Trial Outcomes & Findings for Childhood Adenotonsillectomy Study for Children With OSAS (NCT NCT00560859)
NCT ID: NCT00560859
Last Updated: 2015-12-15
Results Overview
The primary outcome was the change in the attention and executive function score on the NEPSY. The change from baseline in Attention/Executive Domain Index of the Developmental Neuropsychological Assessment (NEPSY) was compared to 7 months were compared. Scores on the attention and executive-function domain of the Developmental Neuropsychological Assessment (NEPSY) range from 50 to 150, with higher scores indicating better functioning.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
453 participants
Primary outcome timeframe
The primary endpoint measure will occur at 7 months following the baseline visit.
Results posted on
2015-12-15
Participant Flow
Children were recruited at 7 academic sleep centers. Early in the trial the investigator at one center relocated and that center was withdrawn.
Participant milestones
| Measure |
Early AT Surgery
Adenotonsillectomy (AT) - removal of tonsils and adenoids - performed within 4 weeks of the baseline visit.
Adenotonsillectomy (AT) - removal of adenoids and tonsils: Standard surgical intervention for treatment of Obstructive Sleep Apnea Syndrome.
|
Watchful Waiting
Children will be closely monitored during the primary 7 month monitoring period and will be re-evaluated for AT by an otolaryngologist at the end of that period. a
Watchful Waiting: Children will reevaluated for adenotonsillectomy (AT) after a 7 month primary monitoring period.
|
|---|---|---|
|
Overall Study
STARTED
|
226
|
227
|
|
Overall Study
COMPLETED
|
194
|
203
|
|
Overall Study
NOT COMPLETED
|
32
|
24
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Childhood Adenotonsillectomy Study for Children With OSAS
Baseline characteristics by cohort
| Measure |
Early AT Surgery
n=226 Participants
Adenotonsillectomy (AT) - removal of tonsils and adenoids - performed within 4 weeks of the baseline visit.
Adenotonsillectomy (AT) - removal of adenoids and tonsils: Standard surgical intervention for treatment of Obstructive Sleep Apnea Syndrome.
|
Watchful Waiting
n=227 Participants
Children will be closely monitored and re-evaluated for AT by an otolaryngologist after the primary 7 month monitoring period.
Watchful Waiting: Children will reevaluated for adenotonsillectomy (AT) after a 7 month primary monitoring period.
|
Total
n=453 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
6.6 Years
STANDARD_DEVIATION 1.4 • n=5 Participants
|
6.5 Years
STANDARD_DEVIATION 1.4 • n=7 Participants
|
6.6 Years
STANDARD_DEVIATION 1.4 • n=5 Participants
|
|
Age, Categorical
<=18 years
|
226 Participants
n=5 Participants
|
227 Participants
n=7 Participants
|
453 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
125 Participants
n=5 Participants
|
109 Participants
n=7 Participants
|
234 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
101 Participants
n=5 Participants
|
118 Participants
n=7 Participants
|
219 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
126 Participants
n=5 Participants
|
123 Participants
n=7 Participants
|
249 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
74 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
155 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
15 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
16 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
210 Participants
n=5 Participants
|
206 Participants
n=7 Participants
|
416 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
226 participants
n=5 Participants
|
227 participants
n=7 Participants
|
453 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: The primary endpoint measure will occur at 7 months following the baseline visit.The primary outcome was the change in the attention and executive function score on the NEPSY. The change from baseline in Attention/Executive Domain Index of the Developmental Neuropsychological Assessment (NEPSY) was compared to 7 months were compared. Scores on the attention and executive-function domain of the Developmental Neuropsychological Assessment (NEPSY) range from 50 to 150, with higher scores indicating better functioning.
Outcome measures
| Measure |
Early AT Surgery
n=194 Participants
Adenotonsillectomy (AT) - removal of tonsils and adenoids - performed within 4 weeks of the baseline visit.
Adenotonsillectomy (AT) - removal of adenoids and tonsils: Standard surgical intervention for treatment of Obstructive Sleep Apnea Syndrome.
|
Watchful Waiting
n=203 Participants
Children will be closely monitored during the primary 7-month monitoring period and re-evaluated for AT by an otolaryngologist after that period.
