Trial Outcomes & Findings for Phase III Double-blind, Placebo-controlled Study of AZD7442 for Post- Exposure Prophylaxis of COVID-19 in Adults (NCT NCT04625972)
NCT ID: NCT04625972
Last Updated: 2023-11-21
Results Overview
To estimate the efficacy of a single IM dose of AZD7442 compared to placebo for the prevention of COVID-19
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1131 participants
Primary outcome timeframe
Planned to be evaluated through Day 183, however, the number of participants required was achieved 127 days after the study start date
Results posted on
2023-11-21
Participant Flow
Target sample size was 1125. As this was a multi-site study there was a lag on the information of the number of participants recruited, hence we ended up with a population slightly over 1125 (N=1131).
Participant milestones
| Measure |
AZD7442
Single dose 300 mg IM (AZD8895 and AZD1061)
|
Placebo
Saline Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
756
|
375
|
|
Overall Study
Dosed (Full Analysis Set)
|
749
|
372
|
|
Overall Study
COMPLETED
|
624
|
304
|
|
Overall Study
NOT COMPLETED
|
132
|
71
|
Reasons for withdrawal
| Measure |
AZD7442
Single dose 300 mg IM (AZD8895 and AZD1061)
|
Placebo
Saline Placebo
|
|---|---|---|
|
Overall Study
Death
|
3
|
2
|
|
Overall Study
Lost to Follow-up
|
82
|
38
|
|
Overall Study
Physician Decision
|
2
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
37
|
24
|
|
Overall Study
Not specified elsewhere
|
8
|
6
|
Baseline Characteristics
Full Analysis Set
Baseline characteristics by cohort
| Measure |
AZD7442
n=749 Participants
Single dose 300 mg IM (AZD8895 and AZD1061)
|
Placebo
n=372 Participants
Saline Placebo
|
Total
n=1121 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.62 Years
STANDARD_DEVIATION 15.74 • n=749 Participants
|
45.97 Years
STANDARD_DEVIATION 16.20 • n=372 Participants
|
46.40 Years
STANDARD_DEVIATION 15.89 • n=1121 Participants
|
|
Age, Customized
|
48.00 Years
n=749 Participants
|
47.00 Years
n=372 Participants
|
48.0 Years
n=1121 Participants
|
|
Sex: Female, Male
Female
|
375 Participants
n=749 Participants • Full Analysis Set
|
182 Participants
n=372 Participants • Full Analysis Set
|
557 Participants
n=1121 Participants • Full Analysis Set
|
|
Sex: Female, Male
Male
|
374 Participants
n=749 Participants • Full Analysis Set
|
190 Participants
n=372 Participants • Full Analysis Set
|
564 Participants
n=1121 Participants • Full Analysis Set
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
6 Participants
n=749 Participants • Full Analysis Set
|
1 Participants
n=372 Participants • Full Analysis Set
|
7 Participants
n=1121 Participants • Full Analysis Set
|
|
Race/Ethnicity, Customized
Asian
|
15 Participants
n=749 Participants • Full Analysis Set
|
13 Participants
n=372 Participants • Full Analysis Set
|
28 Participants
n=1121 Participants • Full Analysis Set
|
|
Race/Ethnicity, Customized
Black or African American
|
76 Participants
n=749 Participants • Full Analysis Set
|
36 Participants
n=372 Participants • Full Analysis Set
|
112 Participants
n=1121 Participants • Full Analysis Set
|
|
Race/Ethnicity, Customized
Multiple
|
4 Participants
n=749 Participants • Full Analysis Set
|
4 Participants
n=372 Participants • Full Analysis Set
|
8 Participants
n=1121 Participants • Full Analysis Set
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=749 Participants • Full Analysis Set
|
1 Participants
n=372 Participants • Full Analysis Set
|
3 Participants
n=1121 Participants • Full Analysis Set
|
|
Race/Ethnicity, Customized
Not reported
|
11 Participants
n=749 Participants • Full Analysis Set
|
1 Participants
n=372 Participants • Full Analysis Set
|
12 Participants
n=1121 Participants • Full Analysis Set
|
|
Race/Ethnicity, Customized
Unknown
|
4 Participants
n=749 Participants • Full Analysis Set
|
2 Participants
n=372 Participants • Full Analysis Set
|
6 Participants
n=1121 Participants • Full Analysis Set
|
|
Race/Ethnicity, Customized
White
|
628 Participants
n=749 Participants • Full Analysis Set
|
314 Participants
n=372 Participants • Full Analysis Set
|
942 Participants
n=1121 Participants • Full Analysis Set
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
435 Participants
n=749 Participants • Full Analysis Set
|
210 Participants
n=372 Participants • Full Analysis Set
|
645 Participants
n=1121 Participants • Full Analysis Set
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
299 Participants
n=749 Participants • Full Analysis Set
|
159 Participants
n=372 Participants • Full Analysis Set
|
458 Participants
n=1121 Participants • Full Analysis Set
|
|
Any COVID-19 comorbidities at baseline
Yes
|
418 Participants
n=749 Participants
|
210 Participants
n=372 Participants
|
628 Participants
n=1121 Participants
|
|
Any COVID-19 comorbidities at baseline
MISSING
|
331 Participants
n=749 Participants
|
162 Participants
n=372 Participants
|
493 Participants
n=1121 Participants
|
|
Any high risk for severe COVID-19 at baseline
Yes
|
486 Participants
n=749 Participants
|
243 Participants
n=372 Participants
|
729 Participants
n=1121 Participants
|
|
Any high risk for severe COVID-19 at baseline
MISSING
|
263 Participants
n=749 Participants
|
129 Participants
n=372 Participants
|
392 Participants
n=1121 Participants
|
|
SARS-CoV-2 status at baseline
Negative
|
651 Participants
n=749 Participants
|
327 Participants
n=372 Participants
|
978 Participants
n=1121 Participants
|
|
SARS-CoV-2 status at baseline
Positive
|
34 Participants
n=749 Participants
|
14 Participants
n=372 Participants
|
48 Participants
n=1121 Participants
|
|
SARS-CoV-2 status at baseline
MISSING
|
64 Participants
n=749 Participants
|
31 Participants
n=372 Participants
|
95 Participants
n=1121 Participants
|
|
