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Extension Study to Evaluate the Safety and Tolerability of Tezepelumab in Adults and Adolescents With Severe, Uncontrolled Asthma (DESTINATION)

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ClinicalTrials.gov Identifier: NCT03706079
Recruitment Status : Completed
First Posted : October 15, 2018
Results First Posted : February 9, 2023
Last Update Posted : June 6, 2023
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Asthma
Interventions Biological: Tezepelumab
Other: Placebo
Enrollment 951
Recruitment Details Participants who completed treatment and attended end of treatment visit in predecessor studies NAVIGATOR (NCT03347279) or SOURCE (NCT03406078) were eligible for this long-term extension study. In the predecessor studies, a total of 1059 and 150 subjects were randomised and dosed in NAVIGATOR and SOURCE respectively. In DESTINATION, a total of 951 subjects (827 from NAVIGATOR and 124 from SOURCE) were randomised at 182 centres in 18 countries to receive treatment with tezepelumab or placebo.
Pre-assignment Details Of the 1209 patients randomized and dosed in predecessor studies, 951 were randomised in DESTINATION and 950 received treatment. The patients receiving tezepelumab in the predecessors continued to receive tezepelumab, while patients receiving placebo in the predecessors were re-randomized 1:1 to either receive tezepelumab in DESTINATION or to continue placebo, resulting in a 3:1 randomization ratio in DESTINATION.
Arm/Group Title NAVIGATOR Rand Teze NAVIGATOR Rand Pbo NAVIGATOR Pbo to Teze SOURCE Rand Teze SOURCE Rand Pbo SOURCE Pbo to Teze
Hide Arm/Group Description All subjects randomised to tezepelumab in the NAVIGATOR predecessor and treated with at least one dose in the predecessor, regardless of whether they participated in the DESTINATION study. All subjects randomised to placebo in the NAVIGATOR predecessor and treated with at least one dose in the predecessor, regardless of whether they participated in the DESTINATION study. For subjects switching to tezepelumab in DESTINATION, data collected during the placebo (predecessor) period are contained in this column, while data collected after the first dose of tezepelumab in DESTINATION are presented in the NAVIGATOR Pbo to Teze arm. All subjects randomised to placebo in the NAVIGATOR predecessor and re-randomised to tezepelumab in DESTINATION. Only data collected after the first dose of tezepelumab in DESTINATION are presented in this column. All subjects randomised to tezepelumab in the SOURCE predecessor and treated with at least one dose in the predecessor, regardless of whether they participated in the DESTINATION study. All subjects randomised to placebo in the SOURCE predecessor and treated with at least one dose in the predecessor, regardless of whether they participated in the DESTINATION study. For subjects switching to tezepelumab in DESTINATION, data collected during the placebo (predecessor) period are contained in this column, while data collected after the first dose of tezepelumab in DESTINATION are presented in the SOURCE Pbo to Teze arm. All subjects randomised to placebo in the SOURCE predecessor and re-randomised to tezepelumab in DESTINATION. Only data collected after the first dose of tezepelumab in DESTINATION are presented in this column.
Period Title: Predecessor Study
Started 529 532 0 [1] 74 76 0 [1]
Received Treatment 528 531 0 [1] 74 76 0 [1]
Completed 513 509 0 [1] 68 73 0 [1]
Not Completed 16 23 0 6 3 0
Reason Not Completed
Death             0             2             0             1             0             0
Lost to Follow-up             5             2             0             0             1             0
Withdrawal by Subject             8             15             0             5             2             0
Did not receive treatment / Non-compliance with protocol / did not complete safety follow-up visits             3             4             0             0             0             0
[1]
Not Applicable for predecessor period
Period Title: Long Term Extension (DESTINATION)
Started 415 206 206 60 32 32
Received Treatment 415 206 205 60 32 32
Completed 400 200 198 58 28 31
Not Completed 15 6 8 2 4 1
Reason Not Completed
Due to COVID-19 pandemic             0             0             0             0             0             1
Did not complete safety follow-up visits             1             0             2             0             0             0
Pregnancy             1             0             0             0             0             0
Withdrawal by Subject             3             3             3             1             3             0
Lost to Follow-up             2             1             1             0             1             0
Death             8             2             2             1             0             0
Arm/Group Title NAVIGATOR Rand Teze NAVIGATOR Rand Pbo SOURCE Rand Teze SOURCE Rand Pbo Total
Hide Arm/Group Description All subjects randomised to tezepelumab in the NAVIGATOR predecessor and treated with at least one dose in the predecessor, regardless of whether they participated in the DESTINATION study. All subjects randomised to placebo in the NAVIGATOR predecessor and treated with at least one dose in the predecessor, regardless of whether they participated in the DESTINATION study and regardless of their treatment assignment in DESTINATION. All subjects randomised to tezepelumab in the SOURCE predecessor and treated with at least one dose in the predecessor, regardless of whether they participated in the DESTINATION study. All subjects randomised to placebo in the SOURCE predecessor and treated with at least one dose in the predecessor, regardless of whether they participated in the DESTINATION study and regardless of their treatment assignment in DESTINATION. Total of all reporting groups
Overall Number of Baseline Participants 528 531 74 76 1209
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 528 participants 531 participants 74 participants 76 participants 1209 participants
<=18 years
41
   7.8%
41
   7.7%
0
   0.0%
0
   0.0%
82
   6.8%
Between 18 and 65 years
391
  74.1%
416
  78.3%
58
  78.4%
62
  81.6%
927
  76.7%
>=65 years
96
  18.2%
74
  13.9%
16
  21.6%
14
  18.4%
200
  16.5%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 528 participants 531 participants 74 participants 76 participants 1209 participants
49.9  (16.3) 49.0  (15.9) 53.5  (12.1) 53.4  (11.9) 49.9  (15.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 528 participants 531 participants 74 participants 76 participants 1209 participants
Female
335
  63.4%
337
  63.5%
49
  66.2%
45
  59.2%
766
  63.4%
Male
193
  36.6%
194
  36.5%
25
  33.8%
31
  40.8%
443
  36.6%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 528 participants 531 participants 74 participants 76 participants 1209 participants
Hispanic or Latino 83 81 10 14 188
Not Hispanic or Latino 445 450 64 62 1021
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 528 participants 531 participants 74 participants 76 participants 1209 participants
American Indian or Alaska Native 0 1 0 0 1
Asian 146 149 11 11 317
Black of African American 30 31 1 0 62
Native Hawaiian or Other Pacific Islander 1 0 0 0 1
Other 19 23 0 1 43
White 332 327 62 64 785
1.Primary Outcome
Title Exposure Adjusted Incidence Rates of AEs/SAEs
Hide Description Includes adverse events with an onset date between the date of first dose of IP in the predecessor and minimum (date of last dose of IP + 33 days, date of death, date of study withdrawal, day prior to start of another biologic). The analysis is based on the Safety Analysis Set. Exposure adjusted rates are defined as number of subjects with AEs divided by total time at risk across all subjects, multiplied by 100
Time Frame Baseline (Week 0 in predecessor study) to Week 104. For subjects switching treatments from placebo in the predecessor to tezepelumab in DESTINATION, all data collected after first dose of tezepelumab are excluded.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NAVIGATOR Rand Teze NAVIGATOR Rand Pbo SOURCE Rand Teze SOURCE Rand Pbo
Hide Arm/Group Description:
All subjects randomised to tezepelumab in the NAVIGATOR predecessor and treated with at least one dose in the predecessor, regardless of whether they participated in the DESTINATION study.
