ID

37562

Description

Study ID: 104864/902 Clinical Study ID: 104864/902 Study Title: An Open-Label, Single-Arm, Phase II Study of IV Weekly (Days 1 and 8 Every 21 Days) HYCAMTIN in Combination With Carboplatin (Day 1 Every 21 Days) as Second-Line Therapy in Subjects With Potentially Platinum-Sensitive Relapsed Ovarian Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00316173 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: topotecan Trade Name: CARBOPLATIN Study Indication: Ovarian Cancer; Neoplasms, Ovarian

Keywords

Versions (1)
  1. 8/7/19 8/7/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 7, 2019

DOI

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License

Creative Commons BY-NC 3.0
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HYCAMTIN in Combination With Carboplatin in Subjects with Ovarian Cancer; NCT00316173

English

Investigational Product - IV Dosing

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Clinical Trial Subject Unique Identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585
Investigational Product - IV Dosing (Hycamtin)
Description

Investigational Product - IV Dosing (Hycamtin)

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0178602
Cycle Number
Description

Experimental drug, Dosage, chemotherapeutics regimen status cycle number

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C2045829
Day
Description

Experimental drug, Dosage, Day

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0439228
Infusion Start Date
Description

Experimental drug, Dosage, Start Date

Data type

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0808070
Infusion Start Time
Description

Experimental drug, Dosage, Start Time

Data type

time

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1301880
Infusion Stop Date
Description

Experimental drug, Dosage, End Date

Data type

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0806020
Infusion Stop Time
Description

Experimental drug, Dosage, End Time

Data type

time

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1522314
Dose
Description

Experimental drug, Dosage

Data type

integer

Measurement units
  • mg/m2
Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
mg/m2
Actual Dose
Description

Experimental drug, Dosage, Actual

Data type

integer

Measurement units
  • mg
Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0237400
mg
Was cycle 1, day 8 dose delayed?
Description

Experimental drug, Dosage, Delay of drug therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1299700
If Yes, check the Primary Reason
Description

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

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1299700
UMLS CUI [1,4]
C0566251
Specify
Description

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

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1299700
UMLS CUI [1,4]
C0566251
Was cycle 1, day 8 dose reduced?
Description

Experimental drug, Dosage, Dose Reduced

Data type

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1707814
If Yes, check the Primary Reason
Description

Experimental drug, Dosage, Dose Reduced, Reason and justification

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1707814
UMLS CUI [1,4]
C0566251
Specify
Description

Experimental drug, Dosage, Dose Reduced, Reason and justification

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1707814
UMLS CUI [1,4]
C0566251
Was cycle 2, day 1 dose delayed?
Description

Experimental drug, Dosage, Delay of drug therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1299700
If Yes, check the Primary Reason
Description

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

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1299700
UMLS CUI [1,4]
C0566251
Specify
Description

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

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1299700
UMLS CUI [1,4]
C0566251
Was cycle 2, day 1 dose reduced?
Description

Experimental drug, Dosage, Dose Reduced

Data type

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1707814
Specify
Description

Experimental drug, Dosage, Dose Reduced, Reason and justification

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1707814
UMLS CUI [1,4]
C0566251
Was cycle 2, day 8 dose delayed?
Description

Experimental drug, Dosage, Delay of drug therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1299700
If Yes, check the Primary Reason
Description

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

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1299700
UMLS CUI [1,4]
C0566251
Specify
Description

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

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1299700
UMLS CUI [1,4]
C0566251
Was cycle 2, day 8 dose reduced?
Description

Experimental drug, Dosage, Dose Reduced

Data type

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1707814
If Yes, check the Primary Reason
Description

Experimental drug, Dosage, Dose Reduced, Reason and justification

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1707814
UMLS CUI [1,4]
C0566251
Specify
Description

Experimental drug, Dosage, Dose Reduced, Reason and justification

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1707814
UMLS CUI [1,4]
C0566251
Was cycle 3, day 1 dose delayed?
Description

Experimental drug, Dosage, Delay of drug therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1299700
If Yes, check the Primary Reason
Description

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

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1299700
UMLS CUI [1,4]
C0566251
Specify
Description

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

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1299700
UMLS CUI [1,4]
C0566251
Was cycle 3, day 1 dose reduced?
Description

Experimental drug, Dosage, Dose Reduced

Data type

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1707814
If Yes, check the Primary Reason
Description

Experimental drug, Dosage, Dose Reduced, Reason and justification

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1707814
UMLS CUI [1,4]
C0566251
Specify
Description

Experimental drug, Dosage, Dose Reduced, Reason and justification

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1707814
UMLS CUI [1,4]
C0566251
Was cycle 3, day 8 dose delayed?
Description

Experimental drug, Dosage, Delay of drug therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1299700
If Yes, check the Primary Reason
Description

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

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1299700
UMLS CUI [1,4]
C0566251
Specify
Description

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

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1299700
UMLS CUI [1,4]
C0566251
Was cycle 3, day 8 dose reduced?
Description

