ID

37327

Descrizione

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

versioni (1)
  1. 17/07/19 17/07/19 -
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GlaxoSmithKline

Caricato su

17 luglio 2019

DOI

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Licenza

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

Inglese

Serious Adverse Event (SAE)

1 moduli  
Administrative Data
Descrizione

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Descrizione

Clinical Trial Subject Unique Identifier

Tipo di dati

integer

Alias
UMLS CUI [1]
C2348585
Centre Number
Descrizione

Study Coordinating Center, Identification number

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C2825181
UMLS CUI [1,2]
C1300638
Serious Adverse Event (SAE)
Descrizione

Serious Adverse Event (SAE)

Alias
UMLS CUI-1
C1519255
Did the subject experience a serious adverse event during the study?
Descrizione

Serious Adverse Event, During, Clinical Trials

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0008976
Event
Descrizione

Serious Adverse Event

Tipo di dati

text

Alias
UMLS CUI [1]
C1519255
Start Date
Descrizione

Serious Adverse Event, Start Date

Tipo di dati

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0808070
Outcome
Descrizione

Serious Adverse Event, Adverse Event Outcome

Tipo di dati

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1705586
End Date
Descrizione

Serious Adverse Event, End Date

Tipo di dati

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0806020
Maximum Toxicity
Descrizione

Serious Adverse Event, Toxicity Grade

Tipo di dati

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2826262
Action Taken with Investigational Product(s) as a Result of the SAE
Descrizione

Serious Adverse Event, Action Taken with Study Treatment

Tipo di dati

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1704758
Did the subject withdraw from study as a result of this SAE?
Descrizione

Serious Adverse Event, Withdraw

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2349954
Is there a reasonable possibility that the SAE may have been caused by the investigational product?
Descrizione

Serious Adverse Event, Relationships, Experimental drug

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0304229
If fatal, was a post-mortem/autopsy performed?
Descrizione

Serious Adverse Event, Fatal, Autopsy

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1302234
UMLS CUI [1,3]
C0004398
Seriousness
Descrizione

Seriousness

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C1710056
Specify reason(s) for considering this a SAE, check all that apply:
Descrizione

Serious Adverse Event, Seriousness of Adverse Event

Tipo di dati

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1710056
Specify
Descrizione

Serious Adverse Event, Seriousness of Adverse Event

Tipo di dati

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1710056
Specify
Descrizione

Serious Adverse Event, Seriousness of Adverse Event

Tipo di dati

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1710056
Demography Data
Descrizione

Demography Data

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0011298
Date of birth
Descrizione

Patient date of birth

Tipo di dati

date

Alias
UMLS CUI [1]
C0421451
Sex
Descrizione

Gender

Tipo di dati

text

Alias
UMLS CUI [1]
C0079399
Weight
Descrizione

Body Weight

Tipo di dati

float

Unità di misura
  • kg
Alias
UMLS CUI [1]
C0005910
kg
If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
Descrizione

If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0439849
UMLS CUI-3
C0304229
If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
Descrizione

Serious Adverse Event, Relationships, Experimental drug

Tipo di dati

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0304229
Possible Causes of SAE Other Than Investigational Product(s)
Descrizione

Possible Causes of SAE Other Than Investigational Product(s)

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0015127
Possible Causes of SAE Other Than Investigational Product(s), check all that apply
Descrizione

Serious Adverse Event, Etiology aspects

Tipo di dati

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0015127
Specify
Descrizione

Serious Adverse Event, Etiology aspects

Tipo di dati

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0015127
RELEVANT Medical Conditions
Descrizione

RELEVANT Medical Conditions

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0012634
UMLS CUI-3
C2347946
Specify any RELEVANT past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE
Descrizione

Serious Adverse Event, Disease, Relevance

Tipo di dati

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C2347946
Date of Onset
Descrizione

Serious Adverse Event, Disease, Relevance, Start Date

Tipo di dati

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C2347946
UMLS CUI [1,4]
C0808070
Condition Present at Time of the SAE?
Descrizione

Serious Adverse Event, Disease, Relevance, Present

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C2347946
UMLS CUI [1,4]
C0150312
If No, Date of Last Occurrence
Descrizione

Serious Adverse Event, Disease, Relevance, End date

Tipo di dati

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C2347946
UMLS CUI [1,4]
C0806020
Other RELEVANT Risk Factors
Descrizione

Other RELEVANT Risk Factors

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0035648
Provide any family or social history (e.g., smoking, alcohol, diet, drug abuse, occupational hazard) relevant to the SAE
Descrizione

Serious Adverse Event, Risk factors

Tipo di dati

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0035648
RELEVANT Concomitant Medications
Descrizione

RELEVANT Concomitant Medications

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C2347852
Drug Name
Descrizione