All subjects randomised to placebo in the NAVIGATOR predecessor and treated with at least one dose in the predecessor, regardless of whether they participated in the DESTINATION study. For subjects switching treatments from placebo in the predecessor to tezepelumab in DESTINATION, all data collected after first dose of tezepelumab are excluded.
All subjects randomised to tezepelumab in the SOURCE predecessor and treated with at least one dose in the predecessor, regardless of whether they participated in the DESTINATION study.
All subjects randomised to placebo in the SOURCE predecessor and treated with at least one dose in the predecessor, regardless of whether they participated in the DESTINATION study. For subjects switching treatments from placebo in the predecessor to tezepelumab in DESTINATION, all data collected after first dose of tezepelumab are excluded.
Overall Number of Participants Analyzed 528 531 74 76
Measure Type: Number
Unit of Measure: Patients with AEs per 100 person-years
Any AE incidence rate 49.62 62.66 47.15 69.97
Any AE with outcome=death incidence rate 0.76 0.14 1.55 0.00
Any SAE incidence rate 7.85 12.45 13.14 17.99
Any AE leading to discontinuation of IP incidence rate 1.64 3.00 1.55 2.00
2.Primary Outcome
Title Total Time at Risk
Hide Description Includes time between the date of first dose of IP in the predecessor and minimum (date of last dose of IP + 33 days, date of death, date of study withdrawal, day prior to start of another biologic). The analysis is based on the Safety Analysis Set.
Time Frame Baseline (Week 0 in predecessor study) to Week 104. For subjects switching treatments from placebo in the predecessor to tezepelumab in DESTINATION, all data collected after first dose of tezepelumab are excluded.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NAVIGATOR Rand Teze NAVIGATOR Rand Pbo SOURCE Rand Teze SOURCE Rand Pbo
Hide Arm/Group Description:
All subjects randomised to tezepelumab in the NAVIGATOR predecessor and treated with at least one dose in the predecessor, regardless of whether they participated in the DESTINATION study.
All subjects randomised to placebo in the NAVIGATOR predecessor and treated with at least one dose in the predecessor, regardless of whether they participated in the DESTINATION study. For subjects switching treatments from placebo in the predecessor to tezepelumab in DESTINATION, all data collected after first dose of tezepelumab are excluded.
All subjects randomised to tezepelumab in the SOURCE predecessor and treated with at least one dose in the predecessor, regardless of whether they participated in the DESTINATION study.
All subjects randomised to placebo in the SOURCE predecessor and treated with at least one dose in the predecessor, regardless of whether they participated in the DESTINATION study. For subjects switching treatments from placebo in the predecessor to tezepelumab in DESTINATION, all data collected after first dose of tezepelumab are excluded.
Overall Number of Participants Analyzed 528 531 74 76
Measure Type: Number
Unit of Measure: Year
917.0 699.0 129.4 100.0
3.Secondary Outcome
Title Annualized Asthma Exacerbation Rate (AAER)
Hide Description The annualized exacerbation rate is based on exacerbations reported by the investigator in the eCRF. The analysis is based on the primary population (Full Analysis Set)
Time Frame Baseline (Week 0 in predecessor study) to Week 104. For subjects switching treatments from placebo in the predecessor to tezepelumab in DESTINATION, all data collected after first dose of tezepelumab are excluded.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NAVIGATOR Rand Teze NAVIGATOR Rand Pbo SOURCE Rand Teze SOURCE Rand Pbo
Hide Arm/Group Description:
All subjects randomised to tezepelumab in the NAVIGATOR predecessor and treated with at least one dose in the predecessor, regardless of whether they participated in the DESTINATION study.
All subjects randomised to placebo in the NAVIGATOR predecessor and treated with at least one dose in the predecessor, regardless of whether they participated in the DESTINATION study. For subjects switching treatments from placebo in the predecessor to tezepelumab in DESTINATION, all data collected after first dose of tezepelumab are excluded.
All subjects randomised to tezepelumab in the SOURCE predecessor and treated with at least one dose in the predecessor, regardless of whether they participated in the DESTINATION study.
All subjects randomised to placebo in the SOURCE predecessor and treated with at least one dose in the predecessor, regardless of whether they participated in the DESTINATION study. For subjects switching treatments from placebo in the predecessor to tezepelumab in DESTINATION, all data collected after first dose of tezepelumab are excluded.
Overall Number of Participants Analyzed 528 531 74 76
Least Squares Mean (95% Confidence Interval)
Unit of Measure: events per year
0.82
(0.71 to 0.95)
1.93
(1.70 to 2.20)
1.07
(0.76 to 1.51)
1.76
(1.27 to 2.45)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NAVIGATOR Rand Teze, NAVIGATOR Rand Pbo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 0.42
Confidence Interval (2-Sided) 95%
0.35 to 0.51
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection SOURCE Rand Teze, SOURCE Rand Pbo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 0.61
Confidence Interval (2-Sided) 95%
0.38 to 0.96
Estimation Comments [Not Specified]
Time Frame Baseline (Week 0 in predecessor study) to long-term extension completion (either weeks 104 or 116). Includes AEs with onset date between the date of first dose of IP and and the long-term extension completion or withdrawal date (on-study period)
Adverse Event Reporting Description The subjects switching treatments from placebo in the predecessor to tezepelumab in DESTINATION are included in both Rand Pbo and Pbo to Teze arms. Their data collected during the placebo (predecessor) period are contained within the Rand Pbo arm, while data collected after the first dose of tezepelumab in DESTINATION are presented in the Pbo to Teze arm. Note the primary objective in the Outcome Measures section presents on-treatment safety as opposed to on-study safety.