Watchful Waiting: Children will reevaluated for adenotonsillectomy (AT) after a 7 month primary monitoring period.
|
|---|---|---|
|
Improvements in Attention/Executive Domain Index of the Developmental Neuropsychological Assessment (NEPSY) From Baseline to 7 Months.
|
7.1 units on a scale
Standard Deviation 13.9
|
5.1 units on a scale
Standard Deviation 13.4
|
SECONDARY outcome
Timeframe: 7 months following the baseline visit.The outcome measure was the change in AHI from baseline to 7 months to determine if there was an improvement in score is associated with improved OSAS (i.e reduction in AHI). The AHI is calculated by dividing the number of apnea events by the number of hours of sleep. The obstructive sleep apnea syndrome was defined as an AHI score of 2 or more events per hour or an obstructive apnea index (OAI) score of 1 or more events per hour.
Outcome measures
| Measure |
Early AT Surgery
n=194 Participants
Adenotonsillectomy (AT) - removal of tonsils and adenoids - performed within 4 weeks of the baseline visit.
Adenotonsillectomy (AT) - removal of adenoids and tonsils: Standard surgical intervention for treatment of Obstructive Sleep Apnea Syndrome.
|
Watchful Waiting
n=203 Participants
Children will be closely monitored during the primary 7-month monitoring period and re-evaluated for AT by an otolaryngologist after that period.
Watchful Waiting: Children will reevaluated for adenotonsillectomy (AT) after a 7 month primary monitoring period.
|
|---|---|---|
|
Change in Apnea Hypopnea Index (AHI) Score From Baseline to 7 Months
|
-3.5 Events per hour
Interval -7.1 to -1.8
|
-1.6 Events per hour
Interval -3.7 to 0.5
|
SECONDARY outcome
Timeframe: 7 months following baseline.Population: There was missing data for some children in the Watchful Waiting group since the Pediatric Sleep Questionnaire was not completed. Hence these numbers are not consistent with the rows in the participant flow module
Scores on the Pediatric Sleep Questionnaire sleep-related breathing disorder scale (PSQ-SRBD) range from 0 to 1, with higher scores indicating greater severity.
Outcome measures
| Measure |
Early AT Surgery
n=194 Participants
Adenotonsillectomy (AT) - removal of tonsils and adenoids - performed within 4 weeks of the baseline visit.
Adenotonsillectomy (AT) - removal of adenoids and tonsils: Standard surgical intervention for treatment of Obstructive Sleep Apnea Syndrome.
|
Watchful Waiting
n=202 Participants
Children will be closely monitored during the primary 7-month monitoring period and re-evaluated for AT by an otolaryngologist after that period.
Watchful Waiting: Children will reevaluated for adenotonsillectomy (AT) after a 7 month primary monitoring period.
|
|---|---|---|
|
Change in Score of Pediatric Sleep Questionnaire Sleep-related Breathing Disorder Scale
|
-0.3 units on a scale
Standard Deviation 0.2
|
0 units on a scale
Standard Deviation 0.2
|
Adverse Events
Early AT Surgery
Serious events: 7 serious events
Other events: 166 other events
Deaths: 0 deaths
Watchful Waiting
Serious events: 9 serious events
Other events: 227 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Early AT Surgery
n=226 participants at risk
Adenotonsillectomy (AT) - removal of tonsils and adenoids - performed within 4 weeks of the baseline visit.
Adenotonsillectomy (AT) - removal of adenoids and tonsils: Standard surgical intervention for treatment of Obstructive Sleep Apnea Syndrome.
|
Watchful Waiting
n=227 participants at risk
Children will be closely monitored and re-evaluated for AT by an otolaryngologist after the primary 7 month monitoring period.
Watchful Waiting: Children will reevaluated for adenotonsillectomy (AT) after a 7 month primary monitoring period.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.44%
1/226 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
1.3%
3/227 • Number of events 3 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
General disorders
Application site pain
|
0.44%
1/226 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.44%
1/227 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.44%
1/226 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.00%
0/227 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion (non-malignant)
|
0.44%
1/226 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.00%
0/227 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar haemorrhage
|
1.3%
3/226 • Number of events 3 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.44%
1/227 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/226 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.44%
1/227 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Vascular disorders
Hypertension
|
0.00%
0/226 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.44%
1/227 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
0.00%
0/226 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.44%
1/227 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Gastrointestinal disorders
Vomitting
|
0.00%
0/226 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.44%
1/227 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
Other adverse events
| Measure |
Early AT Surgery
n=226 participants at risk
Adenotonsillectomy (AT) - removal of tonsils and adenoids - performed within 4 weeks of the baseline visit.
