6.9%
2/29 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinalgia
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
9.7%
13/134 • Number of events 15 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
14.1%
14/99 • Number of events 14 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
11.9%
16/134 • Number of events 17 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
9.1%
9/99 • Number of events 10 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Eye disorders
Dry eye
|
3.7%
5/134 • Number of events 5 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
5.1%
5/99 • Number of events 5 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
4.5%
6/134 • Number of events 7 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
6.1%
6/99 • Number of events 6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
3/99 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillolith
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Blood and lymphatic system disorders
Jaundice acholuric
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Eye disorders
Episcleritis
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
11.9%
16/134 • Number of events 16 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
11.1%
11/99 • Number of events 16 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
15.2%
5/33 • Number of events 5 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord polyp
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Skin and subcutaneous tissue disorders
Brachioradial pruritus
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Eye disorders
Eye disorder
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
2.2%
3/134 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
2.2%
3/134 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
4.0%
4/99 • Number of events 4 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
3.7%
5/134 • Number of events 5 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
5.1%
5/99 • Number of events 5 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
6.1%
2/33 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
12.7%
17/134 • Number of events 18 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
16.2%
16/99 • Number of events 17 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
15.2%
5/33 • Number of events 5 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
16.7%
1/6 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Skin and subcutaneous tissue disorders
Eczema
|
3.7%
5/134 • Number of events 5 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
5.1%
5/99 • Number of events 5 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
9.1%
3/33 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Skin and subcutaneous tissue disorders
Eczema nummular
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
20.9%
28/134 • Number of events 34 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
18.2%
18/99 • Number of events 24 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
9.1%
3/33 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
6.9%
2/29 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Skin and subcutaneous tissue disorders
Pruritus allergic
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
1.5%
2/134 • Number of events 4 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Skin and subcutaneous tissue disorders
Purpura senile
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
3/99 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Skin and subcutaneous tissue disorders
Rash
|
15.7%
21/134 • Number of events 23 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
18.2%
18/99 • Number of events 23 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
18.2%
6/33 • Number of events 6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
6.9%
2/29 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
16.7%
1/6 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
4.5%
6/134 • Number of events 6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
4.0%
4/99 • Number of events 5 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
2.2%
3/134 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
12.7%
17/134 • Number of events 18 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
12.1%
12/99 • Number of events 13 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
9.1%
3/33 • Number of events 4 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Eye disorders
Eye pruritus
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
1.5%
2/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
3/99 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Skin and subcutaneous tissue disorders
Rash vesicular
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
1.5%
2/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
3/99 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Skin and subcutaneous tissue disorders
Scab
|
3.0%
4/134 • Number of events 4 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Skin and subcutaneous tissue disorders
Skin fragility
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Skin and subcutaneous tissue disorders
Skin haemorrhage
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
1.5%
2/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
3/99 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Eye disorders
Eye swelling
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
13.4%
18/134 • Number of events 22 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
5.1%
5/99 • Number of events 5 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
15.2%
5/33 • Number of events 5 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
1.5%
2/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
3/99 • Number of events 5 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
9.1%
3/33 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Skin and subcutaneous tissue disorders
Skin plaque
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Skin and subcutaneous tissue disorders
Solar lentigo
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Skin and subcutaneous tissue disorders
Stasis dermatitis
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Skin and subcutaneous tissue disorders
Transient acantholytic dermatosis
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
3.0%
4/134 • Number of events 6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
3/99 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
16.7%
1/6 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Social circumstances
Excessive exercise
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Vascular disorders
Aortic aneurysm
|
1.5%
2/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Eye disorders
Eyelid pain
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Vascular disorders
Arterial thrombosis
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
16.7%
1/6 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Vascular disorders
Brachiocephalic vein thrombosis
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Vascular disorders
Capillary disorder
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Vascular disorders
Capillary leak syndrome
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Vascular disorders
Deep vein thrombosis
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Vascular disorders
Essential hypertension
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Vascular disorders
Extravasation blood
|
1.5%
2/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Vascular disorders
Flushing
|
2.2%
3/134 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Vascular disorders
Haematoma
|
4.5%
6/134 • Number of events 6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
5.1%
5/99 • Number of events 6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Skin and subcutaneous tissue disorders
Erythema
|
9.0%
12/134 • Number of events 12 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
3/99 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Skin and subcutaneous tissue disorders
Erythema annulare
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Skin and subcutaneous tissue disorders
Erythema nodosum
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Skin and subcutaneous tissue disorders
Follicular mucinosis
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Eye disorders
Eye inflammation
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Skin and subcutaneous tissue disorders
Granulomatous dermatitis
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Skin and subcutaneous tissue disorders
Hair texture abnormal
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Skin and subcutaneous tissue disorders
Hand dermatitis
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
9.0%
12/134 • Number of events 14 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