Serious Adverse Event, Concomitant Agent, Medication name

Tipo di dati

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C2360065
Dose
Descrizione

Serious Adverse Event, Concomitant Agent, Dosage

Tipo di dati

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0178602
Unit
Descrizione

Serious Adverse Event, Concomitant Agent, Unit of Measure

Tipo di dati

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C1519795
Frequency
Descrizione

Serious Adverse Event, Concomitant Agent, Frequencies

Tipo di dati

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0439603
Route
Descrizione

Serious Adverse Event, Concomitant Agent, Drug Administration Routes

Tipo di dati

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0013153
Taken Prior to Study?
Descrizione

Serious Adverse Event, Concomitant Medication Previous Occurrence

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2826667
Start Date
Descrizione

Serious Adverse Event, Concomitant Medication Start Date

Tipo di dati

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2826734
Stop Date
Descrizione

Serious Adverse Event, Concomitant Medication End Date

Tipo di dati

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2826744
Ongoing Medication?
Descrizione

Serious Adverse Event, Concomitant Medication Ongoing

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2826666
Reason for Medication
Descrizione

Serious Adverse Event, Concomitant Agent, Indication

Tipo di dati

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0392360
Details of Investigational Product(s)
Descrizione

Details of Investigational Product(s)

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0304229
Investigational Product
Descrizione

Serious Adverse Event, Experimental drug

Tipo di dati

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
Day
Descrizione

Serious Adverse Event, Experimental drug, Study Day

Tipo di dati

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C2826182
Cycle 1 - Date
Descrizione

Serious Adverse Event, Experimental drug, Date in time

Tipo di dati

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0011008
Cycle 1 - Dose
Descrizione

Serious Adverse Event, Experimental drug, Dosage

Tipo di dati

float

Unità di misura
  • mg/m2
Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0178602
mg/m2
Cycle 1 - Actual Dose
Descrizione

Serious Adverse Event, Experimental drug, Dosage, Actual

Tipo di dati

float

Unità di misura
  • mg
Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0178602
UMLS CUI [1,4]
C0237400
mg
Relevant Cycle - Cycle Number
Descrizione

Serious Adverse Event, Experimental drug, Course, Relevance

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0750729
UMLS CUI [1,4]
C2347946
Relevant Cycle - Date
Descrizione

Serious Adverse Event, Experimental drug, Date in time

Tipo di dati

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0011008
Relevant Cycle - Dose
Descrizione

Serious Adverse Event, Experimental drug, Dosage

Tipo di dati

float

Unità di misura
  • AUC or mg/m2
Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0178602
AUC or mg/m2
Relevant Cycle - Actual Dose
Descrizione

Serious Adverse Event, Experimental drug, Dosage, Actual

Tipo di dati

float

Unità di misura
  • mg
Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0178602
UMLS CUI [1,4]
C0237400
mg
Relevant Cycle - Cumulative Dose
Descrizione

Serious Adverse Event, Experimental drug, Cumulative Dose

Tipo di dati

float

Unità di misura
  • mg
Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C2986497
mg
Details of relevant Assessments
Descrizione

Details of relevant Assessments

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0220825
Provide details of any other tests/procedures which were carried out to diagnose or confirm the SAE e.g., laboratory data with units and normal range.
Descrizione

Serious Adverse Event, Evaluation

Tipo di dati

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0220825
Narrative Remarks
Descrizione

Narrative Remarks

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0947611
Provide a brief narrative description of the SAE and details of treatment given.
Descrizione

Serious Adverse Event, Comment

Tipo di dati

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0947611
Investigator's Signature
Descrizione

Investigator's Signature

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C2346576
Investigator’s signature (confirming that the data on the SAE pages are accurate and complete)
Descrizione

Serious Adverse Event, Investigator Signature

Tipo di dati

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2346576
Date
Descrizione

Serious Adverse Event, Investigator Signature, Date in time

Tipo di dati

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2346576
UMLS CUI [1,3]
C0011008
Investigator’s name
Descrizione

Serious Adverse Event, Investigator Name

Tipo di dati

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2826892
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Similar models

Serious Adverse Event (SAE)

