Safety of once-daily administration of Fluticasone nasal spray in adults and adolescents with perennial allergic rhinitis GSK 102123

Beskrivning

If Yes, answer the following items for each medication using Trade Names where possible.

Datatyp

text

Alias

UMLS CUI [1,1]

C2347852

UMLS CUI [1,2]

C0035455

Beskrivning

Trade name preferred

Datatyp

text

Alias

UMLS CUI [1,1]

C2360065

UMLS CUI [1,2]

C2347852

UMLS CUI [1,3]

C2607914

Beskrivning

Unit dose

Datatyp

float

Alias

UMLS CUI [1,1]

C2826767

UMLS CUI [1,2]

C2607914

Beskrivning

The following list of abbreviations are examples which can be used to aid the completion of this item. This is not an all inclusive list and is for guidance only, other abbreviations not listed may be used if necessary. ACTU = Actuation AMP = Amoule APP = Application BOT = Bottle CC = Cubic centimeter CAP = Capsule G = Gram GTT = Drops IU = International Units L = Litre L/MIN = Litres per minute LOZ = Lozenge MCG = Microgram MCG/KG/MIN = Microgram per kilogram per minute MCL = Microlitre MMOL = Millimole NEB = Nebule PUFF = Puff SPR = Spray TAB = Tablet TBLSP = Tablespoon TSP = Teaspoon % = Percent UNK = Unkown

Datatyp

text

Alias

UMLS CUI [1,1]

C2826646

UMLS CUI [1,2]

C2607914

Beskrivning

The following list of abbreviations are examples which can be used to aid the completion of this item. The list is not all inclusive and is for guidance only, other abbreviations not listed may be used if necessary. OD/QD = 1 X daily BID = 2 X daily TID = 3 X daily QID = 4 X daily CONT = Continuous CUM = Cumulative dose D = Daily INT = Intermittent NA = Not available NOCT = At night OTH = Other PRN = As required QH = Every hour (quaque hora) QOD = Every other day QN = Every night (quaque nocte) SD = Single dose STAT = Immediately TAP = Taper UNK = Unknown

Datatyp

text

Alias

UMLS CUI [1,1]

C2826654

UMLS CUI [1,2]

C2607914

Beskrivning

The following list of abbreviations are examples which can be used to aid the completion of this item. It is not all inclusive and is for guidance only, other abbreviations not listed may be used if necessary. IM = Intramuscular IH = Inhalation IN = Intranasal INJ = Injection IV = Intravenous NS = Nasal OTH = Other PO = Oral PR = Rectal SC = Subcutaneous TP = Topical UNK = Unknown

Datatyp

text

Alias

UMLS CUI [1,1]

C2826730

UMLS CUI [1,2]

C2607914

Beskrivning

Check that either medication start date is completed or ’Taken Prior to Study?’ is ’Yes’. It is acceptable for start date to be missing if ’Taken Prior to Study?’ is ’Yes’. It is acceptable if ’Taken Prior to Study?’ is ’Yes’ and a start date is present, as long as the start date is prior to the date of the subject’s initial visit.

Datatyp

date

Alias

UMLS CUI [1,1]

C2826734

UMLS CUI [1,2]

C2607914

Beskrivning

Check that either medication start date is completed or ’Taken Prior to Study?’ is ’Yes’. It is acceptable for start date to be missing if ’Taken Prior to Study?’ is ’Yes’. It is acceptable if ’Taken Prior to Study?’ is ’Yes’ and a start date is present, as long as the start date is prior to the date of the subject’s initial visit.

Datatyp

text

Alias

UMLS CUI [1,1]

C2826667

UMLS CUI [1,2]

C2607914

Beskrivning

Check that either medication stop date is completed or ’Ongoing Medication?’ is ’Yes’. It is acceptable for stop date to be missing if ’Ongoing Medication?’ is ’Yes’.

Datatyp

date

Alias

UMLS CUI [1,1]

C2826744

UMLS CUI [1,2]

C2607914

Beskrivning

Check that either medication stop date is completed or ’Ongoing Medication?’ is ’Yes’. It is acceptable for stop date to be missing if ’Ongoing Medication?’ is ’Yes’.

