Abnormal findings at the Screening Visit

1 Formulär

StudyEvent: ODM
1. Abnormal findings at the Screening Visit

Administration

Beskrivning

Administration

Alias

UMLS CUI-1: C1320722

Patient number

Beskrivning

Patient number

Datatyp

integer

Alias

UMLS CUI [1]: C1830427

Visit date

Beskrivning

Visit date

Datatyp

date

Alias

UMLS CUI [1]: C1320303

Center Number

Beskrivning

Center Number

Datatyp

integer

Alias

UMLS CUI [1,1]: C1301943

UMLS CUI [1,2]: C0600091

Electrocardiogram (12 lead)

Beskrivning

Electrocardiogram (12 lead)

Alias

UMLS CUI-1: C0430456

Date of ECG

Beskrivning

Dato of ECG

Datatyp

date

Alias

UMLS CUI [1]: C2826640

Were any clinically significant abnormalities detected?

Beskrivning

If ’Yes’, please record details in the Baseline Signs and Symptoms and/or SAE section at the back of this book and exclude the patient from the study.

Datatyp

integer

Alias

UMLS CUI [1]: C0522055

No (1)

Yes (2)

Laboratory evaluation

Beskrivning

Laboratory evaluation

Alias

UMLS CUI-1: C0022885

Date of sample

Beskrivning

Date of sample

Datatyp

date

Alias

UMLS CUI [1]: C1302413

Were any clinically significant abnormalities detected?

Beskrivning

If ‘Yes’, please record the findings and/or diagnosis in the Baseline Signs and Symptoms and/or SAE section at the back of this book and exclude the patient from the study.