Investigational Product - IV Dosing

1 forms

StudyEvent: ODM
1. Investigational Product - IV Dosing

Name

Type

Description | Question | Decode (Coded Value)

Data type

Alias

Administrative documentation

Item Group

Administrative Data

C1320722 (UMLS CUI-1)

Clinical Trial Subject Unique Identifier

Item

Subject Identifier

integer

C2348585 (UMLS CUI [1])

Experimental drug, Dosage

Item Group

Investigational Product - IV Dosing (Hycamtin)

C0304229 (UMLS CUI-1)
C0178602 (UMLS CUI-2)

Experimental drug, Dosage, chemotherapeutics regimen status cycle number

Item

Cycle Number

text

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C2045829 (UMLS CUI [1,3])

Experimental drug, Dosing, Cycle, Numbers

Code List

Cycle Number

CL Item

1 (1)

CL Item

1 (2)

CL Item

2 (3)

CL Item

2 (4)

CL Item

3 (5)

CL Item

3 (6)

CL Item

4 (7)

CL Item

4 (8)

CL Item

5 (9)

CL Item

5 (10)

CL Item

6 (11)

CL Item

6 (12)

Experimental drug, Dosage, Day

Item

Day

text

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0439228 (UMLS CUI [1,3])

Experimental drug, Dosing, Cycle, Numbers

Code List

Day

CL Item

1 (1)

CL Item

8 (2)

CL Item

1 (3)

CL Item

8 (4)

CL Item

1 (5)

CL Item

8 (6)

CL Item

1 (7)

CL Item

8 (8)

CL Item

1 (9)

CL Item

8 (10)

CL Item

1 (11)

CL Item

8 (12)

Experimental drug, Dosage, Start Date

Item

Infusion Start Date

date

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])

Experimental drug, Dosage, Start Time

Item

Infusion Start Time

time

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])

Experimental drug, Dosage, End Date

Item

Infusion Stop Date

date

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])

Experimental drug, Dosage, End Time

Item

Infusion Stop Time

time

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])

Experimental drug, Dosage

Item

Dose

integer

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])

Experimental drug, Dosage, Actual

Item

Actual Dose

integer

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0237400 (UMLS CUI [1,3])

Experimental drug, Dosage, Delay of drug therapy

Item

Was cycle 1, day 8 dose delayed?

boolean

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1299700 (UMLS CUI [1,3])

Experimental drug, Dosage, Delay of drug therapy, Reason and justification

Item

If Yes, check the Primary Reason

text

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1299700 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])

Experimental drug, Dosage, Delay of drug therapy, Reason and justification

Code List

If Yes, check the Primary Reason

CL Item

Hematologic Toxicity (1)

CL Item

Non-Hematologic Toxicity (2)

CL Item

Other, specify (3)

Experimental drug, Dosage, Delay of drug therapy, Reason and justification

Item

Specify

text

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1299700 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])

Experimental drug, Dosage, Delay of drug therapy, Reason and justification

Code List

Specify

Experimental drug, Dosage, Dose Reduced

Item

Was cycle 1, day 8 dose reduced?

boolean

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1707814 (UMLS CUI [1,3])

Experimental drug, Dosage, Dose Reduced, Reason and justification

Item

If Yes, check the Primary Reason

text

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1707814 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])

Experimental drug, Dosage, Dose Reduced, Reason and justification

Code List

If Yes, check the Primary Reason

CL Item

Hematologic Toxicity (1)

CL Item

Non-Hematologic Toxicity (2)

CL Item

Other, specify (3)

Experimental drug, Dosage, Dose Reduced, Reason and justification

Item

Specify

text

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1707814 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])

Experimental drug, Dosage, Delay of drug therapy

Item

Was cycle 2, day 1 dose delayed?

boolean

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1299700 (UMLS CUI [1,3])

Experimental drug, Dosage, Delay of drug therapy, Reason and justification

Item

If Yes, check the Primary Reason

text

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1299700 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])

Experimental drug, Dosage, Delay of drug therapy, Reason and justification

Code List

If Yes, check the Primary Reason

CL Item

Hematologic Toxicity (1)

CL Item

Non-Hematologic Toxicity (2)

CL Item

Other, specify (3)

Experimental drug, Dosage, Delay of drug therapy, Reason and justification

Item

Specify

text

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1299700 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])