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Clinical Trial Subject Unique Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Study Coordinating Center, Identification number
Item
Centre Number
integer
C2825181 (UMLS CUI [1,1])
C1300638 (UMLS CUI [1,2])
Item Group
Serious Adverse Event (SAE)
C1519255 (UMLS CUI-1)
Serious Adverse Event, During, Clinical Trials
Item
Did the subject experience a serious adverse event during the study?
boolean
C1519255 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Serious Adverse Event
Item
Event
text
C1519255 (UMLS CUI [1])
Serious Adverse Event, Start Date
Item
Start Date
date
C1519255 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Item
Outcome
text
C1519255 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Gender
Code List
Outcome
CL Item
Male (1)
CL Item
Female (2)
Serious Adverse Event, End Date
Item
End Date
date
C1519255 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Maximum Toxicity
text
C1519255 (UMLS CUI [1,1])
C2826262 (UMLS CUI [1,2])
Serious Adverse Event, Etiology aspects
Code List
Maximum Toxicity
CL Item
Disease under study (1)
CL Item
Medical condition(s)  (2)
CL Item
Lack of efficacy (3)
CL Item
Withdrawal of investigational product(s) (4)
CL Item
Concomitant medication  (5)
CL Item
Activity related to study participation (e.g., procedures)  (6)
CL Item
Other, specify (7)
Item
Action Taken with Investigational Product(s) as a Result of the SAE
text
C1519255 (UMLS CUI [1,1])
C1704758 (UMLS CUI [1,2])
Serious Adverse Event, Etiology aspects
Code List
Action Taken with Investigational Product(s) as a Result of the SAE
CL Item
Disease under study (1)
CL Item
Medical condition(s)  (2)
CL Item
Lack of efficacy (3)
CL Item
Withdrawal of investigational product(s) (4)
CL Item
Concomitant medication  (5)
CL Item
Activity related to study participation (e.g., procedures)  (6)
CL Item
Other, specify (7)
Serious Adverse Event, Withdraw
Item
Did the subject withdraw from study as a result of this SAE?
boolean
C1519255 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
Serious Adverse Event, Relationships, Experimental drug
Item
Is there a reasonable possibility that the SAE may have been caused by the investigational product?
boolean
C1519255 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Serious Adverse Event, Fatal, Autopsy
Item
If fatal, was a post-mortem/autopsy performed?
boolean
C1519255 (UMLS CUI [1,1])
C1302234 (UMLS CUI [1,2])
C0004398 (UMLS CUI [1,3])
Item Group
Seriousness
C1519255 (UMLS CUI-1)
C1710056 (UMLS CUI-2)
Item
Specify reason(s) for considering this a SAE, check all that apply:
text
C1519255 (UMLS CUI [1,1])
C1710056 (UMLS CUI [1,2])
Serious Adverse Event, Experimental drug
Code List
Specify reason(s) for considering this a SAE, check all that apply:
CL Item
Hycamtin  (1)
CL Item
Hycamtin  (2)
CL Item
Carboplatin (3)
Serious Adverse Event, Seriousness of Adverse Event
Item
Specify
text
C1519255 (UMLS CUI [1,1])
C1710056 (UMLS CUI [1,2])
Serious Adverse Event, Seriousness of Adverse Event
Item
Specify
text
C1519255 (UMLS CUI [1,1])
C1710056 (UMLS CUI [1,2])
Item Group
Demography Data
C1519255 (UMLS CUI-1)
C0011298 (UMLS CUI-2)
Patient date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Gender
Code List
Sex
CL Item
Male (1)
CL Item
Female (2)
Body Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Item Group
If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
C1519255 (UMLS CUI-1)
C0439849 (UMLS CUI-2)
C0304229 (UMLS CUI-3)
Item
If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
text
C1519255 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Serious Adverse Event, Relationships, Experimental drug
Code List
If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
CL Item
Yes  (1)
CL Item
No  (2)
CL Item
Unknown at this time  (3)
CL Item
Not applicable (4)
Item Group
Possible Causes of SAE Other Than Investigational Product(s)
C1519255 (UMLS CUI-1)
C0015127 (UMLS CUI-2)
Item
Possible Causes of SAE Other Than Investigational Product(s), check all that apply
text
C1519255 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
Serious Adverse Event, Etiology aspects
Code List
Possible Causes of SAE Other Than Investigational Product(s), check all that apply
CL Item
Disease under study (1)
CL Item
Medical condition(s)  (2)
CL Item
Lack of efficacy (3)
CL Item
Withdrawal of investigational product(s) (4)
CL Item
Concomitant medication  (5)
CL Item
Activity related to study participation (e.g., procedures)  (6)
CL Item
Other, specify (7)
Serious Adverse Event, Etiology aspects
Item
Specify
text
C1519255 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
Item Group
RELEVANT Medical Conditions
C1519255 (UMLS CUI-1)
C0012634 (UMLS CUI-2)
C2347946 (UMLS CUI-3)
Serious Adverse Event, Disease, Relevance
Item
Specify any RELEVANT past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE
text
C1519255 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C2347946 (UMLS CUI [1,3])
Serious Adverse Event, Disease, Relevance, Start Date
Item
Date of Onset
date
C1519255 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C2347946 (UMLS CUI [1,3])
