Trial Outcomes & Findings for Acalabrutinib Safety Study in Untreated and Relapsed or Refractory Chronic Lymphocytic Leukemia Patients (NCT NCT04008706)
NCT ID: NCT04008706
Last Updated: 2026-09-01
Results Overview
The safety and tolerability of acalabrutinib monotherapy were evaluated in participants with treatment-naïve or relapsed/refractory chronic lymphocytic leukemia. Treatment-emergent AEs (TEAEs) were defined as AEs that started after first dose of acalabrutinib or which started prior to first dose of acalabrutinib but worsened following first dose of acalabrutinib, and where the start date of worsening was also no later than 30 days after the date of last dose of acalabrutinib or the first date starting new anticancer therapy, whichever was earlier. Adverse events of special interest (AESI) were defined as ventricular arrhythmias. Events of clinical interest (ECI) were defined as cardiac events, hepatotoxicity, hypertension, infections, interstitial lung disease/pneumonitis, hemorrhage (major hemorrhage), cytopenias (anemia, leukopenia, thrombocytopenia), second primary malignancies, and tumor lysis syndrome. Common Terminology Criteria for Adverse Events = CTCAE
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
552 participants
Primary outcome timeframe
Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Results posted on
2026-09-01
Participant Flow
The study was conducted from 17 September 2019 (first participant enrolled) to 04 November 2025 (last participant last visit) at 108 study centers across 17 countries.
Participants who met the inclusion criteria and none of the exclusion criteria were enrolled to the study. All study assessments were performed as per the schedule of assessments.
Participant milestones
| Measure |
Acalabrutinib Treatment-naïve (TN) Cohort
Participants with treatment-naïve chronic lymphocytic leukemia received 100 mg acalabrutinib capsules twice daily.
|
Acalabrutinib Relapsed/Refractory (R/R) Cohort
Participants with relapsed/refractory chronic lymphocytic leukemia received 100 mg acalabrutinib capsules twice daily.
|
Acalabrutinib Prior Bruton Tyrosine Kinase Inhibitor (BTKi) Therapy Cohort
Participants with prior ibrutinib (BTKi) therapy received 100 mg acalabrutinib capsules twice daily.
|
|---|---|---|---|
|
Overall Study
STARTED
|
310
|
202
|
40
|
|
Overall Study
COMPLETED
|
199
|
106
|
15
|
|
Overall Study
NOT COMPLETED
|
111
|
96
|
25
|
Reasons for withdrawal
| Measure |
Acalabrutinib Treatment-naïve (TN) Cohort
Participants with treatment-naïve chronic lymphocytic leukemia received 100 mg acalabrutinib capsules twice daily.
|
Acalabrutinib Relapsed/Refractory (R/R) Cohort
Participants with relapsed/refractory chronic lymphocytic leukemia received 100 mg acalabrutinib capsules twice daily.
|
Acalabrutinib Prior Bruton Tyrosine Kinase Inhibitor (BTKi) Therapy Cohort
Participants with prior ibrutinib (BTKi) therapy received 100 mg acalabrutinib capsules twice daily.
|
|---|---|---|---|
|
Overall Study
Participant Decision
|
15
|
4
|
3
|
|
Overall Study
Adverse Event
|
55
|
59
|
9
|
|
Overall Study
Condition under investigation worsened
|
14
|
26
|
9
|
|
Overall Study
Development of study specific discontinuation criteria
|
2
|
1
|
1
|
|
Overall Study
Investigator Decision
|
8
|
0
|
0
|
|
Overall Study
Death
|
2
|
2
|
0
|
|
Overall Study
Consent withdrawal
|
3
|
1
|
0
|
|
Overall Study
Other
|
12
|
2
|
3
|
|
Overall Study
Missing
|
0
|
1
|
0
|
Baseline Characteristics
Acalabrutinib Safety Study in Untreated and Relapsed or Refractory Chronic Lymphocytic Leukemia Patients
Baseline characteristics by cohort
| Measure |
Acalabrutinib TN Cohort
n=310 Participants
Participants with treatment-naïve chronic lymphocytic leukemia received 100 mg acalabrutinib capsules twice daily.
|
Acalabrutinib R/R Cohort
n=202 Participants
Participants with relapsed/refractory chronic lymphocytic leukemia received 100 mg acalabrutinib capsules twice daily.
|
Acalabrutinib Prior BTKi Therapy Cohort
n=40 Participants
Participants with prior ibrutinib (BTKi) therapy received 100 mg acalabrutinib capsules twice daily.