Experimental drug, Dosage, Delay of drug therapy, Reason and justification

Code List

Specify

Experimental drug, Dosage, Dose Reduced

Item

Was cycle 2, day 1 dose reduced?

boolean

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1707814 (UMLS CUI [1,3])

Experimental drug, Dosage, Dose Reduced, Reason and justification

Item

Specify

text

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1707814 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])

Experimental drug, Dosage, Delay of drug therapy

Item

Was cycle 2, day 8 dose delayed?

boolean

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1299700 (UMLS CUI [1,3])

Experimental drug, Dosage, Delay of drug therapy, Reason and justification

Item

If Yes, check the Primary Reason

text

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1299700 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])

Experimental drug, Dosage, Delay of drug therapy, Reason and justification

Code List

If Yes, check the Primary Reason

CL Item

Hematologic Toxicity (1)

CL Item

Non-Hematologic Toxicity (2)

CL Item

Other, specify (3)

Experimental drug, Dosage, Delay of drug therapy, Reason and justification

Item

Specify

text

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1299700 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])

Experimental drug, Dosage, Delay of drug therapy, Reason and justification

Code List

Specify

Experimental drug, Dosage, Dose Reduced

Item

Was cycle 2, day 8 dose reduced?

boolean

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1707814 (UMLS CUI [1,3])

Experimental drug, Dosage, Dose Reduced, Reason and justification

Item

If Yes, check the Primary Reason

text

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1707814 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])

Experimental drug, Dosage, Dose Reduced, Reason and justification

Code List

If Yes, check the Primary Reason

CL Item

Hematologic Toxicity (1)

CL Item

Non-Hematologic Toxicity (2)

CL Item

Other, specify (3)

Experimental drug, Dosage, Dose Reduced, Reason and justification

Item

Specify

text

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1707814 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])

Experimental drug, Dosage, Delay of drug therapy

Item

Was cycle 3, day 1 dose delayed?

boolean

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1299700 (UMLS CUI [1,3])

Experimental drug, Dosage, Delay of drug therapy, Reason and justification

Item

If Yes, check the Primary Reason

text

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1299700 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])

Experimental drug, Dosage, Delay of drug therapy, Reason and justification

Code List

If Yes, check the Primary Reason

CL Item

Hematologic Toxicity (1)

CL Item

Non-Hematologic Toxicity (2)

CL Item

Other, specify (3)

Experimental drug, Dosage, Delay of drug therapy, Reason and justification

Item

Specify

text

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1299700 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])

Experimental drug, Dosage, Delay of drug therapy, Reason and justification

Code List

Specify

Experimental drug, Dosage, Dose Reduced

Item

Was cycle 3, day 1 dose reduced?

boolean

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1707814 (UMLS CUI [1,3])

Experimental drug, Dosage, Dose Reduced, Reason and justification

Item

If Yes, check the Primary Reason

text

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1707814 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])

Experimental drug, Dosage, Dose Reduced, Reason and justification

Code List

If Yes, check the Primary Reason

CL Item

Hematologic Toxicity (1)

CL Item

Non-Hematologic Toxicity (2)

CL Item

Other, specify (3)

Experimental drug, Dosage, Dose Reduced, Reason and justification

Item

Specify

text

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1707814 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])

Experimental drug, Dosage, Delay of drug therapy

Item

Was cycle 3, day 8 dose delayed?

boolean

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1299700 (UMLS CUI [1,3])

Experimental drug, Dosage, Delay of drug therapy, Reason and justification

Item

If Yes, check the Primary Reason

text

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1299700 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])

Experimental drug, Dosage, Delay of drug therapy, Reason and justification

Code List

If Yes, check the Primary Reason

CL Item

Hematologic Toxicity (1)

CL Item

Non-Hematologic Toxicity (2)

CL Item

Other, specify (3)

Experimental drug, Dosage, Delay of drug therapy, Reason and justification

Item

Specify

text

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1299700 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])

Experimental drug, Dosage, Delay of drug therapy, Reason and justification

Code List

Specify

Experimental drug, Dosage, Dose Reduced

Item

Was cycle 3, day 8 dose reduced?

boolean

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1707814 (UMLS CUI [1,3])

Experimental drug, Dosage, Dose Reduced, Reason and justification

Item

If Yes, check the Primary Reason

text

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1707814 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])