Experimental drug, Dosage, Dose Reduced

Data type

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1707814
If Yes, check the Primary Reason
Description

Experimental drug, Dosage, Dose Reduced, Reason and justification

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1707814
UMLS CUI [1,4]
C0566251
Specify
Description

Experimental drug, Dosage, Dose Reduced, Reason and justification

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1707814
UMLS CUI [1,4]
C0566251
Was cycle 4, day 1 dose delayed?
Description

Experimental drug, Dosage, Delay of drug therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1299700
If Yes, check the Primary Reason
Description

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

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1299700
UMLS CUI [1,4]
C0566251
Specify
Description

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

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1299700
UMLS CUI [1,4]
C0566251
Was cycle 4, day 1 dose reduced?
Description

Experimental drug, Dosage, Dose Reduced

Data type

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1707814
If Yes, check the Primary Reason
Description

Experimental drug, Dosage, Dose Reduced, Reason and justification

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1707814
UMLS CUI [1,4]
C0566251
Specify
Description

Experimental drug, Dosage, Dose Reduced, Reason and justification

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1707814
UMLS CUI [1,4]
C0566251
Was cycle 4, day 8 dose delayed?
Description

Experimental drug, Dosage, Delay of drug therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1299700
Specify
Description

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

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1299700
UMLS CUI [1,4]
C0566251
Was cycle 4, day 8 dose reduced?
Description

Experimental drug, Dosage, Dose Reduced

Data type

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1707814
If Yes, check the Primary Reason
Description

Experimental drug, Dosage, Dose Reduced, Reason and justification

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1707814
UMLS CUI [1,4]
C0566251
Specify
Description

Experimental drug, Dosage, Dose Reduced, Reason and justification

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1707814
UMLS CUI [1,4]
C0566251
Was cycle 5, day 1 dose delayed?
Description

Experimental drug, Dosage, Delay of drug therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1299700
If Yes, check the Primary Reason
Description

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

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1299700
UMLS CUI [1,4]
C0566251
Specify
Description

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

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1299700
UMLS CUI [1,4]
C0566251
Was cycle 5, day 1 dose reduced?
Description

Experimental drug, Dosage, Dose Reduced

Data type

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1707814
If Yes, check the Primary Reason
Description

Experimental drug, Dosage, Dose Reduced, Reason and justification

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1707814
UMLS CUI [1,4]
C0566251
Specify
Description

Experimental drug, Dosage, Dose Reduced, Reason and justification

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1707814
UMLS CUI [1,4]
C0566251
Was cycle 5, day 8 dose delayed?
Description

Experimental drug, Dosage, Delay of drug therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1299700
If Yes, check the Primary Reason
Description

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

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1299700
UMLS CUI [1,4]
C0566251
Specify
Description

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

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1299700
UMLS CUI [1,4]
C0566251
Was cycle 5, day 8 dose reduced?
Description

Experimental drug, Dosage, Dose Reduced

Data type

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1707814
If Yes, check the Primary Reason
Description

Experimental drug, Dosage, Dose Reduced, Reason and justification

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1707814
UMLS CUI [1,4]
C0566251
Specify
Description

Experimental drug, Dosage, Dose Reduced, Reason and justification

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1707814
UMLS CUI [1,4]
C0566251
Was cycle 6, day 1 dose delayed?
Description

Experimental drug, Dosage, Delay of drug therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1299700
If Yes, check the Primary Reason
Description

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

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1299700
UMLS CUI [1,4]
C0566251
Specify
Description

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

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1299700
UMLS CUI [1,4]
C0566251
Was cycle 6, day 1 dose reduced?
Description

Experimental drug, Dosage, Dose Reduced

Data type

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1707814
If Yes, check the Primary Reason
Description

Experimental drug, Dosage, Dose Reduced, Reason and justification

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1707814
UMLS CUI [1,4]
C0566251
Specify
Description

Experimental drug, Dosage, Dose Reduced, Reason and justification

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1707814
UMLS CUI [1,4]
C0566251
Was cycle 6, day 8 dose delayed?
Description

Experimental drug, Dosage, Delay of drug therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1299700
If Yes, check the Primary Reason
Description

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

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1299700
UMLS CUI [1,4]
C0566251
Specify
Description

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

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1299700
UMLS CUI [1,4]
C0566251
Was cycle 6, day 8 dose reduced?
Description

Experimental drug, Dosage, Dose Reduced

Data type

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1707814
If Yes, check the Primary Reason
Description

Experimental drug, Dosage, Dose Reduced, Reason and justification

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1707814
UMLS CUI [1,4]
C0566251
Specify
Description

Experimental drug, Dosage, Dose Reduced, Reason and justification

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1707814
UMLS CUI [1,4]
C0566251
Investigational Product - IV Dosing (Carboplatin)
Description

Investigational Product - IV Dosing (Carboplatin)

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0178602
Cycle Number
Description