|
Total
n=552 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
69.6 Years
STANDARD_DEVIATION 9.47 • n=14 Participants
|
67.2 Years
STANDARD_DEVIATION 9.99 • n=36 Participants
|
68.2 Years
STANDARD_DEVIATION 12.11 • n=324 Participants
|
68.6 Years
STANDARD_DEVIATION 9.92 • n=49 Participants
|
|
Sex: Female, Male
Female
|
112 Participants
n=14 Participants
|
81 Participants
n=36 Participants
|
22 Participants
n=324 Participants
|
215 Participants
n=49 Participants
|
|
Sex: Female, Male
Male
|
198 Participants
n=14 Participants
|
121 Participants
n=36 Participants
|
18 Participants
n=324 Participants
|
337 Participants
n=49 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
22 Participants
n=14 Participants
|
28 Participants
n=36 Participants
|
6 Participants
n=324 Participants
|
56 Participants
n=49 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
249 Participants
n=14 Participants
|
159 Participants
n=36 Participants
|
30 Participants
n=324 Participants
|
438 Participants
n=49 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
39 Participants
n=14 Participants
|
15 Participants
n=36 Participants
|
4 Participants
n=324 Participants
|
58 Participants
n=49 Participants
|
PRIMARY outcome
Timeframe: Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)Population: Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
The safety and tolerability of acalabrutinib monotherapy were evaluated in participants with treatment-naïve or relapsed/refractory chronic lymphocytic leukemia. Treatment-emergent AEs (TEAEs) were defined as AEs that started after first dose of acalabrutinib or which started prior to first dose of acalabrutinib but worsened following first dose of acalabrutinib, and where the start date of worsening was also no later than 30 days after the date of last dose of acalabrutinib or the first date starting new anticancer therapy, whichever was earlier. Adverse events of special interest (AESI) were defined as ventricular arrhythmias. Events of clinical interest (ECI) were defined as cardiac events, hepatotoxicity, hypertension, infections, interstitial lung disease/pneumonitis, hemorrhage (major hemorrhage), cytopenias (anemia, leukopenia, thrombocytopenia), second primary malignancies, and tumor lysis syndrome. Common Terminology Criteria for Adverse Events = CTCAE
Outcome measures
| Measure |
Acalabrutinib TN Cohort
n=310 Participants
Participants with treatment-naïve chronic lymphocytic leukemia received 100 mg acalabrutinib capsules twice daily.
|
Acalabrutinib R/R Cohort
n=202 Participants
Participants with relapsed/refractory chronic lymphocytic leukemia received 100 mg acalabrutinib capsules twice daily.
|
Acalabrutinib Prior BTKi Therapy Cohort
n=40 Participants
Participants with prior ibrutinib (BTKi) therapy received 100 mg acalabrutinib capsules twice daily.
|
|---|---|---|---|
|
Number of Participants With Adverse Events (AEs)
Any TEAE
|
306 Participants
|
200 Participants
|
40 Participants
|
|
Number of Participants With Adverse Events (AEs)
Any TEAE, possibly related to acalabrutinib
|
253 Participants
|
149 Participants
|
38 Participants
|
|
Number of Participants With Adverse Events (AEs)
Any TEAE with CTCAE Grade 3 or higher
|
193 Participants
|
140 Participants
|
22 Participants
|
|
Number of Participants With Adverse Events (AEs)
Any TEAE with CTCAE Grade 3 or higher, possibly related to acalabrutinib
|
85 Participants
|
59 Participants
|
11 Participants
|
|
Number of Participants With Adverse Events (AEs)
Any Serious TEAE
|
152 Participants
|
118 Participants
|
12 Participants
|
|
Number of Participants With Adverse Events (AEs)
Any Serious TEAE, possibly related to acalabrutinib
|
41 Participants
|
31 Participants
|
3 Participants
|
|
Number of Participants With Adverse Events (AEs)
Any TEAE with outcome death
|
26 Participants
|
36 Participants
|
5 Participants
|
|
Number of Participants With Adverse Events (AEs)
Any TEAE with outcome death, possibly related to acalabrutinib
|
3 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events (AEs)
Any TEAE leading to discontinuation of acalabrutinib
|
59 Participants
|
64 Participants
|
11 Participants
|
|
Number of Participants With Adverse Events (AEs)
Any TEAE leading to discontinuation of acalabrutinib, possibly related to acalabrutinib
|
23 Participants
|
15 Participants
|
5 Participants
|
|
Number of Participants With Adverse Events (AEs)
Any AESI
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events (AEs)
Any ECI
|
284 Participants
|
192 Participants
|
38 Participants
|
SECONDARY outcome
Timeframe: 1 year after initial dose of study interventionPopulation: Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
The investigator-assessed OR was evaluated in participants receiving acalabrutinib monotherapy. OR was defined as a participant's best OR to the treatment and the overall response rate (ORR) has been reported for the proportion of participants who were considered responders. A participant was considered a responder if s(he) achieved complete response (CR), complete response with incomplete marrow recovery (CRi), or partial response (PR), according to the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 criteria.
Outcome measures
| Measure |
Acalabrutinib TN Cohort
n=310 Participants
Participants with treatment-naïve chronic lymphocytic leukemia received 100 mg acalabrutinib capsules twice daily.
|
Acalabrutinib R/R Cohort
n=202 Participants
Participants with relapsed/refractory chronic lymphocytic leukemia received 100 mg acalabrutinib capsules twice daily.
|
Acalabrutinib Prior BTKi Therapy Cohort
n=40 Participants
Participants with prior ibrutinib (BTKi) therapy received 100 mg acalabrutinib capsules twice daily.
|
|---|---|---|---|
|
Overall Response (OR)
|
82.3 Percentage of participants
Interval 77.54 to 86.35
|
75.7 Percentage of participants
Interval 69.23 to 81.48
|
55.0 Percentage of participants
Interval 38.49 to 70.74
|
SECONDARY outcome
Timeframe: The time from the first objective response to the time of documented disease progression or death due to any cause, whichever occurred first within the time period to complete up to 48 cycles of treatment (each cycle was 28 days) (approximately 74 months)Population: Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
The investigator-assessed DOR was evaluated in participants receiving acalabrutinib monotherapy. DOR was defined as the time from the first OR of CR, CRi, or PR to the time of documented disease progression or death due to any cause, whichever occurred first.