Experimental drug, Dosage, Dose Reduced, Reason and justification

Code List

If Yes, check the Primary Reason

CL Item

Hematologic Toxicity (1)

CL Item

Non-Hematologic Toxicity (2)

CL Item

Other, specify (3)

Experimental drug, Dosage, Dose Reduced, Reason and justification

Item

Specify

text

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1707814 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])

Experimental drug, Dosage, Delay of drug therapy

Item

Was cycle 4, day 1 dose delayed?

boolean

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1299700 (UMLS CUI [1,3])

Experimental drug, Dosage, Delay of drug therapy, Reason and justification

Item

If Yes, check the Primary Reason

text

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1299700 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])

Experimental drug, Dosage, Delay of drug therapy, Reason and justification

Code List

If Yes, check the Primary Reason

CL Item

Hematologic Toxicity (1)

CL Item

Non-Hematologic Toxicity (2)

CL Item

Other, specify (3)

Experimental drug, Dosage, Delay of drug therapy, Reason and justification

Item

Specify

text

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1299700 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])

Experimental drug, Dosage, Delay of drug therapy, Reason and justification

Code List

Specify

Experimental drug, Dosage, Dose Reduced

Item

Was cycle 4, day 1 dose reduced?

boolean

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1707814 (UMLS CUI [1,3])

Experimental drug, Dosage, Dose Reduced, Reason and justification

Item

If Yes, check the Primary Reason

text

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1707814 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])

Experimental drug, Dosage, Dose Reduced, Reason and justification

Code List

If Yes, check the Primary Reason

CL Item

Hematologic Toxicity (1)

CL Item

Non-Hematologic Toxicity (2)

CL Item

Other, specify (3)

Experimental drug, Dosage, Dose Reduced, Reason and justification

Item

Specify

text

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1707814 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])

Experimental drug, Dosage, Delay of drug therapy

Item

Was cycle 4, day 8 dose delayed?

boolean

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1299700 (UMLS CUI [1,3])

Experimental drug, Dosage, Delay of drug therapy, Reason and justification

Item

Specify

text

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1299700 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])

Experimental drug, Dosage, Delay of drug therapy, Reason and justification

Code List

Specify

Experimental drug, Dosage, Dose Reduced

Item

Was cycle 4, day 8 dose reduced?

boolean

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1707814 (UMLS CUI [1,3])

Experimental drug, Dosage, Dose Reduced, Reason and justification

Item

If Yes, check the Primary Reason

text

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1707814 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])

Experimental drug, Dosage, Dose Reduced, Reason and justification

Code List

If Yes, check the Primary Reason

CL Item

Hematologic Toxicity (1)

CL Item

Non-Hematologic Toxicity (2)

CL Item

Other, specify (3)

Experimental drug, Dosage, Dose Reduced, Reason and justification

Item

Specify

text

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1707814 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])

Experimental drug, Dosage, Delay of drug therapy

Item

Was cycle 5, day 1 dose delayed?

boolean

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1299700 (UMLS CUI [1,3])

Experimental drug, Dosage, Delay of drug therapy, Reason and justification

Item

If Yes, check the Primary Reason

text

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1299700 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])

Experimental drug, Dosage, Delay of drug therapy, Reason and justification

Code List

If Yes, check the Primary Reason

CL Item

Hematologic Toxicity (1)

CL Item

Non-Hematologic Toxicity (2)

CL Item

Other, specify (3)

Experimental drug, Dosage, Delay of drug therapy, Reason and justification

Item

Specify

text

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1299700 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])

Experimental drug, Dosage, Delay of drug therapy, Reason and justification

Code List

Specify

Experimental drug, Dosage, Dose Reduced

Item

Was cycle 5, day 1 dose reduced?

boolean

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1707814 (UMLS CUI [1,3])

Experimental drug, Dosage, Dose Reduced, Reason and justification

Item

If Yes, check the Primary Reason

text

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1707814 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])

Experimental drug, Dosage, Dose Reduced, Reason and justification

Code List

If Yes, check the Primary Reason

CL Item

Hematologic Toxicity (1)

CL Item

Non-Hematologic Toxicity (2)

CL Item

Other, specify (3)

Experimental drug, Dosage, Dose Reduced, Reason and justification

Item

Specify

text

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1707814 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])