11.1%
11/99 • Number of events 14 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
6.1%
2/33 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
6.9%
2/29 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Skin and subcutaneous tissue disorders
Hypertrichosis
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Skin and subcutaneous tissue disorders
Ingrown hair
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Skin and subcutaneous tissue disorders
Keratosis pilaris
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Skin and subcutaneous tissue disorders
Lichenoid keratosis
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Skin and subcutaneous tissue disorders
Macule
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Eye disorders
Eye irritation
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Skin and subcutaneous tissue disorders
Madarosis
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Skin and subcutaneous tissue disorders
Nail bed bleeding
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Skin and subcutaneous tissue disorders
Nail bed inflammation
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
2.2%
3/134 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Skin and subcutaneous tissue disorders
Panniculitis
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Eye disorders
Ocular hyperaemia
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Vascular disorders
Hypertensive crisis
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Vascular disorders
Hypotension
|
5.2%
7/134 • Number of events 7 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
11.1%
11/99 • Number of events 11 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
15.2%
5/33 • Number of events 6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
33.3%
2/6 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Vascular disorders
Lymphoedema
|
0.75%
1/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
5.1%
5/99 • Number of events 7 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Vascular disorders
Peripheral coldness
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Eye disorders
Eyelid thickening
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Vascular disorders
Plethoric face
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Vascular disorders
Poor peripheral circulation
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Vascular disorders
Varicose vein
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Vascular disorders
Vasculitis
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Eye disorders
Lacrimation increased
|
1.5%
2/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Eye disorders
Macular degeneration
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
3/99 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Eye disorders
Metamorphopsia
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Eye disorders
Night blindness
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Vascular disorders
Hot flush
|
3.7%
5/134 • Number of events 6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
5.1%
5/99 • Number of events 6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Vascular disorders
Hypertension
|
21.6%
29/134 • Number of events 39 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
28.3%
28/99 • Number of events 60 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
18.2%
6/33 • Number of events 8 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Eye disorders
Eyelid ptosis
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Immune system disorders
Graft versus host disease in skin
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Immune system disorders
Hypersensitivity
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Immune system disorders
Hypogammaglobulinaemia
|
2.2%
3/134 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Immune system disorders
Immunodeficiency
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Immune system disorders
Seasonal allergy
|
1.5%
2/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Abscess
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Covid-19
|
3.0%
4/134 • Number of events 5 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Campylobacter infection
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Candida infection
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Cellulitis
|
9.0%
12/134 • Number of events 13 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
9.1%
3/33 • Number of events 7 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Epstein-barr virus infection reactivation
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Escherichia bacteraemia
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
External ear cellulitis
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Eye infection
|
3.0%
4/134 • Number of events 5 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Folliculitis
|
1.5%
2/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Fungal infection
|
0.75%
1/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Gastrointestinal bacterial infection
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Genital infection fungal
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Gingivitis
|
1.5%
2/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Groin abscess
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Haemophilus infection
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Urinary tract infection enterococcal
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Vaginal infection
|
1.5%
2/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Vascular device infection
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Viral pharyngitis
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Viral upper respiratory tract infection
|
2.2%
3/134 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Injury, poisoning and procedural complications
Animal bite
|
3.7%
5/134 • Number of events 5 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
7.5%
10/134 • Number of events 10 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
8.1%
8/99 • Number of events 13 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Injury, poisoning and procedural complications
Axillary web syndrome
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Injury, poisoning and procedural complications
Bone contusion
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Injury, poisoning and procedural complications
Cartilage injury
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Injury, poisoning and procedural complications
Contusion
|
31.3%
42/134 • Number of events 60 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
50.5%
50/99 • Number of events 62 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
33.3%
11/33 • Number of events 13 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
17.2%
5/29 • Number of events 6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Cardiac disorders
Palpitations
|
9.7%
13/134 • Number of events 15 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
4.0%
4/99 • Number of events 4 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Injury, poisoning and procedural complications
Dental restoration failure
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Injury, poisoning and procedural complications
Eye contusion
|
1.5%
2/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Injury, poisoning and procedural complications
Fall
|
15.7%
21/134 • Number of events 41 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
23.2%
23/99 • Number of events 34 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
18.2%
6/33 • Number of events 11 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
13.8%
4/29 • Number of events 4 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
16.7%
1/6 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Injury, poisoning and procedural complications
Foreign body in eye
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Injury, poisoning and procedural complications
Fracture
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Injury, poisoning and procedural complications
Fractured coccyx
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
6.1%
2/33 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Injury, poisoning and procedural complications
Joint injury
|
2.2%
3/134 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Injury, poisoning and procedural complications
Ligament injury
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
2.2%
3/134 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
4.0%
4/99 • Number of events 4 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Injury, poisoning and procedural complications
Musculoskeletal injury