Outcome measures
| Measure |
Acalabrutinib TN Cohort
n=310 Participants
Participants with treatment-naïve chronic lymphocytic leukemia received 100 mg acalabrutinib capsules twice daily.
|
Acalabrutinib R/R Cohort
n=202 Participants
Participants with relapsed/refractory chronic lymphocytic leukemia received 100 mg acalabrutinib capsules twice daily.
|
Acalabrutinib Prior BTKi Therapy Cohort
n=40 Participants
Participants with prior ibrutinib (BTKi) therapy received 100 mg acalabrutinib capsules twice daily.
|
|---|---|---|---|
|
Duration of Response (DOR)
|
NA Months
The median DOR and 95% confidence interval were not estimable because fewer than 50% of participants had a DOR event at the time of analysis, hence median DOR was never reached due to insufficient number of participants with events.
|
47.2 Months
Interval 46.0 to 51.0
|
33.3 Months
Interval 23.2 to
Although the median DOR was estimable, the upper limit of the 95% confidence interval for median DOR was not estimable as there was increased uncertainty due to a small sample size and an insufficient number of DOR events.
|
SECONDARY outcome
Timeframe: From the start of study intervention to completion of 48 cycles (each cycle was 28 days) or the earlier of the first documentation of disease progression or death from any cause (approximately 74 months)Population: Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
The investigator-assessed PFS was evaluated in participants receiving acalabrutinib monotherapy. PFS was defined as the interval from the start of study intervention to the earlier of the first documentation of disease progression or death from any cause.
Outcome measures
| Measure |
Acalabrutinib TN Cohort
n=310 Participants
Participants with treatment-naïve chronic lymphocytic leukemia received 100 mg acalabrutinib capsules twice daily.
|
Acalabrutinib R/R Cohort
n=202 Participants
Participants with relapsed/refractory chronic lymphocytic leukemia received 100 mg acalabrutinib capsules twice daily.
|
Acalabrutinib Prior BTKi Therapy Cohort
n=40 Participants
Participants with prior ibrutinib (BTKi) therapy received 100 mg acalabrutinib capsules twice daily.
|
|---|---|---|---|
|
Progression-free Survival (PFS)
|
NA Months
The median PFS and 95% confidence interval were not estimable because fewer than 50% of participants had a PFS event at the time of analysis, hence median PFS was never reached due to insufficient number of participants with events.
|
57.3 Months
Interval 51.71 to 60.42
|
44.4 Months
Interval 29.67 to
Although the median PFS was estimable, the upper limit of the 95% confidence interval for median PFS was not estimable as there was increased uncertainty due to a small sample size and an insufficient number of PFS events.
|
Adverse Events
Acalabrutinib TN Cohort
Serious events: 152 serious events
Other events: 294 other events
Deaths: 29 deaths
Acalabrutinib R/R Cohort
Serious events: 118 serious events
Other events: 180 other events
Deaths: 42 deaths
Acalabrutinib Prior BTKi Therapy Cohort
Serious events: 12 serious events
Other events: 39 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Acalabrutinib TN Cohort
n=310 participants at risk
Participants with treatment-naïve chronic lymphocytic leukemia received 100 mg acalabrutinib capsules twice daily.
|
Acalabrutinib R/R Cohort
n=202 participants at risk
Participants with relapsed/refractory chronic lymphocytic leukemia received 100 mg acalabrutinib capsules twice daily.
|
Acalabrutinib Prior BTKi Therapy Cohort
n=40 participants at risk
Participants with prior ibrutinib (BTKi) therapy received 100 mg acalabrutinib capsules twice daily.