Baseline BMI (kg/m^2)
|
29.60 kg/m^2
STANDARD_DEVIATION 6.67 • n=746 Participants • Data has not been recorded for 3 subjects in the AZD7442 arm
|
29.80 kg/m^2
STANDARD_DEVIATION 6.68 • n=372 Participants • Data has not been recorded for 3 subjects in the AZD7442 arm
|
29.67 kg/m^2
STANDARD_DEVIATION 6.67 • n=1118 Participants • Data has not been recorded for 3 subjects in the AZD7442 arm
|
|
Height
|
168.43 cm
STANDARD_DEVIATION 10.56 • n=746 Participants • Data has not been recorded for 3 subjects in the AZD7442 arm
|
168.57 cm
STANDARD_DEVIATION 10.32 • n=372 Participants • Data has not been recorded for 3 subjects in the AZD7442 arm
|
168.5 cm
STANDARD_DEVIATION 10.48 • n=1118 Participants • Data has not been recorded for 3 subjects in the AZD7442 arm
|
PRIMARY outcome
Timeframe: Planned to be evaluated through Day 183, however, the number of participants required was achieved 127 days after the study start datePopulation: All randomized participants who received at least one dose of IMP.
To estimate the efficacy of a single IM dose of AZD7442 compared to placebo for the prevention of COVID-19
Outcome measures
| Measure |
AZD7442
n=749 Participants
Single dose 300 mg IM (AZD8895 and AZD1061)
|
Placebo
n=372 Participants
Saline Placebo
|
|---|---|---|
|
Number of Participants With First Case of SARS-CoV-2 RT-PCR Positive Symptomatic Illness
Primary Analysis
|
23 Participants
|
17 Participants
|
|
Number of Participants With First Case of SARS-CoV-2 RT-PCR Positive Symptomatic Illness
Final analysis
|
28 Participants
|
24 Participants
|
PRIMARY outcome
Timeframe: 457 DaysOutcome measures
| Measure |
AZD7442
n=749 Participants
Single dose 300 mg IM (AZD8895 and AZD1061)
|
Placebo
n=372 Participants
Saline Placebo
|
|---|---|---|
|
AEs, SAEs, MAAEs, and AESIs Post Dose of IMP
Any Adverse Event
|
348 Participants
|
193 Participants
|
|
AEs, SAEs, MAAEs, and AESIs Post Dose of IMP
Non-serious Adverse Event
|
345 Participants
|
191 Participants
|
|
AEs, SAEs, MAAEs, and AESIs Post Dose of IMP
Serious Adverse Events
|
20 Participants
|
16 Participants
|
|
AEs, SAEs, MAAEs, and AESIs Post Dose of IMP
Medically Attended Adverse Events
|
95 Participants
|
52 Participants
|
|
AEs, SAEs, MAAEs, and AESIs Post Dose of IMP
Adverse Events of Special Interest
|
4 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 183 DaysOutcome measures
| Measure |
AZD7442
n=749 Participants
Single dose 300 mg IM (AZD8895 and AZD1061)
|
Placebo
n=372 Participants
Saline Placebo
|
|---|---|---|
|
The Incidence of SARS-CoV-2 RT-PCR-positive Severe or Critical Symptomatic Illness Occurring After Dosing With IMP
Primary analysis
|
0 Participants
|
1 Participants
|
|
The Incidence of SARS-CoV-2 RT-PCR-positive Severe or Critical Symptomatic Illness Occurring After Dosing With IMP
Final Analysis
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 366 DaysOutcome measures
| Measure |
AZD7442
n=570 Participants
Single dose 300 mg IM (AZD8895 and AZD1061)
|
Placebo
n=281 Participants
Saline Placebo
|
|---|---|---|
|
The Incidence of Participants Who Have a Post-treatment Response (Negative at Baseline to Positive at Any Time Post-baseline) for SARSCoV- 2 Nucleocapsid Antibodies
|
173 Participants
|
98 Participants
|
SECONDARY outcome
Timeframe: 366 DaysOutcome measures
| Measure |
AZD7442
n=749 Participants
Single dose 300 mg IM (AZD8895 and AZD1061)
|
Placebo
n=372 Participants
Saline Placebo
|
|---|---|---|
|
The Incidence of COVID-19-related Death Occurring After Dosing With IMP
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 366 DaysOutcome measures
| Measure |
AZD7442
n=749 Participants
Single dose 300 mg IM (AZD8895 and AZD1061)
|
Placebo
n=372 Participants
Saline Placebo
|
|---|---|---|
|
The Incidence of All-cause Mortality Occurring After Dosing With IMP
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 457 DaysPopulation: Only AZD7442 arm samples have been analysed for PK concentrations. Baseline and Day 457 were not calculated due to lot of missing samples or concentrations \< LLOQ
Outcome measures
| Measure |
AZD7442
n=722 Participants
Single dose 300 mg IM (AZD8895 and AZD1061)
|
Placebo
Saline Placebo
|
|---|---|---|
|
Serum AZD7442 Concentrations, PK Parameters
Day 8
|
10.028 µg/mL
Geometric Coefficient of Variation 110.166
|
—
|
|
Serum AZD7442 Concentrations, PK Parameters
Day 29
|
11.718 µg/mL
Geometric Coefficient of Variation 72.721
|
—
|
|
Serum AZD7442 Concentrations, PK Parameters
Day 58
|
9.420 µg/mL
Geometric Coefficient of Variation 75.160
|
—
|
|
Serum AZD7442 Concentrations, PK Parameters
Day 92
|
7.183 µg/mL
Geometric Coefficient of Variation 81.706
|
—
|
|
Serum AZD7442 Concentrations, PK Parameters
Day 183
|
2.975 µg/mL
Geometric Coefficient of Variation 79.694
|
—
|
|
Serum AZD7442 Concentrations, PK Parameters
Day 366
|
0.696 µg/mL
Geometric Coefficient of Variation 63.725
|
—
|
SECONDARY outcome
Timeframe: 457 DaysOutcome measures
| Measure |
AZD7442
n=629 Participants
Single dose 300 mg IM (AZD8895 and AZD1061)
|
Placebo
n=326 Participants
Saline Placebo
|
|---|---|---|
|
Incidence of ADA to AZD7442 in Serum
|
110 Participants
|
6 Participants
|
Adverse Events
AZD7442
Serious events: 20 serious events
Other events: 345 other events
Deaths: 3 deaths
Placebo
Serious events: 16 serious events
Other events: 191 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
AZD7442
n=749 participants at risk
Single dose 300 mg IM (AZD8895 and AZD1061)
|
Placebo
n=372 participants at risk
Saline Placebo
|
|---|---|---|
|
Infections and infestations
Covid-19
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Infections and infestations
Covid-19 pneumonia
|
0.00%
0/749 • 15 months
|
0.81%
3/372 • Number of events 3 • 15 months
|
|
Infections and infestations