C0808070 (UMLS CUI [1,4])
Serious Adverse Event, Disease, Relevance, Present
Item
Condition Present at Time of the SAE?
boolean
C1519255 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C2347946 (UMLS CUI [1,3])
C0150312 (UMLS CUI [1,4])
Serious Adverse Event, Disease, Relevance, End date
Item
If No, Date of Last Occurrence
date
C1519255 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C2347946 (UMLS CUI [1,3])
C0806020 (UMLS CUI [1,4])
Item Group
Other RELEVANT Risk Factors
C1519255 (UMLS CUI-1)
C0035648 (UMLS CUI-2)
Serious Adverse Event, Risk factors
Item
Provide any family or social history (e.g., smoking, alcohol, diet, drug abuse, occupational hazard) relevant to the SAE
text
C1519255 (UMLS CUI [1,1])
C0035648 (UMLS CUI [1,2])
Item Group
RELEVANT Concomitant Medications
C1519255 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
Serious Adverse Event, Concomitant Agent, Medication name
Item
Drug Name
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2360065 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, Dosage
Item
Dose
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, Unit of Measure
Item
Unit
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, Frequencies
Item
Frequency
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, Drug Administration Routes
Item
Route
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Medication Previous Occurrence
Item
Taken Prior to Study?
boolean
C1519255 (UMLS CUI [1,1])
C2826667 (UMLS CUI [1,2])
Serious Adverse Event, Concomitant Medication Start Date
Item
Start Date
date
C1519255 (UMLS CUI [1,1])
C2826734 (UMLS CUI [1,2])
Serious Adverse Event, Concomitant Medication End Date
Item
Stop Date
date
C1519255 (UMLS CUI [1,1])
C2826744 (UMLS CUI [1,2])
Serious Adverse Event, Concomitant Medication Ongoing
Item
Ongoing Medication?
boolean
C1519255 (UMLS CUI [1,1])
C2826666 (UMLS CUI [1,2])
Serious Adverse Event, Concomitant Agent, Indication
Item
Reason for Medication
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Item Group
Details of Investigational Product(s)
C1519255 (UMLS CUI-1)
C0304229 (UMLS CUI-2)
Item
Investigational Product
text
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Serious Adverse Event, Experimental drug
Code List
Investigational Product
CL Item
Hycamtin  (1)
CL Item
Hycamtin  (2)
CL Item
Carboplatin (3)
Item
Day
text
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C2826182 (UMLS CUI [1,3])
Serious Adverse Event, Experimental drug
Code List
Day
CL Item
1  (1)
CL Item
8  (2)
CL Item
1 (3)
Serious Adverse Event, Experimental drug, Date in time
Item
Cycle 1 - Date
date
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Serious Adverse Event, Experimental drug, Dosage
Item
Cycle 1 - Dose
float
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
Serious Adverse Event, Experimental drug, Dosage, Actual
Item
Cycle 1 - Actual Dose
float
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0237400 (UMLS CUI [1,4])
Serious Adverse Event, Experimental drug, Course, Relevance
Item
Relevant Cycle - Cycle Number
integer
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0750729 (UMLS CUI [1,3])
C2347946 (UMLS CUI [1,4])
Serious Adverse Event, Experimental drug, Date in time
Item
Relevant Cycle - Date
date
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Serious Adverse Event, Experimental drug, Dosage
Item
Relevant Cycle - Dose
float
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
Serious Adverse Event, Experimental drug, Dosage, Actual
Item
Relevant Cycle - Actual Dose
float
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0237400 (UMLS CUI [1,4])
Serious Adverse Event, Experimental drug, Cumulative Dose
Item
Relevant Cycle - Cumulative Dose
float
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C2986497 (UMLS CUI [1,3])
Item Group
Details of relevant Assessments
C1519255 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
Serious Adverse Event, Evaluation
Item
Provide details of any other tests/procedures which were carried out to diagnose or confirm the SAE e.g., laboratory data with units and normal range.
text
C1519255 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
Item Group
Narrative Remarks
C1519255 (UMLS CUI-1)
C0947611 (UMLS CUI-2)
Serious Adverse Event, Comment
Item
Provide a brief narrative description of the SAE and details of treatment given.
text
C1519255 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item Group
Investigator's Signature
C1519255 (UMLS CUI-1)
C2346576 (UMLS CUI-2)
Serious Adverse Event, Investigator Signature
Item
Investigator’s signature (confirming that the data on the SAE pages are accurate and complete)
text
C1519255 (UMLS CUI [1,1])
C2346576 (UMLS CUI [1,2])
Serious Adverse Event, Investigator Signature, Date in time
Item
Date
date
C1519255 (UMLS CUI [1,1])
C2346576 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Serious Adverse Event, Investigator Name
Item
Investigator’s name
text
C1519255 (UMLS CUI [1,1])
C2826892 (UMLS CUI [1,2])
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