|
|---|---|---|---|
|
Immune system disorders
Hypogammaglobulinaemia
|
0.00%
0/310 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/310 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Psychiatric disorders
Suicide attempt
|
0.32%
1/310 • Number of events 2 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Eye disorders
Cataract
|
0.00%
0/310 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.99%
2/202 • Number of events 2 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Eye disorders
Macular degeneration
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Eye disorders
Retinal artery occlusion
|
0.00%
0/310 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Ear and labyrinth disorders
Vertigo
|
0.65%
2/310 • Number of events 2 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Skin and subcutaneous tissue disorders
Subcutaneous emphysema
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Product Issues
Device issue
|
0.00%
0/310 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Product Issues
Product contamination microbial
|
0.00%
0/310 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/310 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/310 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Infections and infestations
Appendicitis
|
0.97%
3/310 • Number of events 3 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
2.0%
4/202 • Number of events 4 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Infections and infestations
Bronchitis
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Infections and infestations
COVID-19
|
11.0%
34/310 • Number of events 35 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
17.8%
36/202 • Number of events 37 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
2.5%
1/40 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Infections and infestations
COVID-19 pneumonia
|
2.9%
9/310 • Number of events 9 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
9.9%
20/202 • Number of events 21 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Infections and infestations
Cellulitis
|
1.3%
4/310 • Number of events 5 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Infections and infestations
Cholangitis infective
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Infections and infestations
Clostridium difficile infection
|
0.32%
1/310 • Number of events 2 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Infections and infestations
Cystitis
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Infections and infestations
Diverticulitis
|
0.32%
1/310 • Number of events 2 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Infections and infestations
Emphysematous cystitis
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Infections and infestations
Encephalitis
|
0.00%
0/310 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Infections and infestations
Endocarditis
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Infections and infestations
Enterococcal infection
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Infections and infestations
Enterovirus infection
|
0.00%
0/310 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Infections and infestations
Erysipelas
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 2 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Infections and infestations
Eye infection toxoplasmal
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Infections and infestations
Furuncle
|
0.00%
0/310 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Infections and infestations
Gastroenteritis
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Infections and infestations
Haemophilus infection
|
0.00%
0/310 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Infections and infestations
Hepatitis B reactivation
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Infections and infestations
Herpes zoster
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Infections and infestations
Herpes zoster meningoencephalitis
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Infections and infestations
Infection
|
0.32%
1/310 • Number of events 6 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Infections and infestations
Infective exacerbation of asthma
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Infections and infestations
Influenza
|
0.00%
0/310 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.99%
2/202 • Number of events 2 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Infections and infestations
Kidney infection
|
0.00%
0/310 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Infections and infestations
Large intestine infection
|
0.00%
0/310 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/310 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Infections and infestations
Oesophageal candidiasis
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Infections and infestations
Otitis media bacterial
|
0.00%
0/310 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.00%
0/310 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Infections and infestations
Pneumonia
|
5.8%
18/310 • Number of events 22 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
10.9%
22/202 • Number of events 32 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
12.5%
5/40 • Number of events 7 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/310 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.99%
2/202 • Number of events 2 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Infections and infestations
Pneumonia bacterial
|
0.97%
3/310 • Number of events 3 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.99%
2/202 • Number of events 2 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Infections and infestations
Pneumonia fungal
|
0.00%
0/310 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.00%
0/310 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Infections and infestations
Post-acute COVID-19 syndrome
|
0.00%
0/310 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
2.5%
1/40 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Infections and infestations
Pulmonary sepsis
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Infections and infestations
Pyelonephritis
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 2 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Infections and infestations
Respiratory tract infection
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
1.5%
3/202 • Number of events 3 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/310 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
2.5%
1/40 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/310 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Infections and infestations
Sepsis
|
1.9%
6/310 • Number of events 6 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.99%
2/202 • Number of events 2 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Infections and infestations
Septic shock
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Infections and infestations
Sinusitis
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.99%
2/202 • Number of events 2 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Infections and infestations
Sinusitis bacterial
|
0.00%
0/310 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Infections and infestations
Staphylococcal infection
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Infections and infestations
Streptococcal infection
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Infections and infestations
Tonsillitis
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Infections and infestations
Urinary tract infection
|
1.9%
6/310 • Number of events 6 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.99%
2/202 • Number of events 3 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Infections and infestations
Urosepsis
|
0.65%
2/310 • Number of events 3 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Infections and infestations
Wound infection
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/310 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.00%
0/310 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/310 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.99%
2/202 • Number of events 2 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/310 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.99%
2/202 • Number of events 2 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal adenoma
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ductal adenocarcinoma of pancreas
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma multiforme
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive lobular breast carcinoma
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.97%
3/310 • Number of events 3 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.65%
2/310 • Number of events 3 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
1.3%
4/310 • Number of events 4 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.99%
2/202 • Number of events 2 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic squamous cell carcinoma
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.65%
2/310 • Number of events 2 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nasal neoplasm
|
0.00%
0/310 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary renal cell carcinoma
|
0.00%
0/310 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.65%
2/310 • Number of events 2 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Richter's syndrome
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
2.5%
1/40 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the parotid gland
|
0.00%
0/310 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Blood and lymphatic system disorders
Agranulocytosis
|
0.00%
0/310 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.3%
4/310 • Number of events 4 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
2.5%
1/40 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
2.0%
4/202 • Number of events 4 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Blood and lymphatic system disorders
Heparin-induced thrombocytopenia
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Blood and lymphatic system disorders
Hyperviscosity syndrome
|
0.32%
1/310 • Number of events 2 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/310 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Blood and lymphatic system disorders
Splenic haemorrhage
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Blood and lymphatic system disorders
Splenic vein thrombosis
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.00%
0/310 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/310 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 2 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.65%
2/310 • Number of events 2 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.65%
2/310 • Number of events 2 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.97%
3/310 • Number of events 5 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.00%
0/310 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
2.5%
1/40 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Nervous system disorders
Aphasia
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Nervous system disorders
Dizziness