Cellulitis
|
0.27%
2/749 • Number of events 2 • 15 months
|
0.00%
0/372 • 15 months
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Infections and infestations
Osteomyelitis
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Infections and infestations
Pneumonia
|
0.40%
3/749 • Number of events 3 • 15 months
|
0.00%
0/372 • 15 months
|
|
Infections and infestations
Pyelonephritis acute
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Cardiac disorders
Cardiac arrest
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Infections and infestations
Urinary tract infection
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Cardiac disorders
Cardiac failure
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Injury, poisoning and procedural complications
Near drowning
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Injury, poisoning and procedural complications
Overdose
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Cardiac disorders
Myocardial infarction
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/749 • 15 months
|
0.54%
2/372 • Number of events 2 • 15 months
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Congenital, familial and genetic disorders
Trisomy 21
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal adenoma
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Nervous system disorders
Basal ganglia haemorrhage
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Nervous system disorders
Cerebral ischaemia
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Nervous system disorders
Multiple sclerosis
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Nervous system disorders
Syncope
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Psychiatric disorders
Bipolar i disorder
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Psychiatric disorders
Suicide attempt
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Renal and urinary disorders
Renal infarct
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Gastrointestinal disorders
Enteritis
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
General disorders
Unevaluable event
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Hepatobiliary disorders
Cholecystitis
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
Other adverse events
| Measure |
AZD7442
n=749 participants at risk
Single dose 300 mg IM (AZD8895 and AZD1061)
|
Placebo
n=372 participants at risk
Saline Placebo
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.27%
2/749 • Number of events 2 • 15 months
|
0.00%
0/372 • 15 months
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Eye disorders
Eye swelling
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Skin and subcutaneous tissue disorders
Cullen's sign
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.54%
2/372 • Number of events 2 • 15 months
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.13%
1/749 • Number of events 4 • 15 months
|
1.1%
4/372 • Number of events 4 • 15 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.40%
3/749 • Number of events 3 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.27%
2/749 • Number of events 2 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Vascular disorders
Accelerated hypertension
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Blood and lymphatic system disorders
Increased tendency to bruise
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Eye disorders
Lacrimation increased
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Vascular disorders
Behcet's syndrome
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Vascular disorders
Deep vein thrombosis
|
0.13%
1/749 • Number of events 2 • 15 months
|
0.00%
0/372 • 15 months
|
|
Vascular disorders
Flushing
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Vascular disorders
Haematoma
|
0.00%
0/749 • 15 months
|
0.54%
2/372 • Number of events 2 • 15 months
|
|
Vascular disorders
Hot flush
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.81%
3/372 • Number of events 3 • 15 months
|
|
Vascular disorders
Hypertension
|
1.5%
11/749 • Number of events 11 • 15 months
|
1.3%
5/372 • Number of events 5 • 15 months
|
|
Vascular disorders
Hypotension
|
0.27%
2/749 • Number of events 2 • 15 months
|
0.00%
0/372 • 15 months
|
|
Vascular disorders
Pallor
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Vascular disorders
Visceral congestion
|
0.00%
0/749 • 15 months
|
0.54%
2/372 • Number of events 2 • 15 months
|
|
Eye disorders
Vision blurred
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Eye disorders
Visual impairment
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.27%
2/749 • Number of events 2 • 15 months
|
0.54%
2/372 • Number of events 2 • 15 months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.27%
2/749 • Number of events 2 • 15 months
|
0.54%
2/372 • Number of events 2 • 15 months
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Gastrointestinal disorders
Constipation
|
0.27%
2/749 • Number of events 2 • 15 months
|
0.54%
2/372 • Number of events 2 • 15 months
|
|
Gastrointestinal disorders
Diarrhoea
|
2.5%
19/749 • Number of events 22 • 15 months
|
6.2%
23/372 • Number of events 28 • 15 months
|
|
Gastrointestinal disorders
Diverticulum
|
0.27%
2/749 • Number of events 2 • 15 months
|
0.00%
0/372 • 15 months
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.27%
2/749 • Number of events 2 • 15 months
|
0.00%
0/372 • 15 months
|
|
Gastrointestinal disorders
Dyspepsia
|
0.53%
4/749 • Number of events 4 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Gastrointestinal disorders
Dysphagia
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Gastrointestinal disorders
Erosive oesophagitis
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Gastrointestinal disorders