Datatyp

text

Alias

UMLS CUI [1,1]

C2826666

UMLS CUI [1,2]

C2607914

Beskrivning

If Yes, record each medication in the following items of this itemgroup, use Trade Names where possible.

Datatyp

text

Alias

UMLS CUI [1,1]

C2347852

UMLS CUI [1,2]

C0205394

Beskrivning

Trade names are preferred

Datatyp

text

Alias

UMLS CUI [1,1]

C2347852

UMLS CUI [1,2]

C2360065

Beskrivning

Unit Dose

Datatyp

float

Alias

UMLS CUI [1]

C2826767

Beskrivning

The following list of abbreviations are examples which can be used to aid the completion of this item. This is not an all inclusive list and is for guidance only, other abbreviations not listed may be used if necessary. ACTU = Actuation AMP = Amoule APP = Application BOT = Bottle CC = Cubic centimeter CAP = Capsule G = Gram GTT = Drops IU = International Units L = Litre L/MIN = Litres per minute LOZ = Lozenge MCG = Microgram MCG/KG/MIN = Microgram per kilogram per minute MCL = Microlitre MMOL = Millimole NEB = Nebule PUFF = Puff SPR = Spray TAB = Tablet TBLSP = Tablespoon TSP = Teaspoon % = Percent UNK = Unkown

Datatyp

text

Alias

UMLS CUI [1]

C2826646

Beskrivning

The following list of abbreviations are examples which can be used to aid the completion of this item. The list is not all inclusive and is for guidance only, other abbreviations not listed may be used if necessary. OD/QD = 1 X daily BID = 2 X daily TID = 3 X daily QID = 4 X daily CONT = Continuous CUM = Cumulative dose D = Daily INT = Intermittent NA = Not available NOCT = At night OTH = Other PRN = As required QH = Every hour (quaque hora) QOD = Every other day QN = Every night (quaque nocte) SD = Single dose STAT = Immediately TAP = Taper UNK = Unknown

Datatyp

text

Alias

UMLS CUI [1]

C2826654

Beskrivning

The following list of abbreviations are examples which can be used to aid the completion of this item. It is not all inclusive and is for guidance only, other abbreviations not listed may be used if necessary. IM = Intramuscular IH = Inhalation IN = Intranasal INJ = Injection IV = Intravenous NS = Nasal OTH = Other PO = Oral PR = Rectal SC = Subcutaneous TP = Topical UNK = Unknown

Datatyp

text

Alias

UMLS CUI [1]

C2826730

Beskrivning

Ensure that the ’Reason for Medication’ is recorded on one of the following pages using the same terms: Current Medical Conditions (Medical and Allergy History), Non-Serious Adverse Events or Serious Adverse Events Form.

Datatyp

text

Alias

UMLS CUI [1]

C2826696

Beskrivning

Check that either medication start date is completed or ’Taken Prior to Study?’ is ’Yes’. It is acceptable for start date to be missing if ’Taken Prior to Study?’ is ’Yes’. It is acceptable if ’Taken Prior to Study?’ is ’Yes’ and a start date is present, as long as the start date is prior to the date of the subject’s initial visit.

Datatyp

date

Alias

UMLS CUI [1]

C2826734

Beskrivning

Check that either medication start date is completed or ’Taken Prior to Study?’ is ’Yes’. It is acceptable for start date to be missing if ’Taken Prior to Study?’ is ’Yes’. It is acceptable if ’Taken Prior to Study?’ is ’Yes’ and a start date is present, as long as the start date is prior to the date of the subject’s initial visit.

Datatyp

text

Alias

UMLS CUI [1]

C2826667

Beskrivning

Check that either medication stop date is completed or ’Ongoing Medication?’ is ’Yes’. It is acceptable for stop date to be missing if ’Ongoing Medication?’ is ’Yes’.

Datatyp

date

Alias

UMLS CUI [1]

C2826744

Beskrivning

Check that either medication stop date is completed or ’Ongoing Medication?’ is ’Yes’. It is acceptable for stop date to be missing if ’Ongoing Medication?’ is ’Yes’.

Datatyp

text

Alias

UMLS CUI [1]

C2826666