Experimental drug, Dosage, Delay of drug therapy

Item

Was cycle 5, day 8 dose delayed?

boolean

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1299700 (UMLS CUI [1,3])

Experimental drug, Dosage, Delay of drug therapy, Reason and justification

Item

If Yes, check the Primary Reason

text

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1299700 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])

Experimental drug, Dosage, Delay of drug therapy, Reason and justification

Code List

If Yes, check the Primary Reason

CL Item

Hematologic Toxicity (1)

CL Item

Non-Hematologic Toxicity (2)

CL Item

Other, specify (3)

Experimental drug, Dosage, Delay of drug therapy, Reason and justification

Item

Specify

text

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1299700 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])

Experimental drug, Dosage, Delay of drug therapy, Reason and justification

Code List

Specify

Experimental drug, Dosage, Dose Reduced

Item

Was cycle 5, day 8 dose reduced?

boolean

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1707814 (UMLS CUI [1,3])

Experimental drug, Dosage, Dose Reduced, Reason and justification

Item

If Yes, check the Primary Reason

text

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1707814 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])

Experimental drug, Dosage, Dose Reduced, Reason and justification

Code List

If Yes, check the Primary Reason

CL Item

Hematologic Toxicity (1)

CL Item

Non-Hematologic Toxicity (2)

CL Item

Other, specify (3)

Experimental drug, Dosage, Dose Reduced, Reason and justification

Item

Specify

text

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1707814 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])

Experimental drug, Dosage, Delay of drug therapy

Item

Was cycle 6, day 1 dose delayed?

boolean

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1299700 (UMLS CUI [1,3])

Experimental drug, Dosage, Delay of drug therapy, Reason and justification

Item

If Yes, check the Primary Reason

text

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1299700 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])

Experimental drug, Dosage, Delay of drug therapy, Reason and justification

Code List

If Yes, check the Primary Reason

CL Item

Hematologic Toxicity (1)

CL Item

Non-Hematologic Toxicity (2)

CL Item

Other, specify (3)

Experimental drug, Dosage, Delay of drug therapy, Reason and justification

Item

Specify

text

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1299700 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])

Experimental drug, Dosage, Delay of drug therapy, Reason and justification

Code List

Specify

Experimental drug, Dosage, Dose Reduced

Item

Was cycle 6, day 1 dose reduced?

boolean

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1707814 (UMLS CUI [1,3])

Experimental drug, Dosage, Dose Reduced, Reason and justification

Item

If Yes, check the Primary Reason

text

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1707814 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])

Experimental drug, Dosage, Dose Reduced, Reason and justification

Code List

If Yes, check the Primary Reason

CL Item

Hematologic Toxicity (1)

CL Item

Non-Hematologic Toxicity (2)

CL Item

Other, specify (3)

Experimental drug, Dosage, Dose Reduced, Reason and justification

Item

Specify

text

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1707814 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])

Experimental drug, Dosage, Delay of drug therapy

Item

Was cycle 6, day 8 dose delayed?

boolean

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1299700 (UMLS CUI [1,3])

Experimental drug, Dosage, Delay of drug therapy, Reason and justification

Item

If Yes, check the Primary Reason

text

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1299700 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])

Experimental drug, Dosage, Delay of drug therapy, Reason and justification

Code List

If Yes, check the Primary Reason

CL Item

Hematologic Toxicity (1)

CL Item

Non-Hematologic Toxicity (2)

CL Item

Other, specify (3)

Experimental drug, Dosage, Delay of drug therapy, Reason and justification

Item

Specify

text

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1299700 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])

Experimental drug, Dosage, Delay of drug therapy, Reason and justification

Code List

Specify

Experimental drug, Dosage, Dose Reduced

Item

Was cycle 6, day 8 dose reduced?

boolean

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1707814 (UMLS CUI [1,3])

Experimental drug, Dosage, Dose Reduced, Reason and justification

Item

If Yes, check the Primary Reason

text

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1707814 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])

Experimental drug, Dosage, Dose Reduced, Reason and justification

Code List

If Yes, check the Primary Reason

CL Item

Hematologic Toxicity (1)

CL Item

Non-Hematologic Toxicity (2)

CL Item

Other, specify (3)

Experimental drug, Dosage, Dose Reduced, Reason and justification

Item

Specify

text

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1707814 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])

