Informed consent | parent | Study Subject Participation Status | Compliance behavior
Item
1. parent / guardian must be able to give written informed consent prior to participation in the study, which includes ability to comply with the requirements and restrictions listed in the consent form. informed consent must be obtained prior to undertaking any study procedures.
boolean
C0021430 (UMLS CUI [1,1])
C0030551 (UMLS CUI [1,2])
C0085732 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C1321605 (UMLS CUI [2,3])
Assent | Child
Item
2. assent should be obtained from all children in the study where appropriate.
boolean
C1879749 (UMLS CUI [1,1])
C0008059 (UMLS CUI [1,2])
Age | Gender
Item
3. male or female subject aged between 1 - 17 years inclusive at screening.
boolean
C0001779 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Parent | Able to read | Comprehension | Able to write | Compliance behavior
Item
4. the parent / guardian, or where appropriate the child must be able to read, comprehend, and write at a sufficient level to complete study related materials.
boolean
C0030551 (UMLS CUI [1,1])
C0586740 (UMLS CUI [1,2])
C0162340 (UMLS CUI [1,3])
C0584993 (UMLS CUI [1,4])
C1321605 (UMLS CUI [1,5])
Study Subject Participation Status
Item
5. subjects will be allowed to enrol in other studies while taking part on this study. however, permission from the scientific board must be obtained to enrol or allow the continued participation of a subject enrolled in another study.
boolean
C2348568 (UMLS CUI [1])
Child | Medically unfit | Physical Examination
Item
1. as a result of medical interview, physical examination or screening investigation the physician responsible considers the child unfit for the study.
boolean
C0008059 (UMLS CUI [1,1])
C3841806 (UMLS CUI [1,2])
C0031809 (UMLS CUI [2])
Drug Allergy | Other allergy | Medical contraindication | Study Subject Participation Status
Item
2. the subject has a history of drug or other allergy, which, in the opinion of the responsable physician, contra-indicates their participation.
boolean
C0013182 (UMLS CUI [1])
C2886714 (UMLS CUI [2])
C1301624 (UMLS CUI [3,1])
C2348568 (UMLS CUI [3,2])
Pregnancy | Breast Feeding | Postpartum Period | Breastfeeding stopped
Item
3. subject is female who is pregnant or lactating or up to 6 weeks post partum or 6 weeks cessation of breast feeding. if a woman is subsequently found to have been pregnant at the time of an assessment data from that assessment will not be included in the analyses
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0086839 (UMLS CUI [3])
C0420983 (UMLS CUI [4])
Study Subject Participation Status | Investigational New Drugs | Medical Procedure (invasive)
Item
4. the child has participated within 3 months of the first dose in a study using a new molecular entity, or the first dose in any other study investigating drugs or having participated within three months in a study with invasive procedures. any u-biopred assessments should be deferred until 3 months after the first dose or invasive procedure. permission from the scientific board must be obtained to enroll or allow the continued participation of a child enrolled in another study.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C1548804 (UMLS CUI [3])
Compliance behavior | Risk Assessment
Item
5. those who, in the opinion of the investigator, have a risk of non-compliance with study procedures.
boolean
C1321605 (UMLS CUI [1,1])
C0086930 (UMLS CUI [1,2])
Gestational Age
Item
6. prematurity ≤35 weeks gestation
boolean
C0017504 (UMLS CUI [1])
Asthma | Change of medication | Child | Symbicort | Therapeutic procedure
Item
7. the child had changed asthma medication within 4 weeks of the screening assessment(except those using the symbicort maintenance and reliever therapy (smart) regime)(assessment should be deferred)
boolean
C0004096 (UMLS CUI [1,1])
C0580105 (UMLS CUI [1,2])
C0008059 (UMLS CUI [1,3])
C1121854 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
Upper Respiratory Infections | Lower respiratory tract infection | Common Cold
Item
8. history or current evidence of an upper or lower respiratory infection or symptoms (including common cold) within 2 weeks of baseline assessment (assessment should be deferred).
boolean
C0041912 (UMLS CUI [1])
C0149725 (UMLS CUI [2])
C0009443 (UMLS CUI [3])
Exacerbation of asthma | Severe | Child | Emergency room admission | Hospital admission | Adrenal Cortex Hormones
Item
9. the child has had a severe exacerbation (requiring er attendance or hospital admission and/or a course of high dose ocs for at least 3 days duration) within 4 weeks of the baseline assessment (assessment should be deferred).
boolean
C0349790 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0008059 (UMLS CUI [1,3])
C0583237 (UMLS CUI [2])
C0184666 (UMLS CUI [3])
C0001617 (UMLS CUI [4])