Adenotonsillectomy (AT) - removal of adenoids and tonsils: Standard surgical intervention for treatment of Obstructive Sleep Apnea Syndrome.
|
Watchful Waiting
n=227 participants at risk
Children will be closely monitored and re-evaluated for AT by an otolaryngologist after the primary 7 month monitoring period.
Watchful Waiting: Children will reevaluated for adenotonsillectomy (AT) after a 7 month primary monitoring period.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
0.44%
1/226 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.00%
0/227 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
General disorders
Application site bleeding
|
0.44%
1/226 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.00%
0/227 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
General disorders
Application site rash
|
0.44%
1/226 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.00%
0/227 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.88%
2/226 • Number of events 2 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
6.2%
14/227 • Number of events 14 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Asthmatic crisis
|
0.00%
0/226 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.44%
1/227 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Psychiatric disorders
Attention Deficit/Hyperactivitiy disorder
|
1.3%
3/226 • Number of events 3 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
1.8%
4/227 • Number of events 4 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/226 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.44%
1/227 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Investigations
Blood Glucose
|
0.00%
0/226 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.44%
1/227 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Infections and infestations
Body Tinea
|
0.44%
1/226 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.44%
1/227 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Gastrointestinal disorders
Breath Odor
|
0.44%
1/226 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.00%
0/227 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Infections and infestations
Bronchitis
|
0.44%
1/226 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
1.3%
3/227 • Number of events 3 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/226 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.44%
1/227 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Choking sensation
|
0.44%
1/226 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.00%
0/227 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Eye disorders
Conjuctivits
|
0.88%
2/226 • Number of events 2 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.44%
1/227 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Gastrointestinal disorders
Constipation
|
0.44%
1/226 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.00%
0/227 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.6%
15/226 • Number of events 15 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
4.8%
11/227 • Number of events 11 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Infections and infestations
Croup Infectious
|
0.00%
0/226 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.44%
1/227 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Croup Non infectious
|
0.44%
1/226 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.00%
0/227 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.3%
3/226 • Number of events 3 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.44%
1/227 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.44%
1/226 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.00%
0/227 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Metabolism and nutrition disorders
Diabetes Mellitus non-insulin dependent
|
0.44%
1/226 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.00%
0/227 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/226 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.44%
1/227 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Gastrointestinal disorders
Dysphagia
|
0.44%
1/226 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.00%
0/227 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Infections and infestations
Ear Infection
|
1.8%
4/226 • Number of events 4 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
3.5%
8/227 • Number of events 8 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Infections and infestations
Ear Infection Baceterial
|
3.1%
7/226 • Number of events 7 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
1.8%
4/227 • Number of events 4 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Ear and labyrinth disorders
Ear Pain
|
1.3%
3/226 • Number of events 3 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.88%
2/227 • Number of events 2 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Social circumstances
Ear Piercing
|
0.44%
1/226 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.00%
0/227 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Surgical and medical procedures
Ear Tube removal
|
0.00%
0/226 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.44%
1/227 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Investigations
electroencephalogram abnormal
|
0.44%
1/226 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.44%
1/227 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Investigations
Emergency care examination normal
|
0.44%
1/226 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.00%
0/227 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Renal and urinary disorders
Enuresis
|
0.00%
0/226 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.44%
1/227 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.88%
2/226 • Number of events 2 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
1.8%
4/227 • Number of events 4 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Ear and labyrinth disorders
External ear infection
|
0.44%
1/226 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.00%
0/227 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Eye disorders
Eye Allergy
|
0.44%
1/226 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.00%
0/227 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/226 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.44%
1/227 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
General disorders
fatigue
|
0.00%
0/226 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.44%
1/227 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Infections and infestations
Febrile infection
|
0.88%
2/226 • Number of events 2 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.44%
1/227 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
General disorders
fever (in the absence of neutropenia, where neutropenia is defined as anc <1.0 x 10e9/l)
|
0.00%
0/226 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.44%
1/227 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Surgical and medical procedures
Finger nail removal
|
0.00%
0/226 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.44%
1/227 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Injury, poisoning and procedural complications
Foreign body in eye
|
0.00%
0/226 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.44%
1/227 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/226 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.44%
1/227 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Infections and infestations
Gastroenteritis
|
0.88%
2/226 • Number of events 2 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.00%
0/227 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Infections and infestations
Gastroenteritis adenovirus
|
0.00%
0/226 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.44%
1/227 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Infections and infestations
gastroenteritis viral
|
0.44%
1/226 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
1.8%
4/227 • Number of events 4 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Gastrointestinal disorders
gastrooesophageal reflux disease
|
0.88%
2/226 • Number of events 2 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.00%