 
Arm/Group Title NAVIGATOR Rand Teze NAVIGATOR Rand Pbo NAVIGATOR Pbo to Teze SOURCE Rand Teze SOURCE Rand Pbo SOURCE Pbo to Teze
Hide Arm/Group Description All subjects randomised to tezepelumab in the NAVIGATOR predecessor and treated with at least one dose in the predecessor, regardless of whether they participated in the DESTINATION study. All subjects randomised to placebo in the NAVIGATOR predecessor and treated with at least one dose in the predecessor, regardless of whether they participated in the DESTINATION study. For subjects switching to tezepelumab in DESTINATION, data collected during the placebo (predecessor) period are contained in this column, while data collected after the first dose of tezepelumab in DESTINATION are presented in the NAVIGATOR Pbo to Teze arm. All subjects randomised to placebo in the NAVIGATOR predecessor and re-randomised to tezepelumab in DESTINATION. Only data collected after the first dose of tezepelumab in DESTINATION are presented in this column. All subjects randomised to tezepelumab in the SOURCE predecessor and treated with at least one dose in the predecessor, regardless of whether they participated in the DESTINATION study. All subjects randomised to placebo in the SOURCE predecessor and treated with at least one dose in the predecessor, regardless of whether they participated in the DESTINATION study. For subjects switching to tezepelumab in DESTINATION, data collected during the placebo (predecessor) period are contained in this column, while data collected after the first dose of tezepelumab in DESTINATION are presented in the SOURCE Pbo to Teze arm. All subjects randomised to placebo in the SOURCE predecessor and re-randomised to tezepelumab in DESTINATION. Only data collected after the first dose of tezepelumab in DESTINATION are presented in this column.
All-Cause Mortality
NAVIGATOR Rand Teze NAVIGATOR Rand Pbo NAVIGATOR Pbo to Teze SOURCE Rand Teze SOURCE Rand Pbo SOURCE Pbo to Teze
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   8/528 (1.52%)      5/531 (0.94%)      1/206 (0.49%)      2/74 (2.70%)      0/76 (0.00%)      0/32 (0.00%)    
Hide Serious Adverse Events
NAVIGATOR Rand Teze NAVIGATOR Rand Pbo NAVIGATOR Pbo to Teze SOURCE Rand Teze SOURCE Rand Pbo SOURCE Pbo to Teze
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   82/528 (15.53%)      94/531 (17.70%)      17/206 (8.25%)      18/74 (24.32%)      19/76 (25.00%)      4/32 (12.50%)    
Blood and lymphatic system disorders             
Immune thrombocytopenia  1  1/528 (0.19%)  1 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Cardiac disorders             
Cardiac failure congestive  1  2/528 (0.38%)  2 0/531 (0.00%)  0 1/206 (0.49%)  1 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Coronary artery disease  1  2/528 (0.38%)  2 0/531 (0.00%)  0 1/206 (0.49%)  1 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Coronary artery occlusion  1  1/528 (0.19%)  1 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Myocardial infarction  1  0/528 (0.00%)  0 0/531 (0.00%)  0 0/206 (0.00%)  0 1/74 (1.35%)  1 0/76 (0.00%)  0 0/32 (0.00%)  0
Myocarditis  1  0/528 (0.00%)  0 0/531 (0.00%)  0 1/206 (0.49%)  1 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Palpitations  1  0/528 (0.00%)  0 1/531 (0.19%)  1 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Prinzmetal angina  1  0/528 (0.00%)  0 0/531 (0.00%)  0 0/206 (0.00%)  0 1/74 (1.35%)  1 0/76 (0.00%)  0 0/32 (0.00%)  0
Supraventricular tachycardia  1  0/528 (0.00%)  0 0/531 (0.00%)  0 0/206 (0.00%)  0 1/74 (1.35%)  2 0/76 (0.00%)  0 0/32 (0.00%)  0
Ventricular extrasystoles  1  1/528 (0.19%)  1 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Acute left ventricular failure  1  0/528 (0.00%)  0 0/531 (0.00%)  0 1/206 (0.49%)  1 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Acute myocardial infarction  1  2/528 (0.38%)  2 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Aortic valve stenosis  1  1/528 (0.19%)  1 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Atrial flutter  1  1/528 (0.19%)  1 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Atrial tachycardia  1  0/528 (0.00%)  0 0/531 (0.00%)  0 1/206 (0.49%)  1 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Cardiac arrest  1  0/528 (0.00%)  0 0/531 (0.00%)  0 0/206 (0.00%)  0 1/74 (1.35%)  1 0/76 (0.00%)  0 0/32 (0.00%)  0
Cardiac failure  1  0/528 (0.00%)  0 1/531 (0.19%)  1 0/206 (0.00%)  0 1/74 (1.35%)  1 0/76 (0.00%)  0 0/32 (0.00%)  0
Congenital, familial and genetic disorders             
Encephalocele  1  0/528 (0.00%)  0 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 1/32 (3.13%)  1
Hypertrophic cardiomyopathy  1  0/528 (0.00%)  0 1/531 (0.19%)  1 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Ear and labyrinth disorders             
Vertigo positional  1  0/528 (0.00%)  0 1/531 (0.19%)  1 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Endocrine disorders             
Hyperparathyroidism primary  1  1/528 (0.19%)  1 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Eye disorders             
Cataract  1  1/528 (0.19%)  2 2/531 (0.38%)  2 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Uveitis  1  0/528 (0.00%)  0 1/531 (0.19%)  1 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Gastrointestinal disorders             