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/310 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Nervous system disorders
Headache
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Nervous system disorders
Hydrocephalus
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Nervous system disorders
Intracranial haematoma
|
0.00%
0/310 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
2.5%
1/40 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/310 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.99%
2/202 • Number of events 2 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Nervous system disorders
Petit mal epilepsy
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/310 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Nervous system disorders
Seizure
|
0.00%
0/310 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Nervous system disorders
Spinal cord infarction
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/310 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Nervous system disorders
Syncope
|
0.65%
2/310 • Number of events 2 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Nervous system disorders
Vestibular migraine
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/310 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.99%
2/202 • Number of events 2 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
2.5%
1/40 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Cardiac disorders
Acute left ventricular failure
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.65%
2/310 • Number of events 3 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Cardiac disorders
Angina pectoris
|
0.32%
1/310 • Number of events 2 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/310 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.99%
2/202 • Number of events 2 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Cardiac disorders
Atrial fibrillation
|
1.6%
5/310 • Number of events 7 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 2 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Cardiac disorders
Atrial flutter
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Cardiac disorders
Cardiac arrest
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Cardiac disorders
Cardiac failure
|
1.3%
4/310 • Number of events 8 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.99%
2/202 • Number of events 2 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.32%
1/310 • Number of events 3 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Cardiac disorders
Cor pulmonale
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Cardiac disorders
Coronary artery disease
|
0.65%
2/310 • Number of events 2 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/310 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Cardiac disorders
Myocardial infarction
|
0.65%
2/310 • Number of events 4 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Cardiac disorders
Palpitations
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/310 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Cardiac disorders
Sinus bradycardia
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/310 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Cardiac disorders
Tachycardia
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Vascular disorders
Aortic rupture
|
0.00%
0/310 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Vascular disorders
Embolism
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Vascular disorders
Haematoma
|
0.00%
0/310 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Vascular disorders
Haemorrhage
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Vascular disorders
Hypertension
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Vascular disorders
Hypotension
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Vascular disorders
Hypovolaemic shock
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Vascular disorders
Lymphoedema
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/310 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.99%
2/202 • Number of events 2 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/310 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.99%
2/202 • Number of events 2 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/310 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.99%
2/202 • Number of events 2 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.3%
4/310 • Number of events 7 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
5.0%
2/40 • Number of events 2 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.65%
2/310 • Number of events 4 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
2.5%
1/40 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Excessive dynamic airway collapse
|
0.00%
0/310 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/310 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.99%
2/202 • Number of events 3 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
2.5%
1/40 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.97%
3/310 • Number of events 3 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.65%
2/310 • Number of events 2 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/310 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
2.5%
1/40 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.00%
0/310 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.6%
5/310 • Number of events 10 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 2 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/310 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Gastrointestinal disorders
Appendix disorder
|
0.00%
0/310 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Gastrointestinal disorders
Constipation
|
0.65%
2/310 • Number of events 2 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.97%
3/310 • Number of events 3 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Gastrointestinal disorders
Diverticulum oesophageal
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Gastrointestinal disorders
Dysphagia
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.65%
2/310 • Number of events 2 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/310 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/310 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/310 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Gastrointestinal disorders
Parotid gland enlargement
|
0.00%
0/310 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.65%
2/310 • Number of events 2 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.99%
2/202 • Number of events 2 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.00%
0/310 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/310 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Hepatobiliary disorders
Suspected drug-induced liver injury
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.00%
0/310 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/310 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/310 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Gastrointestinal disorders
Vomiting
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/310 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
2.5%
1/40 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/310 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.65%
2/310 • Number of events 2 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Renal and urinary disorders
Calculus bladder
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/310 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.99%
2/202 • Number of events 3 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.00%
0/310 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.65%
2/310 • Number of events 5 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Renal and urinary disorders
Azotaemia
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Renal and urinary disorders
Haematuria
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Renal and urinary disorders
Renal failure
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/310 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Renal and urinary disorders
Urinary retention
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
General disorders
Asthenia
|
0.32%
1/310 • Number of events 2 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
General disorders
Brain death
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
General disorders
Chest pain
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
General disorders
Death
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
2.5%
1/40 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
General disorders
Fatigue
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
General disorders
Hernia
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/310 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
General disorders
Necrosis
|
0.65%
2/310 • Number of events 2 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
General disorders
Non-cardiac chest pain
|
0.65%
2/310 • Number of events 2 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
General disorders
Pyrexia
|
0.97%
3/310 • Number of events 4 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
2.5%
5/202 • Number of events 5 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
2.5%
1/40 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Investigations
Blood creatinine increased
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Investigations
Ejection fraction decreased
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Investigations
Neutrophil count decreased
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Investigations
Platelet count decreased
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Investigations
SARS-CoV-2 test positive
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Injury, poisoning and procedural complications
Aortic root compression
|
0.00%
0/310 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Injury, poisoning and procedural complications
Fall
|
0.97%
3/310 • Number of events 4 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.99%
2/202 • Number of events 2 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.97%
3/310 • Number of events 3 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Injury, poisoning and procedural complications
Open globe injury
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.65%
2/310 • Number of events 2 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Injury, poisoning and procedural complications
Scapula fracture
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/310 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Injury, poisoning and procedural complications
Traumatic fracture
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/310 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
Other adverse events
| Measure |
Acalabrutinib TN Cohort
n=310 participants at risk
Participants with treatment-naïve chronic lymphocytic leukemia received 100 mg acalabrutinib capsules twice daily.
|
Acalabrutinib R/R Cohort
n=202 participants at risk
Participants with relapsed/refractory chronic lymphocytic leukemia received 100 mg acalabrutinib capsules twice daily.
|
Acalabrutinib Prior BTKi Therapy Cohort
n=40 participants at risk
Participants with prior ibrutinib (BTKi) therapy received 100 mg acalabrutinib capsules twice daily.