0/227 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Reproductive system and breast disorders
genital rash
|
0.00%
0/226 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.44%
1/227 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Musculoskeletal and connective tissue disorders
Growing pains
|
0.44%
1/226 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.00%
0/227 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Injury, poisoning and procedural complications
hand fracture
|
0.44%
1/226 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.44%
1/227 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
0.44%
1/226 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.44%
1/227 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Injury, poisoning and procedural complications
head injury
|
0.44%
1/226 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.00%
0/227 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Nervous system disorders
headache
|
0.44%
1/226 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
2.6%
6/227 • Number of events 6 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Investigations
Heart rate irregular
|
0.00%
0/226 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.44%
1/227 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Infections and infestations
hordeolum
|
0.00%
0/226 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.44%
1/227 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Nervous system disorders
hypersomnia
|
0.44%
1/226 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.00%
0/227 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Injury, poisoning and procedural complications
incision site pain
|
0.88%
2/226 • Number of events 2 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.00%
0/227 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Infections and infestations
infected insect bite
|
0.88%
2/226 • Number of events 2 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.44%
1/227 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Injury, poisoning and procedural complications
infection with unknown anc - bladder (urinary)
|
0.00%
0/226 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.44%
1/227 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Infections and infestations
influenza
|
0.88%
2/226 • Number of events 2 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
1.3%
3/227 • Number of events 3 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
General disorders
influenza like illness
|
0.00%
0/226 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
1.8%
4/227 • Number of events 4 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Injury, poisoning and procedural complications
laceration
|
0.00%
0/226 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.88%
2/227 • Number of events 2 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Infections and infestations
Lice infestation
|
0.00%
0/226 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.44%
1/227 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Nervous system disorders
loss of consciousness
|
0.44%
1/226 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.00%
0/227 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Immune system disorders
multiple allergies
|
0.00%
0/226 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.44%
1/227 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Injury, poisoning and procedural complications
muscle injury
|
0.88%
2/226 • Number of events 2 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.00%
0/227 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Infections and infestations
Nail Tinea
|
0.44%
1/226 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.00%
0/227 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Injury, poisoning and procedural complications
nasal cavity/paranasal sinus reactions
|
0.00%
0/226 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.88%
2/227 • Number of events 2 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
nasal congestion
|
4.4%
10/226 • Number of events 10 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
4.4%
10/227 • Number of events 10 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Infections and infestations
nasopharyngitis
|
0.00%
0/226 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.44%
1/227 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/226 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.44%
1/227 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Musculoskeletal and connective tissue disorders
neck pain
|
0.00%
0/226 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.44%
1/227 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Infections and infestations
Otitis media
|
2.7%
6/226 • Number of events 6 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
1.8%
4/227 • Number of events 4 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Infections and infestations
Otitis media bacterial
|
0.00%
0/226 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.44%
1/227 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Surgical and medical procedures
pain management
|
0.44%
1/226 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.00%
0/227 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Infections and infestations
Pharyngitis
|
1.8%
4/226 • Number of events 4 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
3.1%
7/227 • Number of events 7 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Infections and infestations
pharyngitis streptococcal
|
0.88%
2/226 • Number of events 2 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
2.2%
5/227 • Number of events 5 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Infections and infestations
pneumonia
|
1.8%
4/226 • Number of events 4 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.88%
2/227 • Number of events 2 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Infections and infestations
pneumonia mycoplasmal
|
0.44%
1/226 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.44%
1/227 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Injury, poisoning and procedural complications
post procedural complication
|
0.44%
1/226 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.00%
0/227 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
postnasal drip
|
0.44%
1/226 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.00%
0/227 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Injury, poisoning and procedural complications
postoperative fever
|
0.44%
1/226 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.00%
0/227 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Endocrine disorders
precocious puberty
|
0.44%
1/226 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.00%
0/227 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
productive cough
|
0.44%
1/226 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.00%
0/227 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary congestion
|
0.44%
1/226 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.00%
0/227 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
General disorders
pyrexia
|
0.44%
1/226 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.00%
0/227 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Skin and subcutaneous tissue disorders
rash
|
0.88%
2/226 • Number of events 2 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.44%
1/227 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Infections and infestations
relapsing fever
|
0.44%
1/226 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.00%
0/227 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/226 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.88%
2/227 • Number of events 2 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis seasonal
|
0.00%
0/226 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.88%
2/227 • Number of events 2 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/226 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.44%
1/227 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/226 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.44%
1/227 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Injury, poisoning and procedural complications