Anal fistula  1  1/528 (0.19%)  1 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Diverticular perforation  1  1/528 (0.19%)  1 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Gastric polyps  1  0/528 (0.00%)  0 0/531 (0.00%)  0 1/206 (0.49%)  1 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Gastrointestinal haemorrhage  1  0/528 (0.00%)  0 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 1/32 (3.13%)  1
Ileus paralytic  1  1/528 (0.19%)  1 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Inguinal hernia  1  0/528 (0.00%)  0 2/531 (0.38%)  3 1/206 (0.49%)  1 1/74 (1.35%)  1 1/76 (1.32%)  1 0/32 (0.00%)  0
Large intestine polyp  1  1/528 (0.19%)  1 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Rectal haemorrhage  1  1/528 (0.19%)  1 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Oesophageal achalasia  1  0/528 (0.00%)  0 1/531 (0.19%)  1 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Pancreatitis acute  1  1/528 (0.19%)  1 1/531 (0.19%)  3 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Pancreatitis necrotising  1  0/528 (0.00%)  0 1/531 (0.19%)  1 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Obstruction gastric  1  1/528 (0.19%)  1 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Colitis  1  1/528 (0.19%)  1 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Colitis ischaemic  1  0/528 (0.00%)  0 1/531 (0.19%)  1 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Umbilical hernia  1  1/528 (0.19%)  1 1/531 (0.19%)  1 0/206 (0.00%)  0 0/74 (0.00%)  0 1/76 (1.32%)  1 0/32 (0.00%)  0
General disorders             
Death  1  1/528 (0.19%)  1 3/531 (0.56%)  3 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Impaired healing  1  0/528 (0.00%)  0 0/531 (0.00%)  0 1/206 (0.49%)  1 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Non-cardiac chest pain  1  1/528 (0.19%)  1 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Chest discomfort  1  0/528 (0.00%)  0 1/531 (0.19%)  1 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Malaise  1  1/528 (0.19%)  1 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Gait disturbance  1  0/528 (0.00%)  0 0/531 (0.00%)  0 1/206 (0.49%)  1 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Hepatobiliary disorders             
Cholecystitis chronic  1  0/528 (0.00%)  0 0/531 (0.00%)  0 1/206 (0.49%)  1 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Cholecystitis acute  1  0/528 (0.00%)  0 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 1/76 (1.32%)  1 0/32 (0.00%)  0
Drug-induced liver injury  1  0/528 (0.00%)  0 1/531 (0.19%)  1 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Cholecystitis chronic  1  0/528 (0.00%)  0 1/531 (0.19%)  1 1/206 (0.49%)  1 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Cholelithiasis  1  2/528 (0.38%)  2 1/531 (0.19%)  1 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Immune system disorders             
Anaphylactic reaction  1  0/528 (0.00%)  0 1/531 (0.19%)  1 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Drug hypersensitivity  1  1/528 (0.19%)  1 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Infections and infestations             
Viral upper respiratory tract infection  1  0/528 (0.00%)  0 1/531 (0.19%)  1 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Upper respiratory tract infection  1  1/528 (0.19%)  1 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Breast abscess  1  1/528 (0.19%)  1 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Bacterial pyelonephritis  1  1/528 (0.19%)  1 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Covid-19  1  3/528 (0.57%)  3 2/531 (0.38%)  2 0/206 (0.00%)  0 0/74 (0.00%)  0 1/76 (1.32%)  1 0/32 (0.00%)  0
Covid-19 pneumonia  1  3/528 (0.57%)  3 2/531 (0.38%)  2 0/206 (0.00%)  0 3/74 (4.05%)  3 0/76 (0.00%)  0 0/32 (0.00%)  0
Cellulitis  1  1/528 (0.19%)  1 2/531 (0.38%)  2 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
H1n1 influenza  1  0/528 (0.00%)  0 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 1/76 (1.32%)  1 0/32 (0.00%)  0
Gastroenteritis  1  1/528 (0.19%)  1 2/531 (0.38%)  2 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Gastroenteritis viral  1  1/528 (0.19%)  1 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Intervertebral discitis  1  0/528 (0.00%)  0 0/531 (0.00%)  0 0/206 (0.00%)  0 1/74 (1.35%)  1 0/76 (0.00%)  0 0/32 (0.00%)  0
Lower respiratory tract infection bacterial  1  0/528 (0.00%)  0 2/531 (0.38%)  5 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Meningitis bacterial  1  1/528 (0.19%)  1 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Pneumonia bacterial  1  3/528 (0.57%)  3 2/531 (0.38%)  2 1/206 (0.49%)  1 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Pneumonia haemophilus  1  0/528 (0.00%)  0 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 1/32 (3.13%)  1
Osteomyelitis  1  1/528 (0.19%)  1 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Pneumonia streptococcal  1  0/528 (0.00%)  0 1/531 (0.19%)  1 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Periorbital cellulitis  1  0/528 (0.00%)  0 1/531 (0.19%)  1 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Pneumonia  1  1/528 (0.19%)  2 1/531 (0.19%)  1 0/206 (0.00%)  0 1/74 (1.35%)  1 2/76 (2.63%)  2 0/32 (0.00%)  0
Pneumonia klebsiella  1  0/528 (0.00%)  0 1/531 (0.19%)  1 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Atypical pneumonia  1  1/528 (0.19%)  1 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Cholecystitis infective  1  1/528 (0.19%)  1 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Herpes zoster oticus  1  1/528 (0.19%)  1 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Diverticulitis  1  2/528 (0.38%)  2 1/531 (0.19%)  1 0/206 (0.00%)  0 1/74 (1.35%)  1 0/76 (0.00%)  0 0/32 (0.00%)  0