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Injury, poisoning and procedural complications
Nail injury
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Injury, poisoning and procedural complications
Periorbital haemorrhage
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Injury, poisoning and procedural complications
Post procedural contusion
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
1.5%
2/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Injury, poisoning and procedural complications
Post procedural inflammation
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Injury, poisoning and procedural complications
Post procedural swelling
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Injury, poisoning and procedural complications
Procedural pain
|
1.5%
2/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
3/99 • Number of events 5 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Injury, poisoning and procedural complications
Radiation pneumonitis
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Injury, poisoning and procedural complications
Radiation proctitis
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Injury, poisoning and procedural complications
Reactive gastropathy
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Injury, poisoning and procedural complications
Respiratory fume inhalation disorder
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Injury, poisoning and procedural complications
Rib fracture
|
3.0%
4/134 • Number of events 4 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
3/99 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Injury, poisoning and procedural complications
Scrotal haematoma
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
1.5%
2/134 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
3/99 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Injury, poisoning and procedural complications
Skin laceration
|
4.5%
6/134 • Number of events 7 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
5.1%
5/99 • Number of events 5 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Injury, poisoning and procedural complications
Skin wound
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
2.2%
3/134 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Injury, poisoning and procedural complications
Stomal hernia
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
3/99 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Cardiac disorders
Tricuspid valve disease
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
4.5%
6/134 • Number of events 9 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
8.1%
8/99 • Number of events 12 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Injury, poisoning and procedural complications
Venous injury
|
0.75%
1/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Injury, poisoning and procedural complications
Wound
|
2.2%
3/134 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Injury, poisoning and procedural complications
Wound haemorrhage
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Investigations
Alanine aminotransferase increased
|
2.2%
3/134 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 4 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
6.9%
2/29 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Investigations
Amylase increased
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Cardiac disorders
Ventricular extrasystoles
|
2.2%
3/134 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Congenital, familial and genetic disorders
Hypertrophic cardiomyopathy
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Investigations
Influenza virus test positive
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Investigations
International normalised ratio increased
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 4 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Investigations
Lipase increased
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Investigations
Lymphocyte count decreased
|
0.75%
1/134 • Number of events 4 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Investigations
Lymphocyte count increased
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Musculoskeletal and connective tissue disorders
Chondrocalcinosis pyrophosphate
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Musculoskeletal and connective tissue disorders
Dupuytren's contracture
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
2.2%
3/134 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
6.1%
6/99 • Number of events 6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
3.7%
5/134 • Number of events 5 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
3/99 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
1.5%
2/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
1.5%
2/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Ear and labyrinth disorders
Ear discomfort
|
2.2%
3/134 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Musculoskeletal and connective tissue disorders
Joint hyperextension
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
1.5%
2/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
13.4%
18/134 • Number of events 22 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
14.1%
14/99 • Number of events 17 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
24.2%
8/33 • Number of events 10 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
10.3%
3/29 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
16.7%
1/6 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
3.7%
5/134 • Number of events 5 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
4.0%
4/99 • Number of events 4 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
16.7%
1/6 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Musculoskeletal and connective tissue disorders
Sinus tarsi syndrome
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.75%
1/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Ear and labyrinth disorders
Ear pruritus
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Musculoskeletal and connective tissue disorders
Tendon pain
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
4.0%
4/99 • Number of events 4 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
1.5%
2/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Musculoskeletal and connective tissue disorders
Vertebral column mass
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Ear and labyrinth disorders
Eustachian tube disorder
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
8.2%
11/134 • Number of events 12 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
11.1%
11/99 • Number of events 17 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
12.1%
4/33 • Number of events 4 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basosquamous carcinoma of skin
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of urethra
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer recurrent
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Ear and labyrinth disorders
Eustachian tube dysfunction
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear cell renal cell carcinoma
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Dysplastic naevus
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Eye naevus
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroma
|
0.75%
1/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibrous histiocytoma
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Ear and labyrinth disorders
External ear inflammation
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of skin
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large intestine benign neoplasm
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia cutis
|
0.75%
1/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip neoplasm
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip squamous cell carcinoma
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
1.5%
2/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm skin
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Ear and labyrinth disorders
Hyperacusis
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian neoplasm
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic neoplasm
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Paraneoplastic syndrome
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
1.5%
2/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
2.2%
3/134 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Blood and lymphatic system disorders
Increased tendency to bruise
|
11.2%
15/134 • Number of events 15 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
10.1%
10/99 • Number of events 10 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
9.1%
3/33 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
3.0%