road traffic accident
|
0.44%
1/226 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.00%
0/227 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Infections and infestations
Scarlet Fever
|
0.00%
0/226 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.88%
2/227 • Number of events 2 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Immune system disorders
Seasonal Allergy
|
0.88%
2/226 • Number of events 2 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
1.8%
4/227 • Number of events 4 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.44%
1/226 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.44%
1/227 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/226 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.44%
1/227 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Infections and infestations
Sinusitis
|
0.44%
1/226 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.00%
0/227 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Infections and infestations
Sinusitis bacterial
|
0.00%
0/226 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.44%
1/227 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/226 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.88%
2/227 • Number of events 2 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep Apnea
|
0.00%
0/226 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
2.2%
5/227 • Number of events 5 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Snoring
|
0.00%
0/226 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.44%
1/227 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/226 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.44%
1/227 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Infections and infestations
Staphylococcal skin infection
|
0.44%
1/226 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.00%
0/227 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Gastrointestinal disorders
Stomach discomfort
|
0.00%
0/226 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.88%
2/227 • Number of events 2 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Infections and infestations
Streptococcal bacteraemia
|
1.8%
4/226 • Number of events 4 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
2.6%
6/227 • Number of events 6 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Infections and infestations
Streptococcal infection
|
1.3%
3/226 • Number of events 3 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
3.5%
8/227 • Number of events 8 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Infections and infestations
Sweating fever
|
0.88%
2/226 • Number of events 2 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.44%
1/227 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Nervous system disorders
Syncope
|
0.00%
0/226 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.44%
1/227 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
1.3%
3/226 • Number of events 3 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
2.2%
5/227 • Number of events 5 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Infections and infestations
Tinea infection
|
0.44%
1/226 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.00%
0/227 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Surgical and medical procedures
Tongue Tie operation
|
0.00%
0/226 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.44%
1/227 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar haemorrhage
|
0.44%
1/226 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.44%
1/227 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/226 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.88%
2/227 • Number of events 2 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Infections and infestations
Tonsillitis streptococcal
|
0.00%
0/226 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.88%
2/227 • Number of events 2 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Infections and infestations
Tooth Infection
|
0.00%
0/226 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.44%
1/227 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Gastrointestinal disorders
Toothache
|
0.44%
1/226 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.00%
0/227 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Musculoskeletal and connective tissue disorders
Torticollis
|
0.00%
0/226 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.44%
1/227 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Investigations
Tympanometry
|
0.00%
0/226 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.44%
1/227 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
1.3%
3/226 • Number of events 3 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
4.4%
10/227 • Number of events 10 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.7%
6/226 • Number of events 6 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
1.3%
3/227 • Number of events 3 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.44%
1/226 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.88%
2/227 • Number of events 2 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Infections and infestations
Urinary tract infection
|
0.44%
1/226 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
1.8%
4/227 • Number of events 4 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/226 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.44%
1/227 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Infections and infestations
Varicella
|
0.00%
0/226 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.44%
1/227 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
vasomotor rhinitis
|
0.44%
1/226 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.00%
0/227 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Infections and infestations
Viral Infection
|
0.44%
1/226 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.88%
2/227 • Number of events 2 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Infections and infestations
Viral Rash
|
0.44%
1/226 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.00%
0/227 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Infections and infestations
Viral Sinusitis
|
0.44%
1/226 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.00%
0/227 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Infections and infestations
Viral Upper Respiratory tract infection
|
0.44%
1/226 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.00%
0/227 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Gastrointestinal disorders
Vomitting
|
1.3%
3/226 • Number of events 3 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
1.8%
4/227 • Number of events 4 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.44%
1/226 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
1.3%
3/227 • Number of events 3 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/226 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.44%
1/227 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.44%
1/226 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.00%
0/227 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Infections and infestations
Acute Sinusitis
|
1.3%
3/226 • Number of events 3 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.88%
2/227 • Number of events 2 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Infections and infestations
Adenoviral upper respiratory infection
|
0.44%
1/226 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.00%
0/227 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic cough
|
0.44%
1/226 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.44%
1/227 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/226 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.44%
1/227 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Immune system disorders
Allergy to sting
|
0.00%
0/226 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.44%
1/227 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
|
Injury, poisoning and procedural complications
Animal Bite
|
0.00%
0/226 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
0.44%
1/227 • Number of events 1 • Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place