Experimental drug, Dosage

Item Group

Investigational Product - IV Dosing (Carboplatin)

C0304229 (UMLS CUI-1)
C0178602 (UMLS CUI-2)

Experimental drug, Dosage, chemotherapeutics regimen status cycle number

Item

Cycle Number

text

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C2045829 (UMLS CUI [1,3])

Experimental drug, Dosing, Cycle, Numbers

Code List

Cycle Number

CL Item

1 (1)

CL Item

2 (2)

CL Item

3 (3)

CL Item

4 (4)

CL Item

5 (5)

CL Item

6 (6)

Experimental drug, Dosage, Day

Item

Day

text

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0439228 (UMLS CUI [1,3])

Experimental drug, Dosing, Cycle, Numbers

Code List

Day

CL Item

1 (1)

CL Item

1 (2)

CL Item

1 (3)

CL Item

1 (4)

CL Item

1 (5)

CL Item

1 (6)

Experimental drug, Dosage, Start Date

Item

Infusion Start Date

date

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])

Experimental drug, Dosage, Start Time

Item

Infusion Start Time

time

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])

Experimental drug, Dosage, End Date

Item

Infusion Stop Date

date

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])

Experimental drug, Dosage, End Time

Item

Infusion Stop Time

time

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])

Experimental drug, Dosage

Item

Dose

integer

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])

Experimental drug, Dosage, Actual

Item

Actual Dose

integer

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0237400 (UMLS CUI [1,3])

Experimental drug, Dosage, Delay of drug therapy

Item

Was cycle 2 dose delayed?

boolean

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1299700 (UMLS CUI [1,3])

Experimental drug, Dosage, Delay of drug therapy, Reason and justification

Item

If Yes, check the Primary Reason

text

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1299700 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])

Experimental drug, Dosage, Delay of drug therapy, Reason and justification

Code List

If Yes, check the Primary Reason

CL Item

Hematologic Toxicity (1)

CL Item

Non-Hematologic Toxicity (2)

CL Item

Other, specify (3)

Experimental drug, Dosage, Delay of drug therapy, Reason and justification

Item

Specify

text

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1299700 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])

Experimental drug, Dosage, Delay of drug therapy, Reason and justification

Code List

Specify

Experimental drug, Dosage, Dose Reduced

Item

Was cycle 2 dose reduced?

boolean

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1707814 (UMLS CUI [1,3])

Experimental drug, Dosage, Dose Reduced, Reason and justification

Item

If Yes, check the Primary Reason

text

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1707814 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])

Experimental drug, Dosage, Dose Reduced, Reason and justification

Code List

If Yes, check the Primary Reason

CL Item

Hematologic Toxicity (1)

CL Item

Non-Hematologic Toxicity (2)

CL Item

Other, specify (3)

Experimental drug, Dosage, Dose Reduced, Reason and justification

Item

Specify

text

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1707814 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])

Experimental drug, Dosage, Delay of drug therapy

Item

Was cycle 3 dose delayed?

boolean

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1299700 (UMLS CUI [1,3])

Experimental drug, Dosage, Delay of drug therapy, Reason and justification

Item

If Yes, check the Primary Reason

text

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1299700 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])

Experimental drug, Dosage, Delay of drug therapy, Reason and justification

Code List

If Yes, check the Primary Reason

CL Item

Hematologic Toxicity (1)

CL Item

Non-Hematologic Toxicity (2)

CL Item

Other, specify (3)

Experimental drug, Dosage, Delay of drug therapy, Reason and justification

Item

Specify

text

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1299700 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])

Experimental drug, Dosage, Delay of drug therapy, Reason and justification

Code List

Specify

Experimental drug, Dosage, Dose Reduced

Item

Was cycle 3 dose reduced?

boolean

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1707814 (UMLS CUI [1,3])

Experimental drug, Dosage, Dose Reduced, Reason and justification

Item

If Yes, check the Primary Reason

text

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1707814 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])

Experimental drug, Dosage, Dose Reduced, Reason and justification

Code List

If Yes, check the Primary Reason

CL Item

Hematologic Toxicity (1)

CL Item

Non-Hematologic Toxicity (2)

CL Item

Other, specify (3)

Experimental drug, Dosage, Dose Reduced, Reason and justification

Item

Specify

text

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1707814 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])