Gastroenteritis salmonella  1  1/528 (0.19%)  1 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Pneumonia viral  1  0/528 (0.00%)  0 1/531 (0.19%)  1 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Sepsis  1  1/528 (0.19%)  1 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Septic shock  1  2/528 (0.38%)  2 1/531 (0.19%)  1 0/206 (0.00%)  0 1/74 (1.35%)  1 0/76 (0.00%)  0 0/32 (0.00%)  0
Anal abscess  1  1/528 (0.19%)  1 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Appendicitis  1  0/528 (0.00%)  0 1/531 (0.19%)  1 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Influenza  1  1/528 (0.19%)  1 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Lower respiratory tract infection  1  0/528 (0.00%)  0 1/531 (0.19%)  1 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Lung abscess  1  0/528 (0.00%)  0 1/531 (0.19%)  1 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Pneumonia aspiration  1  1/528 (0.19%)  1 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Pneumonia staphylococcal  1  1/528 (0.19%)  1 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Injury, poisoning and procedural complications             
Head injury  1  0/528 (0.00%)  0 1/531 (0.19%)  1 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Hip fracture  1  1/528 (0.19%)  1 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Ligament sprain  1  1/528 (0.19%)  1 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Lower limb fracture  1  0/528 (0.00%)  0 1/531 (0.19%)  1 0/206 (0.00%)  0 0/74 (0.00%)  0 1/76 (1.32%)  1 0/32 (0.00%)  0
Periprocedural myocardial infarction  1  1/528 (0.19%)  1 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Radius fracture  1  1/528 (0.19%)  1 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Road traffic accident  1  0/528 (0.00%)  0 1/531 (0.19%)  1 0/206 (0.00%)  0 0/74 (0.00%)  0 1/76 (1.32%)  1 0/32 (0.00%)  0
Skin laceration  1  0/528 (0.00%)  0 1/531 (0.19%)  1 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Ulna fracture  1  1/528 (0.19%)  1 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Ligament rupture  1  3/528 (0.57%)  3 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Spinal compression fracture  1  0/528 (0.00%)  0 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 1/76 (1.32%)  1 0/32 (0.00%)  0
Tendon rupture  1  1/528 (0.19%)  1 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Tibia fracture  1  0/528 (0.00%)  0 1/531 (0.19%)  1 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Incisional hernia  1  1/528 (0.19%)  1 0/531 (0.00%)  0 0/206 (0.00%)  0 1/74 (1.35%)  1 0/76 (0.00%)  0 0/32 (0.00%)  0
Lumbar vertebral fracture  1  0/528 (0.00%)  0 1/531 (0.19%)  1 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Investigations             
Blood creatine phosphokinase increased  1  0/528 (0.00%)  0 1/531 (0.19%)  1 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Metabolism and nutrition disorders             
Diabetes mellitus inadequate control  1  0/528 (0.00%)  0 1/531 (0.19%)  1 0/206 (0.00%)  0 1/74 (1.35%)  1 0/76 (0.00%)  0 0/32 (0.00%)  0
Diabetic ketoacidosis  1  0/528 (0.00%)  0 1/531 (0.19%)  2 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Gout  1  0/528 (0.00%)  0 1/531 (0.19%)  1 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Type 1 diabetes mellitus  1  0/528 (0.00%)  0 1/531 (0.19%)  1 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Type 2 diabetes mellitus  1  0/528 (0.00%)  0 1/531 (0.19%)  1 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Musculoskeletal and connective tissue disorders             
Muscle necrosis  1  0/528 (0.00%)  0 1/531 (0.19%)  1 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Myositis  1  1/528 (0.19%)  1 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Amyotrophy  1  0/528 (0.00%)  0 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 1/76 (1.32%)  1 0/32 (0.00%)  0
Arthralgia  1  0/528 (0.00%)  0 0/531 (0.00%)  0 0/206 (0.00%)  0 1/74 (1.35%)  1 0/76 (0.00%)  0 0/32 (0.00%)  0
Arthritis  1  0/528 (0.00%)  0 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 1/76 (1.32%)  1 0/32 (0.00%)  0
Bone cyst  1  1/528 (0.19%)  1 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Exostosis  1  0/528 (0.00%)  0 0/531 (0.00%)  0 1/206 (0.49%)  1 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Intervertebral disc protrusion  1  1/528 (0.19%)  1 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Lumbar spinal stenosis  1  1/528 (0.19%)  1 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Muscle spasms  1  0/528 (0.00%)  0 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 1/76 (1.32%)  1 0/32 (0.00%)  0
Osteoarthritis  1  1/528 (0.19%)  1 1/531 (0.19%)  1 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Polyarthritis  1  0/528 (0.00%)  0 1/531 (0.19%)  1 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Spinal stenosis  1  1/528 (0.19%)  1 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Spondylolisthesis  1  1/528 (0.19%)  1 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Invasive breast carcinoma  1  0/528 (0.00%)  0 0/531 (0.00%)  0 0/206 (0.00%)  0 1/74 (1.35%)  1 0/76 (0.00%)  0 0/32 (0.00%)  0
Squamous cell carcinoma  1  1/528 (0.19%)  1 1/531 (0.19%)  1 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Ovarian germ cell teratoma benign  1  0/528 (0.00%)  0 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 1/32 (3.13%)  1