|
|---|---|---|---|
|
Infections and infestations
Bronchitis
|
4.8%
15/310 • Number of events 26 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
8.4%
17/202 • Number of events 29 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
2.5%
1/40 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Infections and infestations
COVID-19
|
37.7%
117/310 • Number of events 157 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
37.6%
76/202 • Number of events 98 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
32.5%
13/40 • Number of events 20 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Infections and infestations
Cystitis
|
1.6%
5/310 • Number of events 5 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
2.0%
4/202 • Number of events 5 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
7.5%
3/40 • Number of events 3 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Infections and infestations
Ear infection
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
2.5%
5/202 • Number of events 5 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
5.0%
2/40 • Number of events 2 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Infections and infestations
Herpes zoster
|
7.4%
23/310 • Number of events 29 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
4.0%
8/202 • Number of events 9 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
15.0%
6/40 • Number of events 6 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Infections and infestations
Influenza
|
3.9%
12/310 • Number of events 14 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
6.4%
13/202 • Number of events 17 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
7.5%
3/40 • Number of events 7 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Infections and infestations
Localised infection
|
1.6%
5/310 • Number of events 5 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
7.5%
3/40 • Number of events 3 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Infections and infestations
Nasopharyngitis
|
8.4%
26/310 • Number of events 39 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
6.4%
13/202 • Number of events 19 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
10.0%
4/40 • Number of events 11 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Infections and infestations
Pharyngitis
|
1.3%
4/310 • Number of events 4 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
2.5%
5/202 • Number of events 6 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
5.0%
2/40 • Number of events 3 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Infections and infestations
Pneumonia
|
8.1%
25/310 • Number of events 29 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
12.4%
25/202 • Number of events 34 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
12.5%
5/40 • Number of events 8 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Infections and infestations
Sinusitis
|
4.2%
13/310 • Number of events 13 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
8.9%
18/202 • Number of events 25 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
15.0%
6/40 • Number of events 7 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Infections and infestations
Upper respiratory tract infection
|
17.1%
53/310 • Number of events 70 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
16.3%
33/202 • Number of events 60 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
7.5%
3/40 • Number of events 3 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Infections and infestations
Urinary tract infection
|
11.0%
34/310 • Number of events 59 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
11.9%
24/202 • Number of events 36 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
10.0%
4/40 • Number of events 19 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
5.8%
18/310 • Number of events 32 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
3.0%
6/202 • Number of events 9 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
5.2%
16/310 • Number of events 22 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
2.5%
5/202 • Number of events 5 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Blood and lymphatic system disorders
Anaemia
|
13.9%
43/310 • Number of events 66 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
18.3%
37/202 • Number of events 62 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
17.5%
7/40 • Number of events 14 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Blood and lymphatic system disorders
Haemorrhagic diathesis
|
0.97%
3/310 • Number of events 4 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.99%
2/202 • Number of events 3 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
5.0%
2/40 • Number of events 2 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
1.6%
5/310 • Number of events 5 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
1.5%
3/202 • Number of events 6 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
5.0%
2/40 • Number of events 2 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Blood and lymphatic system disorders
Neutropenia
|
4.8%
15/310 • Number of events 38 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
10.9%
22/202 • Number of events 69 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
2.5%
1/40 • Number of events 2 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.5%
17/310 • Number of events 26 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
8.4%
17/202 • Number of events 39 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
2.5%
1/40 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Immune system disorders
Immunodeficiency
|
0.00%
0/310 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
5.0%
2/40 • Number of events 2 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.5%
20/310 • Number of events 22 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
2.0%
4/202 • Number of events 4 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
5.0%
2/40 • Number of events 2 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Metabolism and nutrition disorders
Gout
|
0.65%
2/310 • Number of events 2 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
5.0%
2/40 • Number of events 3 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
4.8%
15/310 • Number of events 26 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
3.5%
7/202 • Number of events 17 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
5.0%
2/40 • Number of events 4 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
6.1%
19/310 • Number of events 27 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
6.9%
14/202 • Number of events 22 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
5.0%
2/40 • Number of events 2 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Psychiatric disorders
Insomnia
|
8.1%
25/310 • Number of events 31 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
5.0%
10/202 • Number of events 19 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
7.5%
3/40 • Number of events 4 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Nervous system disorders
Dizziness
|
15.8%
49/310 • Number of events 69 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
9.9%
20/202 • Number of events 34 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
12.5%
5/40 • Number of events 6 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Nervous system disorders
Headache
|
43.2%
134/310 • Number of events 213 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
38.6%
78/202 • Number of events 144 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
70.0%
28/40 • Number of events 69 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Nervous system disorders
Neuropathy peripheral
|
1.6%
5/310 • Number of events 5 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
2.0%
4/202 • Number of events 4 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
5.0%
2/40 • Number of events 3 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Nervous system disorders
Paraesthesia
|
2.6%
8/310 • Number of events 10 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
2.5%
5/202 • Number of events 5 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
7.5%
3/40 • Number of events 4 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Ear and labyrinth disorders
Ear pain
|
1.3%
4/310 • Number of events 4 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.99%
2/202 • Number of events 2 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
7.5%
3/40 • Number of events 4 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Ear and labyrinth disorders
Vertigo
|
2.9%
9/310 • Number of events 9 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
1.5%
3/202 • Number of events 4 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
5.0%
