Study Coordinating Center, Identification number
Item
Center number
integer
C2825181 (UMLS CUI [1,1])
C1300638 (UMLS CUI [1,2])
Patient number
Item
Patient Number
integer
C1830427 (UMLS CUI [1])
Person Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Date of visit
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Serious Adverse Event
Item
Has the patient had any serious adverse experiences during this course?
boolean
C1519255 (UMLS CUI [1])
12 lead ECG, Requirement
Item
Required only if clinically indicated. Mark the box if not required.
boolean
C0430456 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
12 lead ECG, Date in time
Item
Date Performed
date
C0430456 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Result
text
C0430456 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
CL Item
No significant worsening since screening (1)
CL Item
Worsening since screening (2)
Experimental drug, Topotecan, Capsules, Amount Dispensed
Item
Number of Capsules Dispensed - 1.0 mg
integer
C0304229 (UMLS CUI [1,1])
C0146224 (UMLS CUI [1,2])
C0006935 (UMLS CUI [1,3])
C0805077 (UMLS CUI [1,4])
Experimental drug, Topotecan, Capsules, Amount Dispensed
Item
Number of Capsules Dispensed - 0.25 mg
integer
C0304229 (UMLS CUI [1,1])
C0146224 (UMLS CUI [1,2])
C0006935 (UMLS CUI [1,3])
C0805077 (UMLS CUI [1,4])
Experimental drug, Topotecan, Capsules, Taken
Item
Number of Capsules Taken - 1.0 mg
integer
C0304229 (UMLS CUI [1,1])
C0146224 (UMLS CUI [1,2])
C0006935 (UMLS CUI [1,3])
C1883727 (UMLS CUI [1,4])
Experimental drug, Topotecan, Capsules, Taken
Item
Number of Capsules Taken - 0.25 mg
integer
C0304229 (UMLS CUI [1,1])
C0146224 (UMLS CUI [1,2])
C0006935 (UMLS CUI [1,3])
C1883727 (UMLS CUI [1,4])
Experimental drug, Topotecan, Capsules, Amount Returned
Item
Number of Capsules Returned - 1.0 mg
integer
C0304229 (UMLS CUI [1,1])
C0146224 (UMLS CUI [1,2])
C0006935 (UMLS CUI [1,3])
C2699071 (UMLS CUI [1,4])
Experimental drug, Topotecan, Capsules, Amount Returned
Item
Number of Capsules Returned - 0.25 mg
integer
C0304229 (UMLS CUI [1,1])
C0146224 (UMLS CUI [1,2])
C0006935 (UMLS CUI [1,3])
C2699071 (UMLS CUI [1,4])