4/134 • Number of events 4 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
1.5%
2/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
4.0%
4/99 • Number of events 5 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
6.0%
8/134 • Number of events 9 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
7.1%
7/99 • Number of events 7 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm benign
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Ear and labyrinth disorders
Middle ear effusion
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Nervous system disorders
Amnesia
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Nervous system disorders
Aphasia
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Nervous system disorders
Balance disorder
|
1.5%
2/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Catarrh
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.75%
1/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
35.1%
47/134 • Number of events 63 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
32.3%
32/99 • Number of events 41 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
39.4%
13/33 • Number of events 19 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
13.8%
4/29 • Number of events 12 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
16.7%
1/6 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
3.7%
5/134 • Number of events 7 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
4.0%
4/99 • Number of events 4 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
20.1%
27/134 • Number of events 36 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
17.2%
17/99 • Number of events 18 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
18.2%
6/33 • Number of events 6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
10.3%
3/29 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
33.3%
2/6 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
3.7%
5/134 • Number of events 5 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
5.1%
5/99 • Number of events 5 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
16.7%
1/6 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Eye disorders
Chorioretinopathy
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
11.9%
16/134 • Number of events 25 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
12.1%
12/99 • Number of events 19 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
12.1%
4/33 • Number of events 7 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
10.3%
3/29 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal haemorrhage
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Eye disorders
Conjunctival haemorrhage
|
3.0%
4/134 • Number of events 4 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Lung opacity
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
14.9%
20/134 • Number of events 30 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
28.3%
28/99 • Number of events 30 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
18.2%
6/33 • Number of events 7 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
17.2%
23/134 • Number of events 26 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
17.2%
17/99 • Number of events 22 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
12.1%
4/33 • Number of events 4 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnoea
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal disorder
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.2%
3/134 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
4.0%
4/99 • Number of events 6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
17.2%
5/29 • Number of events 6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Eye disorders
Conjunctival hyperaemia
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
1.5%
2/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
3.0%
4/134 • Number of events 4 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
6.1%
6/99 • Number of events 6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
1.5%
2/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary pain
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Reflux laryngitis
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Eye disorders
Dacryostenosis acquired
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory acidosis
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory symptom
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
3/99 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
2.2%
3/134 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
5.2%
7/134 • Number of events 7 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
5.1%
5/99 • Number of events 5 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
1.5%
2/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
3/99 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Sputum increased
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
1.5%
2/134 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
3/99 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
7.5%
10/134 • Number of events 11 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
5.1%
5/99 • Number of events 5 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
6.1%
2/33 • Number of events 4 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.0%
8/134 • Number of events 9 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
8.1%
8/99 • Number of events 8 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Skin and subcutaneous tissue disorders
Blood blister
|
2.2%
3/134 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative generalised
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Skin and subcutaneous tissue disorders
Dermatitis psoriasiform
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Eye disorders
Eye haemorrhage
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Skin and subcutaneous tissue disorders
Dermatosis
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
9.1%
3/33 • Number of events 4 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
9.7%
13/134 • Number of events 14 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
6.1%
6/99 • Number of events 7 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
18.2%
6/33 • Number of events 7 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
16.7%
1/6 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Skin and subcutaneous tissue disorders
Necrobiosis lipoidica diabeticorum
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Skin and subcutaneous tissue disorders
Neurodermatitis
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
15.7%
21/134 • Number of events 24 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
15.2%
15/99 • Number of events 19 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
6.1%
2/33 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
6.9%
2/29 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Eye disorders
Eye movement disorder
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Skin and subcutaneous tissue disorders
Nodular rash
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/99 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
6.1%
2/33 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.4%
1/29 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Skin and subcutaneous tissue disorders
Pigmentation disorder
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Skin and subcutaneous tissue disorders
Pityriasis rosea
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Skin and subcutaneous tissue disorders
Poikiloderma
|
0.00%
0/134 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
1.0%
1/99 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Eye disorders
Eye pain
|
0.75%
1/134 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
2.0%
2/99 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/33 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Skin and subcutaneous tissue disorders
Precancerous skin lesion
|
2.2%
3/134 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
3/99 • Number of events 4 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
3.0%
1/33 • Number of events 1 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/29 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.0%
12/134 • Number of events 15 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
8.1%
8/99 • Number of events 10 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
6.1%
2/33 • Number of events 2 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
6.9%
2/29 • Number of events 3 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
0.00%
0/6 • Day 1 through the final data cutoff date (approximately 7 years 6 months)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
- Publication restrictions are in place
Restriction type: OTHER