Basal cell carcinoma  1  1/528 (0.19%)  1 2/531 (0.38%)  2 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Benign neoplasm of thyroid gland  1  1/528 (0.19%)  1 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Colon adenoma  1  0/528 (0.00%)  0 1/531 (0.19%)  1 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Colon cancer stage iv  1  1/528 (0.19%)  1 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Endometrial cancer  1  0/528 (0.00%)  0 1/531 (0.19%)  1 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Malignant melanoma in situ  1  2/528 (0.38%)  2 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Neurilemmoma benign  1  1/528 (0.19%)  1 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Prostate cancer  1  1/528 (0.19%)  1 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Prostatic adenoma  1  1/528 (0.19%)  1 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Squamous cell carcinoma of the oral cavity  1  0/528 (0.00%)  0 1/531 (0.19%)  1 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Thymoma  1  1/528 (0.19%)  1 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Uterine leiomyoma  1  0/528 (0.00%)  0 0/531 (0.00%)  0 0/206 (0.00%)  0 1/74 (1.35%)  1 0/76 (0.00%)  0 0/32 (0.00%)  0
Colorectal cancer  1  1/528 (0.19%)  1 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Nervous system disorders             
Cerebrovascular accident  1  1/528 (0.19%)  1 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Cubital tunnel syndrome  1  0/528 (0.00%)  0 1/531 (0.19%)  1 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Dizziness  1  0/528 (0.00%)  0 1/531 (0.19%)  1 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Haemorrhagic stroke  1  0/528 (0.00%)  0 1/531 (0.19%)  1 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Headache  1  0/528 (0.00%)  0 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 1/76 (1.32%)  1 0/32 (0.00%)  0
Idiopathic generalised epilepsy  1  0/528 (0.00%)  0 1/531 (0.19%)  1 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Intracranial aneurysm  1  0/528 (0.00%)  0 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 1/32 (3.13%)  1
Lumbar radiculopathy  1  0/528 (0.00%)  0 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 1/32 (3.13%)  1
Migraine  1  1/528 (0.19%)  1 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 1/76 (1.32%)  1 0/32 (0.00%)  0
Myelopathy  1  1/528 (0.19%)  1 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Ruptured cerebral aneurysm  1  1/528 (0.19%)  1 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Transient ischaemic attack  1  1/528 (0.19%)  1 1/531 (0.19%)  2 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 1/32 (3.13%)  1
Seizure  1  0/528 (0.00%)  0 1/531 (0.19%)  1 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Pregnancy, puerperium and perinatal conditions             
Abortion spontaneous  1  2/528 (0.38%)  2 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Psychiatric disorders             
Disruptive mood dysregulation disorder  1  1/528 (0.19%)  1 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Bipolar disorder  1  1/528 (0.19%)  1 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Renal and urinary disorders             
Acute kidney injury  1  0/528 (0.00%)  0 1/531 (0.19%)  1 1/206 (0.49%)  1 1/74 (1.35%)  1 0/76 (0.00%)  0 0/32 (0.00%)  0
Glomerulonephritis membranous  1  0/528 (0.00%)  0 1/531 (0.19%)  1 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Renal colic  1  0/528 (0.00%)  0 0/531 (0.00%)  0 1/206 (0.49%)  1 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Nephrolithiasis  1  0/528 (0.00%)  0 0/531 (0.00%)  0 0/206 (0.00%)  0 1/74 (1.35%)  1 0/76 (0.00%)  0 0/32 (0.00%)  0
Acute kidney injury  1  1/528 (0.19%)  1 1/531 (0.19%)  1 1/206 (0.49%)  1 1/74 (1.35%)  1 0/76 (0.00%)  0 0/32 (0.00%)  0
Ureterolithiasis  1  1/528 (0.19%)  1 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Reproductive system and breast disorders             
Benign prostatic hyperplasia  1  1/528 (0.19%)  1 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Ovarian cyst  1  0/528 (0.00%)  0 1/531 (0.19%)  1 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Uterine prolapse  1  1/528 (0.19%)  1 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Respiratory, thoracic and mediastinal disorders             
Asthma  1  14/528 (2.65%)  18 41/531 (7.72%)  79 5/206 (2.43%)  6 3/74 (4.05%)  5 8/76 (10.53%)  11 0/32 (0.00%)  0
Asthma  1  16/528 (3.03%)  20 43/531 (8.10%)  91 5/206 (2.43%)  6 5/74 (6.76%)  7 8/76 (10.53%)  12 0/32 (0.00%)  0
Bronchial secretion retention  1  0/528 (0.00%)  0 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 1/76 (1.32%)  1 0/32 (0.00%)  0
Eosinophilic pneumonia  1  0/528 (0.00%)  0 1/531 (0.19%)  1 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Epistaxis  1  0/528 (0.00%)  0 1/531 (0.19%)  1 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Haemothorax  1  1/528 (0.19%)  1 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Nasal polyps  1  0/528 (0.00%)  0 1/531 (0.19%)  1 0/206 (0.00%)  0 0/74 (0.00%)  0 1/76 (1.32%)  1 0/32 (0.00%)  0
Pulmonary embolism  1  1/528 (0.19%)  1 1/531 (0.19%)  1 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Pulmonary sarcoidosis  1  0/528 (0.00%)  0 0/531 (0.00%)  0 1/206 (0.49%)  1 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Skin and subcutaneous tissue disorders             