Gastritis
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.27%
2/749 • Number of events 2 • 15 months
|
0.00%
0/372 • 15 months
|
|
Gastrointestinal disorders
Gingival swelling
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.27%
2/749 • Number of events 2 • 15 months
|
0.00%
0/372 • 15 months
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.27%
2/749 • Number of events 2 • 15 months
|
0.00%
0/372 • 15 months
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Gastrointestinal disorders
Nausea
|
2.9%
22/749 • Number of events 24 • 15 months
|
6.2%
23/372 • Number of events 26 • 15 months
|
|
Gastrointestinal disorders
Oesophagitis
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Gastrointestinal disorders
Periodontal disease
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Gastrointestinal disorders
Stomach mass
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.27%
2/749 • Number of events 2 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Gastrointestinal disorders
Toothache
|
0.53%
4/749 • Number of events 4 • 15 months
|
0.00%
0/372 • 15 months
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Gastrointestinal disorders
Vomiting
|
1.1%
8/749 • Number of events 10 • 15 months
|
1.9%
7/372 • Number of events 7 • 15 months
|
|
General disorders
Asthenia
|
0.27%
2/749 • Number of events 2 • 15 months
|
0.00%
0/372 • 15 months
|
|
General disorders
Chest discomfort
|
0.27%
2/749 • Number of events 2 • 15 months
|
0.00%
0/372 • 15 months
|
|
General disorders
Chills
|
4.3%
32/749 • Number of events 34 • 15 months
|
6.2%
23/372 • Number of events 26 • 15 months
|
|
General disorders
Drug withdrawal syndrome
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
General disorders
Energy increased
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
General disorders
Fatigue
|
7.6%
57/749 • Number of events 67 • 15 months
|
10.5%
39/372 • Number of events 50 • 15 months
|
|
Blood and lymphatic system disorders
Lymphocytosis
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
General disorders
Feeling abnormal
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
General disorders
Feeling cold
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
General disorders
Generalised oedema
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
General disorders
Impaired healing
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.81%
3/372 • Number of events 4 • 15 months
|
|
Renal and urinary disorders
Pollakiuria
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Renal and urinary disorders
Proteinuria
|
0.67%
5/749 • Number of events 5 • 15 months
|
0.00%
0/372 • 15 months
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Renal and urinary disorders
Urethral stenosis
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Renal and urinary disorders
Urinary bladder polyp
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Endocrine disorders
Hypothyroidism
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Reproductive system and breast disorders
Heavy menstrual bleeding
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Reproductive system and breast disorders
Pelvic congestion
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Respiratory, thoracic and mediastinal disorders
Aphonia
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.7%
80/749 • Number of events 95 • 15 months
|
12.4%
46/372 • Number of events 58 • 15 months
|
|
Eye disorders
Eye movement disorder
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.9%
29/749 • Number of events 33 • 15 months
|
3.8%
14/372 • Number of events 18 • 15 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.53%
4/749 • Number of events 4 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.7%
50/749 • Number of events 64 • 15 months
|
9.1%
34/372 • Number of events 41 • 15 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal obstruction
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.9%
59/749 • Number of events 71 • 15 months
|
7.5%
28/372 • Number of events 34 • 15 months
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus discomfort
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus inflammation
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal erythema
|
0.27%
2/749 • Number of events 2 • 15 months
|
0.54%
2/372 • Number of events 2 • 15 months
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal ulceration
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Eye disorders
Eye pain
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.27%
1/372 • Number of events 2 • 15 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.27%
2/749 • Number of events 2 • 15 months
|
0.54%
2/372 • Number of events 2 • 15 months
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory depression
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.27%
2/749 • Number of events 2 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.40%
3/749 • Number of events 3 • 15 months
|
0.00%
0/372 • 15 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.40%
3/749 • Number of events 3 • 15 months
|
0.00%
0/372 • 15 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
8.1%
61/749 • Number of events 73 • 15 months
|
7.3%
27/372 • Number of events 32 • 15 months
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
1.7%
13/749 • Number of events 16 • 15 months
|
0.81%
3/372 • Number of events 3 • 15 months
|
|
Eye disorders
Eye pruritus
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.40%
3/749 • Number of events 3 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar inflammation
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Psychiatric disorders
Confusional state
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Psychiatric disorders
