Beschreibung

Session number

Datentyp

integer

Alias

UMLS CUI [1,1]

C1883017

UMLS CUI [1,2]

C0750480

Beschreibung

Subject number

Datentyp

text

Alias

UMLS CUI [1]

C2348585

Beschreibung

Check that either the YES or NO box at the top of the page is selected. • If NO is selected, check that no applicable concomitant medications are present. • If YES is selected, check that at least one applicable concomitant medication is present. If YES, record below.

Datentyp

text

Alias

UMLS CUI [1]

C2347852

Beschreibung

Check that the drug name (trade name preferred) is spelled correctly. If medication is given to treat a serious adverse event (SAE), then the event must be recorded on the SERIOUS ADVERSE EVENT page(s).

Datentyp

text

Alias

UMLS CUI [1]

C0013227

Beschreibung

Dose

Datentyp

float

Alias

UMLS CUI [1]

C3174092

Beschreibung

Units

Datentyp

text

Alias

UMLS CUI [1]

C1519795

Beschreibung

Frequency

Datentyp

text

Alias

UMLS CUI [1]

C3476109

Beschreibung

Route

Datentyp

text

Alias

UMLS CUI [1]

C0013153

Beschreibung

Check that either the ‘Date started’ is completed or ‘started Pre-Follow Up Study’ is completed. At least one must be completed, but it is acceptable if both are completed. • If both ‘Date started’ and ‘started Pre-Follow Up Study’ are completed, check that the start date is pre-study.

Datentyp

date

Alias

UMLS CUI [1]

C3173309

Beschreibung

Check that either the ‘Date started’ is completed or ‘started Pre-Follow Up Study’ is completed. At least one must be completed, but it is acceptable if both are completed. • If both ‘Date started’ and ‘started Pre-Follow Up Study’ are completed, check that the start date is pre-study.

Datentyp

boolean

Alias

UMLS CUI [1]

C0016441

Beschreibung

Check that either the ‘Date stopped’ box is completed or the ‘continued Post-Follow Up Study’ is completed. Only one must be completed. • Check that the drug start date is before or equal to the drug stop date.

Datentyp

date

Alias

UMLS CUI [1]

C1531784

Beschreibung

Check that either the ‘Date stopped’ box is completed or the ‘continued Post-Follow Up Study’ is completed. Only one must be completed.

Datentyp

boolean

Alias

UMLS CUI [1]

C0016441

Beschreibung

Indication

Datentyp

text

Alias

UMLS CUI [1]

C3146298

Beschreibung

Prophylaxis

Datentyp

text

Alias

UMLS CUI [1]

C0199176

Beschreibung

If the concomitant medication was taken for a serious adverse event (SAE), check that the event is entered on the SERIOUS ADVERSE EVENT page(s) and that the dates are consistent with the event.

Datentyp

text

Alias

UMLS CUI [1,1]

C3469597

UMLS CUI [1,2]

C1519255