Experimental drug, Dosage, chemotherapeutics regimen status cycle number

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C2045829
Day
Description

Experimental drug, Dosage, Day

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0439228
Infusion Start Date
Description

Experimental drug, Dosage, Start Date

Data type

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0808070
Infusion Start Time
Description

Experimental drug, Dosage, Start Time

Data type

time

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1301880
Infusion Stop Date
Description

Experimental drug, Dosage, End Date

Data type

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0806020
Infusion Stop Time
Description

Experimental drug, Dosage, End Time

Data type

time

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1522314
Dose
Description

Experimental drug, Dosage

Data type

integer

Measurement units
  • AUC
Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
AUC
Actual Dose
Description

Experimental drug, Dosage, Actual

Data type

integer

Measurement units
  • mg
Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0237400
mg
Was cycle 2 dose delayed?
Description

Experimental drug, Dosage, Delay of drug therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1299700
If Yes, check the Primary Reason
Description

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

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1299700
UMLS CUI [1,4]
C0566251
Specify
Description

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

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1299700
UMLS CUI [1,4]
C0566251
Was cycle 2 dose reduced?
Description

Experimental drug, Dosage, Dose Reduced

Data type

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1707814
If Yes, check the Primary Reason
Description

Experimental drug, Dosage, Dose Reduced, Reason and justification

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1707814
UMLS CUI [1,4]
C0566251
Specify
Description

Experimental drug, Dosage, Dose Reduced, Reason and justification

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1707814
UMLS CUI [1,4]
C0566251
Was cycle 3 dose delayed?
Description

Experimental drug, Dosage, Delay of drug therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1299700
If Yes, check the Primary Reason
Description

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

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1299700
UMLS CUI [1,4]
C0566251
Specify
Description

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

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1299700
UMLS CUI [1,4]
C0566251
Was cycle 3 dose reduced?
Description

Experimental drug, Dosage, Dose Reduced

Data type

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1707814
If Yes, check the Primary Reason
Description

Experimental drug, Dosage, Dose Reduced, Reason and justification

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1707814
UMLS CUI [1,4]
C0566251
Specify
Description

Experimental drug, Dosage, Dose Reduced, Reason and justification

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1707814
UMLS CUI [1,4]
C0566251
Was cycle 4 dose delayed?
Description

Experimental drug, Dosage, Delay of drug therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1299700
If Yes, check the Primary Reason
Description

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

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1299700
UMLS CUI [1,4]
C0566251
Specify
Description

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

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1299700
UMLS CUI [1,4]
C0566251
Was cycle 4 dose reduced?
Description

Experimental drug, Dosage, Dose Reduced

Data type

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1707814
If Yes, check the Primary Reason
Description

Experimental drug, Dosage, Dose Reduced, Reason and justification

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1707814
UMLS CUI [1,4]
C0566251
Specify
Description

Experimental drug, Dosage, Dose Reduced, Reason and justification

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1707814
UMLS CUI [1,4]
C0566251
Was cycle 5 dose delayed?
Description

Experimental drug, Dosage, Delay of drug therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1299700
If Yes, check the Primary Reason
Description

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

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1299700
UMLS CUI [1,4]
C0566251
Specify
Description

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

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1299700
UMLS CUI [1,4]
C0566251
Was cycle 5 dose reduced?
Description

Experimental drug, Dosage, Dose Reduced

Data type

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1707814
If Yes, check the Primary Reason
Description

Experimental drug, Dosage, Dose Reduced, Reason and justification

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1707814
UMLS CUI [1,4]
C0566251
Specify
Description

Experimental drug, Dosage, Dose Reduced, Reason and justification

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1707814
UMLS CUI [1,4]
C0566251
Was cycle 5 dose delayed?
Description

Experimental drug, Dosage, Delay of drug therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1299700
If Yes, check the Primary Reason
Description

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

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1299700
UMLS CUI [1,4]
C0566251
Specify
Description

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

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1299700
UMLS CUI [1,4]
C0566251
Was cycle 5 dose reduced?
Description

Experimental drug, Dosage, Dose Reduced

Data type

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1707814
If Yes, check the Primary Reason
Description

Experimental drug, Dosage, Dose Reduced, Reason and justification

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1707814
UMLS CUI [1,4]
C0566251
Specify
Description

Experimental drug, Dosage, Dose Reduced, Reason and justification

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1707814
UMLS CUI [1,4]
C0566251
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Similar models

Investigational Product - IV Dosing

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Clinical Trial Subject Unique Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Item Group
Investigational Product - IV Dosing (Hycamtin)
C0304229 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
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)
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])
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)
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])
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])
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)
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])
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)
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])
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])
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)
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])
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])
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)
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])
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])
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)
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])
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])
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])
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])
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)
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])
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])
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)
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])
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])
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)
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])
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])
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)
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])
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])
Item Group
Investigational Product - IV Dosing (Carboplatin)
C0304229 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
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)
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])
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)
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])
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])
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)
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])
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])
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)
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])
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])
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)
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])
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])
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)
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])
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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