Depressed mood
|
0.27%
2/749 • Number of events 2 • 15 months
|
0.00%
0/372 • 15 months
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Psychiatric disorders
Depression
|
0.13%
1/749 • Number of events 1 • 15 months
|
1.1%
4/372 • Number of events 4 • 15 months
|
|
Psychiatric disorders
Insomnia
|
0.27%
2/749 • Number of events 2 • 15 months
|
0.00%
0/372 • 15 months
|
|
Psychiatric disorders
Panic attack
|
0.27%
2/749 • Number of events 2 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Psychiatric disorders
Panic disorder
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Renal and urinary disorders
Acute kidney injury
|
0.27%
2/749 • Number of events 2 • 15 months
|
0.54%
2/372 • Number of events 2 • 15 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibrous histiocytoma
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 2 • 15 months
|
|
Renal and urinary disorders
Dysuria
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.54%
2/372 • Number of events 2 • 15 months
|
|
Ear and labyrinth disorders
Middle ear effusion
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Nervous system disorders
Ageusia
|
2.4%
18/749 • Number of events 18 • 15 months
|
3.8%
14/372 • Number of events 14 • 15 months
|
|
Nervous system disorders
Anosmia
|
2.4%
18/749 • Number of events 18 • 15 months
|
3.5%
13/372 • Number of events 13 • 15 months
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Nervous system disorders
Bell's palsy
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Nervous system disorders
Central pain syndrome
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Renal and urinary disorders
Glycosuria
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.54%
2/372 • Number of events 2 • 15 months
|
|
Renal and urinary disorders
Haematuria
|
0.40%
3/749 • Number of events 3 • 15 months
|
0.54%
2/372 • Number of events 2 • 15 months
|
|
Endocrine disorders
Hyperplasia adrenal
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Renal and urinary disorders
Leukocyturia
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Nervous system disorders
Cerebral small vessel ischaemic disease
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Ear and labyrinth disorders
Tympanic membrane disorder
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Nervous system disorders
Dizziness
|
0.53%
4/749 • Number of events 4 • 15 months
|
0.81%
3/372 • Number of events 3 • 15 months
|
|
Nervous system disorders
Dizziness exertional
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Nervous system disorders
Dysgeusia
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Nervous system disorders
Headache
|
11.5%
86/749 • Number of events 109 • 15 months
|
14.0%
52/372 • Number of events 61 • 15 months
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Nervous system disorders
Lacunar infarction
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Nervous system disorders
Lethargy
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Ear and labyrinth disorders
Tympanic membrane hyperaemia
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Nervous system disorders
Migraine
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Nervous system disorders
Neuropathy peripheral
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Nervous system disorders
Presyncope
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Nervous system disorders
Restless legs syndrome
|
0.27%
2/749 • Number of events 2 • 15 months
|
0.00%
0/372 • 15 months
|
|
Nervous system disorders
Sciatica
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Nervous system disorders
Seizure
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Nervous system disorders
Somnolence
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Ear and labyrinth disorders
Vertigo
|
0.40%
3/749 • Number of events 3 • 15 months
|
0.54%
2/372 • Number of events 3 • 15 months
|
|
Nervous system disorders
Syncope
|
0.27%
2/749 • Number of events 2 • 15 months
|
0.54%
2/372 • Number of events 2 • 15 months
|
|
Nervous system disorders
Tremor
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Psychiatric disorders
Adjustment disorder
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Psychiatric disorders
Adjustment disorder with depressed mood
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Psychiatric disorders
Anxiety
|
0.80%
6/749 • Number of events 6 • 15 months
|
0.54%
2/372 • Number of events 2 • 15 months
|
|
Psychiatric disorders
Attention deficit hyperactivity disorder
|
0.40%
3/749 • Number of events 3 • 15 months
|
0.00%
0/372 • 15 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.27%
2/749 • Number of events 2 • 15 months
|
0.00%
0/372 • 15 months
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Immune system disorders
Allergy to arthropod sting
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Immune system disorders
Drug hypersensitivity
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Immune system disorders
Hypersensitivity
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Immune system disorders
Mycotic allergy
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Immune system disorders
Seasonal allergy
|
0.27%
2/749 • Number of events 2 • 15 months
|
0.54%
2/372 • Number of events 2 • 15 months
|
|
Infections and infestations
Abscess
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Infections and infestations
Abscess limb
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Infections and infestations
Acute sinusitis
|
0.40%
3/749 • Number of events 3 • 15 months
|
0.00%
0/372 • 15 months
|
|
Blood and lymphatic system disorders
Normocytic anaemia
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Infections and infestations
Appendicitis