Experimental drug, Dosage, Delay of drug therapy

Item

Was cycle 4 dose delayed?

boolean

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1299700 (UMLS CUI [1,3])

Experimental drug, Dosage, Delay of drug therapy, Reason and justification

Item

If Yes, check the Primary Reason

text

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1299700 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])

Experimental drug, Dosage, Delay of drug therapy, Reason and justification

Code List

If Yes, check the Primary Reason

CL Item

Hematologic Toxicity (1)

CL Item

Non-Hematologic Toxicity (2)

CL Item

Other, specify (3)

Experimental drug, Dosage, Delay of drug therapy, Reason and justification

Item

Specify

text

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1299700 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])

Experimental drug, Dosage, Delay of drug therapy, Reason and justification

Code List

Specify

Experimental drug, Dosage, Dose Reduced

Item

Was cycle 4 dose reduced?

boolean

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1707814 (UMLS CUI [1,3])

Experimental drug, Dosage, Dose Reduced, Reason and justification

Item

If Yes, check the Primary Reason

text

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1707814 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])

Experimental drug, Dosage, Dose Reduced, Reason and justification

Code List

If Yes, check the Primary Reason

CL Item

Hematologic Toxicity (1)

CL Item

Non-Hematologic Toxicity (2)

CL Item

Other, specify (3)

Experimental drug, Dosage, Dose Reduced, Reason and justification

Item

Specify

text

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1707814 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])

Experimental drug, Dosage, Delay of drug therapy

Item

Was cycle 5 dose delayed?

boolean

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1299700 (UMLS CUI [1,3])

Experimental drug, Dosage, Delay of drug therapy, Reason and justification

Item

If Yes, check the Primary Reason

text

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1299700 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])

Experimental drug, Dosage, Delay of drug therapy, Reason and justification

Code List

If Yes, check the Primary Reason

CL Item

Hematologic Toxicity (1)

CL Item

Non-Hematologic Toxicity (2)

CL Item

Other, specify (3)

Experimental drug, Dosage, Delay of drug therapy, Reason and justification

Item

Specify

text

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1299700 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])

Experimental drug, Dosage, Delay of drug therapy, Reason and justification

Code List

Specify

Experimental drug, Dosage, Dose Reduced

Item

Was cycle 5 dose reduced?

boolean

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1707814 (UMLS CUI [1,3])

Experimental drug, Dosage, Dose Reduced, Reason and justification

Item

If Yes, check the Primary Reason

text

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1707814 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])

Experimental drug, Dosage, Dose Reduced, Reason and justification

Code List

If Yes, check the Primary Reason

CL Item

Hematologic Toxicity (1)

CL Item

Non-Hematologic Toxicity (2)

CL Item

Other, specify (3)

Experimental drug, Dosage, Dose Reduced, Reason and justification

Item

Specify

text

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1707814 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])

Experimental drug, Dosage, Delay of drug therapy

Item

Was cycle 5 dose delayed?

boolean

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1299700 (UMLS CUI [1,3])

Experimental drug, Dosage, Delay of drug therapy, Reason and justification

Item

If Yes, check the Primary Reason

text

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1299700 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])

Experimental drug, Dosage, Delay of drug therapy, Reason and justification

Code List

If Yes, check the Primary Reason

CL Item

Hematologic Toxicity (1)

CL Item

Non-Hematologic Toxicity (2)

CL Item

Other, specify (3)

Experimental drug, Dosage, Delay of drug therapy, Reason and justification

Item

Specify

text

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1299700 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])

Experimental drug, Dosage, Delay of drug therapy, Reason and justification

Code List

Specify

Experimental drug, Dosage, Dose Reduced

Item

Was cycle 5 dose reduced?

boolean

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1707814 (UMLS CUI [1,3])

Experimental drug, Dosage, Dose Reduced, Reason and justification

Item

If Yes, check the Primary Reason

text

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1707814 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])

Experimental drug, Dosage, Dose Reduced, Reason and justification

Code List

If Yes, check the Primary Reason

CL Item

Hematologic Toxicity (1)

CL Item

Non-Hematologic Toxicity (2)

CL Item

Other, specify (3)

Experimental drug, Dosage, Dose Reduced, Reason and justification

Item

Specify

text

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1707814 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])

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Investigational Product - IV Dosing

Description

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