Dermatitis contact  1  1/528 (0.19%)  1 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Rash  1  0/528 (0.00%)  0 1/531 (0.19%)  1 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Vascular disorders             
Cyanosis  1  1/528 (0.19%)  1 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Haematoma  1  0/528 (0.00%)  0 1/531 (0.19%)  1 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Hypertension  1  0/528 (0.00%)  0 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 1/76 (1.32%)  1 0/32 (0.00%)  0
Peripheral arterial occlusive disease  1  1/528 (0.19%)  1 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Thrombosis  1  1/528 (0.19%)  1 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
1
Term from vocabulary, MedDRA 24.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
NAVIGATOR Rand Teze NAVIGATOR Rand Pbo NAVIGATOR Pbo to Teze SOURCE Rand Teze SOURCE Rand Pbo SOURCE Pbo to Teze
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   390/528 (73.86%)      384/531 (72.32%)      98/206 (47.57%)      53/74 (71.62%)      58/76 (76.32%)      23/32 (71.88%)    
Eye disorders             
Cataract  1  7/528 (1.33%)  8 2/531 (0.38%)  3 0/206 (0.00%)  0 2/74 (2.70%)  2 3/76 (3.95%)  3 1/32 (3.13%)  1
Retinal tear  1  0/528 (0.00%)  0 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 1/32 (3.13%)  1
Gastrointestinal disorders             
Diarrhoea  1  15/528 (2.84%)  15 8/531 (1.51%)  9 2/206 (0.97%)  3 2/74 (2.70%)  2 2/76 (2.63%)  2 1/32 (3.13%)  1
Gastrooesophageal reflux disease  1  9/528 (1.70%)  9 8/531 (1.51%)  9 2/206 (0.97%)  2 3/74 (4.05%)  3 2/76 (2.63%)  3 0/32 (0.00%)  0
Dental caries  1  3/528 (0.57%)  3 6/531 (1.13%)  6 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 1/32 (3.13%)  1
Dyspepsia  1  7/528 (1.33%)  13 4/531 (0.75%)  4 1/206 (0.49%)  2 0/74 (0.00%)  0 0/76 (0.00%)  0 1/32 (3.13%)  1
Nausea  1  16/528 (3.03%)  19 9/531 (1.69%)  10 0/206 (0.00%)  0 1/74 (1.35%)  1 1/76 (1.32%)  1 2/32 (6.25%)  2
General disorders             
Impaired healing  1  0/528 (0.00%)  0 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 1/32 (3.13%)  1
Influenza like illness  1  26/528 (4.92%)  28 25/531 (4.71%)  29 5/206 (2.43%)  6 0/74 (0.00%)  0 6/76 (7.89%)  6 0/32 (0.00%)  0
Pyrexia  1  12/528 (2.27%)  12 9/531 (1.69%)  11 0/206 (0.00%)  0 1/74 (1.35%)  1 0/76 (0.00%)  0 1/32 (3.13%)  1
Hepatobiliary disorders             
Cholelithiasis  1  2/528 (0.38%)  2 1/531 (0.19%)  1 1/206 (0.49%)  1 0/74 (0.00%)  0 0/76 (0.00%)  0 1/32 (3.13%)  1
Immune system disorders             
Hypersensitivity  1  1/528 (0.19%)  1 2/531 (0.38%)  2 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 1/32 (3.13%)  1
Infections and infestations             
Sinusitis  1  30/528 (5.68%)  34 43/531 (8.10%)  64 5/206 (2.43%)  5 2/74 (2.70%)  2 5/76 (6.58%)  6 1/32 (3.13%)  1
Rhinitis  1  18/528 (3.41%)  24 21/531 (3.95%)  42 6/206 (2.91%)  26 4/74 (5.41%)  4 2/76 (2.63%)  2 0/32 (0.00%)  0
Sinusitis bacterial  1  2/528 (0.38%)  2 1/531 (0.19%)  1 1/206 (0.49%)  1 5/74 (6.76%)  5 1/76 (1.32%)  1 0/32 (0.00%)  0
Upper respiratory tract infection bacterial  1  8/528 (1.52%)  10 2/531 (0.38%)  6 1/206 (0.49%)  1 3/74 (4.05%)  3 1/76 (1.32%)  1 0/32 (0.00%)  0
Vaginal infection  1  0/528 (0.00%)  0 3/531 (0.56%)  3 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 1/32 (3.13%)  1
Acute sinusitis  1  16/528 (3.03%)  23 16/531 (3.01%)  26 2/206 (0.97%)  3 0/74 (0.00%)  0 0/76 (0.00%)  0 0/32 (0.00%)  0
Bronchitis bacterial  1  30/528 (5.68%)  34 19/531 (3.58%)  24 3/206 (1.46%)  3 8/74 (10.81%)  20 7/76 (9.21%)  10 3/32 (9.38%)  5
Bronchitis viral  1  2/528 (0.38%)  2 2/531 (0.38%)  2 0/206 (0.00%)  0 0/74 (0.00%)  0 2/76 (2.63%)  3 2/32 (6.25%)  2
Oral candidiasis  1  12/528 (2.27%)  16 15/531 (2.82%)  17 2/206 (0.97%)  2 5/74 (6.76%)  6 6/76 (7.89%)  11 2/32 (6.25%)  2
Pharyngitis  1  26/528 (4.92%)  35 23/531 (4.33%)  28 1/206 (0.49%)  1 0/74 (0.00%)  0 2/76 (2.63%)  2 0/32 (0.00%)  0
Pneumonia haemophilus  1  0/528 (0.00%)  0 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 1/32 (3.13%)  1
Suspected covid-19  1  1/528 (0.19%)  1 1/531 (0.19%)  1 0/206 (0.00%)  0 1/74 (1.35%)  1 0/76 (0.00%)  0 1/32 (3.13%)  1
Tinea versicolour  1  0/528 (0.00%)  0 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 1/32 (3.13%)  1
Upper respiratory tract infection  1  72/528 (13.64%)  131 91/531 (17.14%)  151 6/206 (2.91%)  7 12/74 (16.22%)  13 9/76 (11.84%)  9 0/32 (0.00%)  0
Urinary tract infection  1  29/528 (5.49%)  50 29/531 (5.46%)  33 9/206 (4.37%)  10 1/74 (1.35%)  1 1/76 (1.32%)  2 2/32 (6.25%)  2
Viral rhinitis  1  7/528 (1.33%)  7 4/531 (0.75%)  4 0/206 (0.00%)  0 1/74 (1.35%)  1 0/76 (0.00%)  0 1/32 (3.13%)  1
Viral upper respiratory tract infection  1  24/528 (4.55%)  31 17/531 (3.20%)  23 5/206 (2.43%)  5 2/74 (2.70%)  5 3/76 (3.95%)  3 2/32 (6.25%)  2
Vulval abscess  1  0/528 (0.00%)  0 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 1/32 (3.13%)  1
Bronchitis  1  29/528 (5.49%)  44 39/531 (7.34%)  51 2/206 (0.97%)  2 9/74 (12.16%)  10 3/76 (3.95%)  3 0/32 (0.00%)  0
Covid-19  1  7/528 (1.33%)  8 8/531 (1.51%)  8 10/206 (4.85%)  10 5/74 (6.76%)  5 1/76 (1.32%)  1 4/32 (12.50%)  4
Chronic sinusitis  1  9/528 (1.70%)  13 6/531 (1.13%)  8 1/206 (0.49%)  1 3/74 (4.05%)  4 4/76 (5.26%)  4 0/32 (0.00%)  0
Cystitis  1  8/528 (1.52%)  9 9/531 (1.69%)  11 1/206 (0.49%)  1 0/74 (0.00%)  0 1/76 (1.32%)  2 1/32 (3.13%)  2