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Infections and infestations
Asymptomatic covid-19
|
0.93%
7/749 • Number of events 7 • 15 months
|
1.3%
5/372 • Number of events 5 • 15 months
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Infections and infestations
Bacterial vaginosis
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Infections and infestations
Bacterial vulvovaginitis
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Infections and infestations
Bacteriuria
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Infections and infestations
Bronchitis
|
0.80%
6/749 • Number of events 6 • 15 months
|
0.81%
3/372 • Number of events 3 • 15 months
|
|
Infections and infestations
Covid-19
|
15.6%
117/749 • Number of events 125 • 15 months
|
14.2%
53/372 • Number of events 54 • 15 months
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Infections and infestations
Cellulitis
|
0.40%
3/749 • Number of events 4 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Infections and infestations
Diarrhoea infectious
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Infections and infestations
Diverticulitis
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Infections and infestations
Ear infection
|
0.27%
2/749 • Number of events 2 • 15 months
|
0.54%
2/372 • Number of events 2 • 15 months
|
|
Infections and infestations
Epstein-barr virus infection
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Infections and infestations
Eye infection
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Infections and infestations
Fungal skin infection
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Infections and infestations
Furuncle
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Infections and infestations
Gastroenteritis
|
0.27%
2/749 • Number of events 2 • 15 months
|
0.54%
2/372 • Number of events 2 • 15 months
|
|
Infections and infestations
Gastroenteritis viral
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
0.27%
2/749 • Number of events 2 • 15 months
|
0.00%
0/372 • 15 months
|
|
Infections and infestations
Herpes zoster
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Infections and infestations
Hordeolum
|
0.13%
1/749 • Number of events 2 • 15 months
|
0.00%
0/372 • 15 months
|
|
Infections and infestations
Influenza
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Infections and infestations
Labyrinthitis
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 2 • 15 months
|
|
Infections and infestations
Localised infection
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Infections and infestations
Lower respiratory tract infection
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Infections and infestations
Myringitis
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Infections and infestations
Nasopharyngitis
|
2.1%
16/749 • Number of events 17 • 15 months
|
1.1%
4/372 • Number of events 6 • 15 months
|
|
Cardiac disorders
Angina pectoris
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Infections and infestations
Onychomycosis
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Infections and infestations
Oral herpes
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Infections and infestations
Otitis externa
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Infections and infestations
Otitis media
|
0.53%
4/749 • Number of events 4 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Infections and infestations
Periorbital cellulitis
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Infections and infestations
Pharyngitis
|
0.27%
2/749 • Number of events 2 • 15 months
|
0.54%
2/372 • Number of events 2 • 15 months
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.40%
3/749 • Number of events 3 • 15 months
|
0.54%
2/372 • Number of events 2 • 15 months
|
|
Infections and infestations
Pilonidal cyst
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Infections and infestations
Pneumonia
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Cardiac disorders
Atrioventricular block complete
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Infections and infestations
Post procedural infection
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Infections and infestations
Pyelonephritis
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.27%
2/749 • Number of events 2 • 15 months
|
0.00%
0/372 • 15 months
|
|
Infections and infestations
Respiratory tract infection
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Infections and infestations
Rhinitis
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.54%
2/372 • Number of events 2 • 15 months
|
|
Infections and infestations
Sepsis
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Infections and infestations
Sinusitis
|
0.93%
7/749 • Number of events 7 • 15 months
|
1.1%
4/372 • Number of events 5 • 15 months
|
|
Infections and infestations
Sinusitis bacterial
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Infections and infestations
Skin infection
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Infections and infestations
Superinfection bacterial
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Infections and infestations
Suspected covid-19
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Infections and infestations
Tonsillitis
|
0.27%
2/749 • Number of events 2 • 15 months
|
0.00%
0/372 • 15 months
|
|
Infections and infestations
Tooth abscess
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Infections and infestations
Tooth infection
|
0.13%
1/749 • Number of events 2 • 15 months
|
0.00%
0/372 • 15 months
|
|
Infections and infestations
Upper respiratory tract infection
|
1.9%
14/749 • Number of events 14 • 15 months
|
0.81%
3/372 • Number of events 3 • 15 months
|
|
Infections and infestations
