The purpose of this study is to assess safety profile of Prevenar 13™ when used among Korean adults in the routine clinical setting, as required for any new drug approved by Korea Food and Drug Administration (KFDA).
non-randomization, non-probability sampling
Study Type
OBSERVATIONAL
Enrollment
659
Non-intervention
Chungnam National University Hospital (CNUH)
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose (up to Day 29) that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious AE.
Time frame: Baseline (Day 1) up to Day 29
Duration of Adverse Events (AEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Duration of adverse event (in days) was defined as total time from onset of adverse event till the event was resolved during study.
Time frame: Baseline (Day 1) up to Day 29
Number of Participants With Treatment-Emergent Adverse Events (AEs) by Severity
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed on basis of severity as follows: a) mild: did not caused any significant problem to the participant; b) moderate: caused problem that did not interfere significantly with usual activities or the clinical status, other therapy needed due to AE; c) severe: caused problem that interfered significantly with usual activities or the clinical status.
Time frame: Baseline (Day 1) up to Day 29
Number of Participants With Outcome in Response to Adverse Events (AEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Outcome of an AE was assessed among participants based on their response to a question 'Is the adverse event still present?' as 'yes', 'unknown' or 'no (resolved)' during study.
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Jung-gu, Daejeon, South Korea
Bundang 21st Clinic
Seongnam-si, Gyeonggi-do, South Korea
Lee soo yang Internal Medical Clinic
Guro-gu, Seoul, South Korea
Hansarang Internal Medicine Hospital
Busan, South Korea, South Korea
Shin Clinic Internal Medicine
Seoul, South Korea, South Korea
Pusan National University Hospital
Busan, South Korea
Pusan National University Hospital
Busan, South Korea
Keimyung University Dongsan Hospital
Daegu, South Korea
Samsung Happy Clinic
Daejeon, South Korea
Chungnam National University Hospital
Daejeon, South Korea
...and 17 more locations
Time frame: Baseline (Day 1) up to Day 29
Number of Participants Who Discontinued Due to Adverse Events (AEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Time frame: Baseline (Day 1) up to Day 29
Percentage of Adverse Events (AEs) With Their Causal Relationship to Study Drug
Criteria: a)Certain: followed a reasonable time sequence from administration of drug; unexplained by other drugs, chemical substance or accompanying diseases;had clinically reasonable reaction on cessation of drug; had pharmacological or phenomenological reaction to re-administration of drug, b)Probable: followed a reasonable time sequence from administration of the drug; unexplained by other drugs;chemical substance or accompanying diseases; had clinically reasonable reaction on cessation of the drug, c)Possible:followed a reasonable time sequence from administration of drug; can also be explained by other drugs;chemical substance or accompanying diseases; lacks information or had unclear information on discontinuation of drug, d)Unlikely:not likely to had a reasonable causal relationship from administration of drug; seemed temporary; can also be reasonably explained by other drugs; chemical substances or latent diseases; conditional (need more data for true assessment),unaccessible.
Time frame: Baseline (Day 1) up to Day 29