2/40 • Number of events 2 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Cardiac disorders
Atrial fibrillation
|
6.8%
21/310 • Number of events 26 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
2.0%
4/202 • Number of events 4 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
5.0%
2/40 • Number of events 4 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Cardiac disorders
Palpitations
|
5.5%
17/310 • Number of events 20 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
3.0%
6/202 • Number of events 8 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
7.5%
3/40 • Number of events 3 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Cardiac disorders
Tachycardia
|
1.3%
4/310 • Number of events 5 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
4.0%
8/202 • Number of events 8 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
5.0%
2/40 • Number of events 3 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Vascular disorders
Haematoma
|
8.1%
25/310 • Number of events 46 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
7.4%
15/202 • Number of events 20 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
7.5%
3/40 • Number of events 3 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Vascular disorders
Hot flush
|
1.6%
5/310 • Number of events 5 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
5.0%
2/40 • Number of events 2 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Vascular disorders
Hypertension
|
11.9%
37/310 • Number of events 99 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
7.4%
15/202 • Number of events 35 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
5.0%
2/40 • Number of events 4 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.8%
46/310 • Number of events 66 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
14.9%
30/202 • Number of events 47 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
10.0%
4/40 • Number of events 7 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
12.3%
38/310 • Number of events 53 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
7.4%
15/202 • Number of events 20 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
15.0%
6/40 • Number of events 9 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
10.0%
31/310 • Number of events 57 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
8.4%
17/202 • Number of events 29 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
15.0%
6/40 • Number of events 9 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/310 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
5.0%
2/40 • Number of events 2 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
1.3%
4/310 • Number of events 4 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
5.0%
10/202 • Number of events 11 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
2.5%
1/40 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/310 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
5.0%
2/40 • Number of events 5 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.65%
2/310 • Number of events 2 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.99%
2/202 • Number of events 3 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
7.5%
3/40 • Number of events 3 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.65%
2/310 • Number of events 3 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
2.5%
5/202 • Number of events 5 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
5.0%
2/40 • Number of events 2 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Gastrointestinal disorders
Abdominal pain
|
9.7%
30/310 • Number of events 43 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
8.9%
18/202 • Number of events 22 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
10.0%
4/40 • Number of events 5 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.5%
14/310 • Number of events 16 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
5.4%
11/202 • Number of events 14 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
7.5%
3/40 • Number of events 3 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Gastrointestinal disorders
Constipation
|
18.4%
57/310 • Number of events 74 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
7.4%
15/202 • Number of events 19 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
5.0%
2/40 • Number of events 3 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Gastrointestinal disorders
Dental caries
|
0.65%
2/310 • Number of events 2 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
5.0%
2/40 • Number of events 2 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Gastrointestinal disorders
Diarrhoea
|
34.5%
107/310 • Number of events 173 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
29.7%
60/202 • Number of events 140 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
32.5%
13/40 • Number of events 28 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Gastrointestinal disorders
Dyspepsia
|
4.2%
13/310 • Number of events 16 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
5.9%
12/202 • Number of events 16 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
10.0%
4/40 • Number of events 4 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Gastrointestinal disorders
Flatulence
|
1.9%
6/310 • Number of events 11 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 2 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
5.0%
2/40 • Number of events 2 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Gastrointestinal disorders
Gastritis
|
2.9%
9/310 • Number of events 11 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.99%
2/202 • Number of events 3 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
5.0%
2/40 • Number of events 3 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Gastrointestinal disorders
Nausea
|
20.3%
63/310 • Number of events 83 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
18.3%
37/202 • Number of events 47 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
20.0%
8/40 • Number of events 25 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Gastrointestinal disorders
Stomatitis
|
2.3%
7/310 • Number of events 11 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
2.0%
4/202 • Number of events 4 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
7.5%
3/40 • Number of events 3 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
31/310 • Number of events 41 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
8.4%
17/202 • Number of events 21 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
15.0%
6/40 • Number of events 10 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
3.2%
10/310 • Number of events 12 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
3.0%
6/202 • Number of events 6 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
5.0%
2/40 • Number of events 3 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.6%
8/310 • Number of events 9 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.99%
2/202 • Number of events 2 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
5.0%
2/40 • Number of events 2 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.9%
9/310 • Number of events 11 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
2.0%
4/202 • Number of events 4 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
5.0%
2/40 • Number of events 2 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
3.2%
10/310 • Number of events 17 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.99%
2/202 • Number of events 8 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
5.0%
2/40 • Number of events 5 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.32%
1/310 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
5.0%
2/40 • Number of events 2 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
7.4%
23/310 • Number of events 30 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
4.0%
8/202 • Number of events 21 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
10.0%
4/40 • Number of events 6 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.7%
24/310 • Number of events 32 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
5.4%
11/202 • Number of events 13 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
5.0%
2/40 • Number of events 2 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.3%
32/310 • Number of events 40 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
5.0%
10/202 • Number of events 13 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
7.5%
3/40 • Number of events 4 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
6.8%
21/310 • Number of events 33 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
3.0%
6/202 • Number of events 6 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
7.5%