Urinary tract infection
|
2.9%
22/749 • Number of events 24 • 15 months
|
3.5%
13/372 • Number of events 15 • 15 months
|
|
Infections and infestations
Vaginal infection
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Infections and infestations
Viral infection
|
0.27%
2/749 • Number of events 2 • 15 months
|
0.00%
0/372 • 15 months
|
|
Infections and infestations
Wound infection
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/749 • 15 months
|
0.54%
2/372 • Number of events 2 • 15 months
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Injury, poisoning and procedural complications
Back injury
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Injury, poisoning and procedural complications
Bone contusion
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Injury, poisoning and procedural complications
Concussion
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Injury, poisoning and procedural complications
Contusion
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.81%
3/372 • Number of events 5 • 15 months
|
|
Injury, poisoning and procedural complications
Exposure to toxic agent
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Injury, poisoning and procedural complications
Face injury
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Cardiac disorders
Cardiac failure chronic
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Injury, poisoning and procedural complications
Fall
|
0.67%
5/749 • Number of events 7 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/749 • 15 months
|
0.54%
2/372 • Number of events 2 • 15 months
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.27%
2/749 • Number of events 2 • 15 months
|
0.54%
2/372 • Number of events 2 • 15 months
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Injury, poisoning and procedural complications
Neck injury
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Cardiac disorders
Chronic left ventricular failure
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.27%
2/749 • Number of events 2 • 15 months
|
0.00%
0/372 • 15 months
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.54%
2/372 • Number of events 2 • 15 months
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Blood and lymphatic system disorders
Anaemia
|
0.67%
5/749 • Number of events 6 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Injury, poisoning and procedural complications
Traumatic haemorrhage
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.27%
2/749 • Number of events 2 • 15 months
|
0.00%
0/372 • 15 months
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
0.53%
4/749 • Number of events 7 • 15 months
|
1.3%
5/372 • Number of events 12 • 15 months
|
|
Investigations
Alanine aminotransferase abnormal
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Investigations
Alanine aminotransferase increased
|
0.13%
1/749 • Number of events 1 • 15 months
|
1.3%
5/372 • Number of events 5 • 15 months
|
|
Investigations
Aspartate aminotransferase abnormal
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Investigations
Aspartate aminotransferase increased
|
0.67%
5/749 • Number of events 5 • 15 months
|
1.1%
4/372 • Number of events 4 • 15 months
|
|
Investigations
Blood cholesterol increased
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Investigations
Blood creatine increased
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Investigations
Blood creatine phosphokinase increased
|
1.6%
12/749 • Number of events 15 • 15 months
|
1.1%
4/372 • Number of events 4 • 15 months
|
|
Investigations
Blood creatinine increased
|
0.27%
2/749 • Number of events 3 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Investigations
Blood glucose increased
|
0.67%
5/749 • Number of events 5 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Investigations
Blood iron decreased
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Investigations
Blood phosphorus decreased
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Investigations
Blood potassium decreased
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Cardiac disorders
Palpitations
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Investigations
Blood potassium increased
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Investigations
Blood pressure diastolic increased
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Investigations
Blood pressure increased
|
0.40%
3/749 • Number of events 3 • 15 months
|
0.54%
2/372 • Number of events 2 • 15 months
|
|
Investigations
Blood uric acid increased
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Investigations
Body temperature increased
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Investigations
C-reactive protein increased
|
1.2%
9/749 • Number of events 10 • 15 months
|
0.81%
3/372 • Number of events 3 • 15 months
|
|
Investigations
Electrocardiogram t wave inversion
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.1%
8/749 • Number of events 8 • 15 months
|
1.1%
4/372 • Number of events 4 • 15 months
|
|
Investigations
Glomerular filtration rate decreased
|
0.27%
2/749 • Number of events 2 • 15 months
|
0.54%
2/372 • Number of events 2 • 15 months
|
|
Investigations
Haematocrit decreased
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Investigations
Haemoglobin decreased
|
0.27%
2/749 • Number of events 2 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Investigations
Hepatic enzyme increased
|
0.27%
2/749 • Number of events 2 • 15 months
|
0.00%
0/372 • 15 months
|
|
Investigations
Influenza a virus test positive
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Investigations
Liver function test abnormal
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Investigations
Liver function test increased
|
0.27%