Gastroenteritis  1  25/528 (4.73%)  26 16/531 (3.01%)  17 5/206 (2.43%)  5 2/74 (2.70%)  2 1/76 (1.32%)  1 0/32 (0.00%)  0
Lower respiratory tract infection bacterial  1  9/528 (1.70%)  11 8/531 (1.51%)  10 3/206 (1.46%)  4 1/74 (1.35%)  1 1/76 (1.32%)  1 1/32 (3.13%)  2
Nasopharyngitis  1  130/528 (24.62%)  220 124/531 (23.35%)  222 21/206 (10.19%)  26 18/74 (24.32%)  27 22/76 (28.95%)  38 7/32 (21.88%)  12
Otitis media  1  10/528 (1.89%)  12 4/531 (0.75%)  4 2/206 (0.97%)  2 0/74 (0.00%)  0 1/76 (1.32%)  1 1/32 (3.13%)  1
Injury, poisoning and procedural complications             
Traumatic haematoma  1  0/528 (0.00%)  0 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 1/76 (1.32%)  1 1/32 (3.13%)  1
Contusion  1  14/528 (2.65%)  20 9/531 (1.69%)  10 2/206 (0.97%)  2 3/74 (4.05%)  4 1/76 (1.32%)  1 0/32 (0.00%)  0
Facial bones fracture  1  0/528 (0.00%)  0 1/531 (0.19%)  1 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 1/32 (3.13%)  1
Fall  1  9/528 (1.70%)  9 12/531 (2.26%)  12 4/206 (1.94%)  4 3/74 (4.05%)  3 4/76 (5.26%)  4 2/32 (6.25%)  2
Joint dislocation  1  1/528 (0.19%)  1 2/531 (0.38%)  2 1/206 (0.49%)  1 0/74 (0.00%)  0 0/76 (0.00%)  0 1/32 (3.13%)  1
Ligament sprain  1  12/528 (2.27%)  14 9/531 (1.69%)  9 5/206 (2.43%)  5 1/74 (1.35%)  1 1/76 (1.32%)  1 1/32 (3.13%)  1
Metabolism and nutrition disorders             
Hyperlipidaemia  1  4/528 (0.76%)  4 1/531 (0.19%)  1 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 1/32 (3.13%)  1
Type 2 diabetes mellitus  1  16/528 (3.03%)  16 8/531 (1.51%)  9 3/206 (1.46%)  3 1/74 (1.35%)  1 2/76 (2.63%)  2 1/32 (3.13%)  1
Glucose tolerance impaired  1  3/528 (0.57%)  3 2/531 (0.38%)  2 1/206 (0.49%)  1 0/74 (0.00%)  0 0/76 (0.00%)  0 1/32 (3.13%)  1
Hypokalaemia  1  1/528 (0.19%)  1 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 1/32 (3.13%)  1
Musculoskeletal and connective tissue disorders             
Back pain  1  36/528 (6.82%)  49 25/531 (4.71%)  30 5/206 (2.43%)  5 3/74 (4.05%)  4 2/76 (2.63%)  2 0/32 (0.00%)  0
Vertebral foraminal stenosis  1  0/528 (0.00%)  0 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 1/32 (3.13%)  1
Arthralgia  1  27/528 (5.11%)  46 21/531 (3.95%)  23 3/206 (1.46%)  3 2/74 (2.70%)  2 3/76 (3.95%)  4 0/32 (0.00%)  0
Myalgia  1  12/528 (2.27%)  15 11/531 (2.07%)  13 1/206 (0.49%)  1 5/74 (6.76%)  7 1/76 (1.32%)  2 1/32 (3.13%)  1
Pain in extremity  1  18/528 (3.41%)  21 11/531 (2.07%)  12 1/206 (0.49%)  1 2/74 (2.70%)  2 0/76 (0.00%)  0 0/32 (0.00%)  0
Spinal osteoarthritis  1  5/528 (0.95%)  6 3/531 (0.56%)  3 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 1/32 (3.13%)  1
Nervous system disorders             
Hyposmia  1  0/528 (0.00%)  0 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 1/32 (3.13%)  1
Spinal cord disorder  1  0/528 (0.00%)  0 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 1/32 (3.13%)  1
Anosmia  1  0/528 (0.00%)  0 1/531 (0.19%)  1 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 1/32 (3.13%)  1
Cerebral arteriosclerosis  1  0/528 (0.00%)  0 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 1/32 (3.13%)  1
Cerebrovascular disorder  1  0/528 (0.00%)  0 1/531 (0.19%)  1 0/206 (0.00%)  0 0/74 (0.00%)  0 1/76 (1.32%)  1 1/32 (3.13%)  1
Headache  1  58/528 (10.98%)  157 54/531 (10.17%)  101 13/206 (6.31%)  18 9/74 (12.16%)  16 10/76 (13.16%)  12 1/32 (3.13%)  1
Psychiatric disorders             
Anxiety  1  11/528 (2.08%)  13 8/531 (1.51%)  9 5/206 (2.43%)  5 0/74 (0.00%)  0 1/76 (1.32%)  1 1/32 (3.13%)  1
Respiratory, thoracic and mediastinal disorders             
Asthma  1  14/528 (2.65%)  17 25/531 (4.71%)  27 2/206 (0.97%)  3 6/74 (8.11%)  7 9/76 (11.84%)  16 0/32 (0.00%)  0
Nasal polyps  1  0/528 (0.00%)  0 4/531 (0.75%)  6 0/206 (0.00%)  0 1/74 (1.35%)  1 5/76 (6.58%)  7 0/32 (0.00%)  0
Rhinitis allergic  1  30/528 (5.68%)  39 22/531 (4.14%)  31 3/206 (1.46%)  5 0/74 (0.00%)  0 0/76 (0.00%)  0 1/32 (3.13%)  1
Sleep apnoea syndrome  1  5/528 (0.95%)  5 6/531 (1.13%)  6 0/206 (0.00%)  0 1/74 (1.35%)  1 0/76 (0.00%)  0 1/32 (3.13%)  1
Skin and subcutaneous tissue disorders             
Acne  1  4/528 (0.76%)  4 2/531 (0.38%)  2 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 1/32 (3.13%)  1
Dry skin  1  1/528 (0.19%)  1 2/531 (0.38%)  2 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 1/32 (3.13%)  1
Photodermatosis  1  0/528 (0.00%)  0 0/531 (0.00%)  0 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 1/32 (3.13%)  1
Pruritus  1  4/528 (0.76%)  4 9/531 (1.69%)  12 1/206 (0.49%)  2 3/74 (4.05%)  3 0/76 (0.00%)  0 0/32 (0.00%)  0
Rash  1  7/528 (1.33%)  7 7/531 (1.32%)  7 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 2/32 (6.25%)  2
Rash macular  1  0/528 (0.00%)  0 1/531 (0.19%)  1 0/206 (0.00%)  0 0/74 (0.00%)  0 0/76 (0.00%)  0 1/32 (3.13%)  1
Vascular disorders             
Hypertension  1  30/528 (5.68%)  39 26/531 (4.90%)  40 4/206 (1.94%)  4 5/74 (6.76%)  7 7/76 (9.21%)  7 4/32 (12.50%)  4
1
Term from vocabulary, MedDRA 24.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Global Clinical Head
Organization: AstraZeneca
Phone: +1 302 885 1180
EMail: information.center@astrazeneca.com
Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT03706079    
Other Study ID Numbers: D5180C00018
First Submitted: October 11, 2018
First Posted: October 15, 2018
Results First Submitted: October 24, 2022
Results First Posted: February 9, 2023
Last Update Posted: June 6, 2023