3/40 • Number of events 6 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
6.1%
19/310 • Number of events 34 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
5.0%
10/202 • Number of events 10 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
7.5%
3/40 • Number of events 3 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.5%
79/310 • Number of events 130 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
15.8%
32/202 • Number of events 53 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
32.5%
13/40 • Number of events 14 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.3%
4/310 • Number of events 4 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
2.0%
4/202 • Number of events 4 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
5.0%
2/40 • Number of events 2 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.5%
51/310 • Number of events 64 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
8.4%
17/202 • Number of events 20 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
12.5%
5/40 • Number of events 6 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
2.6%
8/310 • Number of events 8 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
1.5%
3/202 • Number of events 3 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
7.5%
3/40 • Number of events 3 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.5%
20/310 • Number of events 21 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
2.0%
4/202 • Number of events 5 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
10.0%
4/40 • Number of events 4 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
1.9%
6/310 • Number of events 7 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
3.0%
6/202 • Number of events 7 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
7.5%
3/40 • Number of events 5 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.3%
38/310 • Number of events 63 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
10.4%
21/202 • Number of events 27 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
10.0%
4/40 • Number of events 4 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
3.5%
11/310 • Number of events 11 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
2.5%
5/202 • Number of events 6 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
5.0%
2/40 • Number of events 2 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.7%
30/310 • Number of events 36 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
6.4%
13/202 • Number of events 18 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
7.5%
3/40 • Number of events 3 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Renal and urinary disorders
Haematuria
|
4.2%
13/310 • Number of events 18 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
3.5%
7/202 • Number of events 10 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
5.0%
2/40 • Number of events 2 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
General disorders
Asthenia
|
6.5%
20/310 • Number of events 23 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
4.5%
9/202 • Number of events 11 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
17.5%
7/40 • Number of events 8 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
General disorders
Fatigue
|
21.6%
67/310 • Number of events 98 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
12.4%
25/202 • Number of events 50 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
25.0%
10/40 • Number of events 21 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
General disorders
Influenza like illness
|
5.5%
17/310 • Number of events 22 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
4.5%
9/202 • Number of events 13 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
22.5%
9/40 • Number of events 18 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
General disorders
Malaise
|
0.65%
2/310 • Number of events 2 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
1.5%
3/202 • Number of events 3 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
5.0%
2/40 • Number of events 3 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
General disorders
Non-cardiac chest pain
|
4.8%
15/310 • Number of events 22 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
4.0%
8/202 • Number of events 8 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
5.0%
2/40 • Number of events 2 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
General disorders
Oedema peripheral
|
11.6%
36/310 • Number of events 55 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
6.4%
13/202 • Number of events 18 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
10.0%
4/40 • Number of events 7 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
General disorders
Peripheral swelling
|
2.6%
8/310 • Number of events 10 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
1.5%
3/202 • Number of events 6 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
7.5%
3/40 • Number of events 8 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
General disorders
Pyrexia
|
8.1%
25/310 • Number of events 39 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
9.4%
19/202 • Number of events 28 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
10.0%
4/40 • Number of events 4 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Investigations
Alanine aminotransferase increased
|
5.2%
16/310 • Number of events 18 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
5.4%
11/202 • Number of events 32 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
2.5%
1/40 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Investigations
Blood creatinine increased
|
5.2%
16/310 • Number of events 20 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
4.0%
8/202 • Number of events 10 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
10.0%
4/40 • Number of events 4 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.65%
2/310 • Number of events 2 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
5.0%
2/40 • Number of events 2 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Investigations
Immunoglobulins decreased
|
0.00%
0/310 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.50%
1/202 • Number of events 1 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
5.0%
2/40 • Number of events 2 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Investigations
Lymphocyte count increased
|
0.65%
2/310 • Number of events 2 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
2.5%
5/202 • Number of events 11 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
5.0%
2/40 • Number of events 3 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Investigations
Platelet count decreased
|
3.9%
12/310 • Number of events 19 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
6.9%
14/202 • Number of events 31 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
7.5%
3/40 • Number of events 5 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Investigations
Weight decreased
|
3.5%
11/310 • Number of events 11 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
3.0%
6/202 • Number of events 8 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
5.0%
2/40 • Number of events 3 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Investigations
Weight increased
|
3.2%
10/310 • Number of events 25 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
2.5%
5/202 • Number of events 7 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
7.5%
3/40 • Number of events 3 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Injury, poisoning and procedural complications
Contusion
|
29.0%
90/310 • Number of events 123 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
21.3%
43/202 • Number of events 89 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
22.5%
9/40 • Number of events 11 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Injury, poisoning and procedural complications
Fall
|
8.1%
25/310 • Number of events 37 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
3.0%
6/202 • Number of events 6 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
7.5%
3/40 • Number of events 3 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
|
Injury, poisoning and procedural complications
Immunisation reaction
|
1.9%
6/310 • Number of events 8 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
0.00%
0/202 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
5.0%
2/40 • Number of events 2 • Up to safety follow-up period (about 30 days from last dose) (approximately 74 months)
Safety analysis set included participants who had received ≥ 1 dose (partial or in full) of study intervention.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee No unpublished information may be disclosed without prior written approval from AstraZeneca.
- Publication restrictions are in place
Restriction type: OTHER