2/749 • Number of events 2 • 15 months
|
0.00%
0/372 • 15 months
|
|
Investigations
Lymph node palpable
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Investigations
Neutrophil count increased
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Investigations
Platelet count decreased
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Investigations
Red blood cell count decreased
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Investigations
Red blood cells urine
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/749 • 15 months
|
0.81%
3/372 • Number of events 3 • 15 months
|
|
Investigations
Red blood cells urine positive
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Investigations
Urine analysis abnormal
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Investigations
Weight decreased
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Investigations
White blood cell count increased
|
0.40%
3/749 • Number of events 3 • 15 months
|
0.00%
0/372 • 15 months
|
|
Investigations
White blood cells urine positive
|
0.53%
4/749 • Number of events 4 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.53%
4/749 • Number of events 4 • 15 months
|
1.3%
5/372 • Number of events 5 • 15 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.53%
4/749 • Number of events 4 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.40%
3/749 • Number of events 3 • 15 months
|
0.81%
3/372 • Number of events 3 • 15 months
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Cardiac disorders
Ventricular hypokinesia
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/749 • 15 months
|
0.54%
2/372 • Number of events 2 • 15 months
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.27%
2/749 • Number of events 2 • 15 months
|
0.00%
0/372 • 15 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.40%
3/749 • Number of events 3 • 15 months
|
1.1%
4/372 • Number of events 4 • 15 months
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.27%
2/749 • Number of events 2 • 15 months
|
0.54%
2/372 • Number of events 2 • 15 months
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.27%
2/749 • Number of events 2 • 15 months
|
0.54%
2/372 • Number of events 2 • 15 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.40%
3/749 • Number of events 4 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.54%
2/372 • Number of events 2 • 15 months
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.53%
4/749 • Number of events 4 • 15 months
|
0.54%
2/372 • Number of events 2 • 15 months
|
|
Metabolism and nutrition disorders
Vitamin b12 deficiency
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.6%
12/749 • Number of events 13 • 15 months
|
0.54%
2/372 • Number of events 2 • 15 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.3%
10/749 • Number of events 12 • 15 months
|
1.9%
7/372 • Number of events 7 • 15 months
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.27%
2/749 • Number of events 3 • 15 months
|
0.00%
0/372 • 15 months
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 2 • 15 months
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.53%
4/749 • Number of events 4 • 15 months
|
0.00%
0/372 • 15 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.54%
2/372 • Number of events 3 • 15 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.3%
25/749 • Number of events 29 • 15 months
|
7.3%
27/372 • Number of events 30 • 15 months
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.54%
2/372 • Number of events 2 • 15 months
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.67%
5/749 • Number of events 5 • 15 months
|
1.3%
5/372 • Number of events 5 • 15 months
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Ear and labyrinth disorders
Ear pain
|
0.40%
3/749 • Number of events 3 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.27%
2/749 • Number of events 2 • 15 months
|
0.00%
0/372 • 15 months
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Musculoskeletal and connective tissue disorders
Seronegative arthritis
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
General disorders
Influenza like illness
|
0.53%
4/749 • Number of events 4 • 15 months
|
0.54%
2/372 • Number of events 3 • 15 months
|
|
General disorders
Injection site pain
|
0.40%
3/749 • Number of events 3 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
General disorders
Injection site pruritus
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.54%
2/372 • Number of events 2 • 15 months
|
|
General disorders
Injection site reaction
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
General disorders
Localised oedema
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
General disorders
Malaise
|
0.93%
7/749 • Number of events 7 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Blood and lymphatic system disorders
Monocytosis
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
General disorders
Non-cardiac chest pain
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.00%
0/372 • 15 months
|
|
General disorders
Pain
|
5.2%
39/749 • Number of events 44 • 15 months
|
9.4%
35/372 • Number of events 40 • 15 months
|
|
General disorders
Pyrexia
|
6.1%
46/749 • Number of events 57 • 15 months
|
8.6%
32/372 • Number of events 34 • 15 months
|
|
General disorders
Swelling
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
General disorders
Thirst
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
General disorders
Vaccination site pain
|
0.13%
1/749 • Number of events 1 • 15 months
|
0.54%
2/372 • Number of events 2 • 15 months
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
|
Hepatobiliary disorders
Gallbladder polyp
|
0.00%
0/749 • 15 months
|
0.27%
1/372 • Number of events 1 • 15 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60