ID

37327

Beschreibung

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

Stichworte

Versionen (1)
  1. 17.07.19 17.07.19 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

17. Juli 2019

DOI

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HYCAMTIN in Combination With Carboplatin in Subjects with Ovarian Cancer; NCT00316173

Englisch

Serious Adverse Event (SAE)

1 Formulare  
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beschreibung

Clinical Trial Subject Unique Identifier

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Centre Number
Beschreibung

Study Coordinating Center, Identification number

Datentyp

integer

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

Serious Adverse Event (SAE)

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

Serious Adverse Event, During, Clinical Trials

Datentyp

boolean

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

Serious Adverse Event

Datentyp

text

Alias
UMLS CUI [1]
C1519255
Start Date
Beschreibung

Serious Adverse Event, Start Date

Datentyp

date

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

Serious Adverse Event, Adverse Event Outcome

Datentyp

text

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

Serious Adverse Event, End Date

Datentyp

date

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

Serious Adverse Event, Toxicity Grade

Datentyp

text

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

Serious Adverse Event, Action Taken with Study Treatment

Datentyp

text

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

Serious Adverse Event, Withdraw

Datentyp

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?
Beschreibung

Serious Adverse Event, Relationships, Experimental drug

Datentyp

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?
Beschreibung

Serious Adverse Event, Fatal, Autopsy

Datentyp

boolean

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

Seriousness

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

Serious Adverse Event, Seriousness of Adverse Event

Datentyp

text

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

Serious Adverse Event, Seriousness of Adverse Event

Datentyp

text

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

Serious Adverse Event, Seriousness of Adverse Event

Datentyp

text

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

Demography Data

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

Patient date of birth

Datentyp

date

Alias
UMLS CUI [1]
C0421451
Sex
Beschreibung

Gender

Datentyp

text

Alias
UMLS CUI [1]
C0079399
Weight
Beschreibung

Body Weight

Datentyp

float

Maßeinheiten
  • 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?
Beschreibung

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?
Beschreibung

Serious Adverse Event, Relationships, Experimental drug

Datentyp

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)
Beschreibung

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
Beschreibung

Serious Adverse Event, Etiology aspects

Datentyp

text

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

Serious Adverse Event, Etiology aspects

Datentyp

text

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

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
Beschreibung

Serious Adverse Event, Disease, Relevance

Datentyp

text

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

Serious Adverse Event, Disease, Relevance, Start Date

Datentyp

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?
Beschreibung

Serious Adverse Event, Disease, Relevance, Present

Datentyp

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
Beschreibung

Serious Adverse Event, Disease, Relevance, End date

Datentyp

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
Beschreibung

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
Beschreibung

Serious Adverse Event, Risk factors

Datentyp

text

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

RELEVANT Concomitant Medications

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

Serious Adverse Event, Concomitant Agent, Medication name

Datentyp

text

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

Serious Adverse Event, Concomitant Agent, Dosage

Datentyp

text

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

Serious Adverse Event, Concomitant Agent, Unit of Measure

Datentyp

text

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

Serious Adverse Event, Concomitant Agent, Frequencies

Datentyp

text

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

Serious Adverse Event, Concomitant Agent, Drug Administration Routes

Datentyp

text

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

Serious Adverse Event, Concomitant Medication Previous Occurrence

Datentyp

boolean

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

Serious Adverse Event, Concomitant Medication Start Date

Datentyp

date

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

Serious Adverse Event, Concomitant Medication End Date

Datentyp

date

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

Serious Adverse Event, Concomitant Medication Ongoing

Datentyp

boolean

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

Serious Adverse Event, Concomitant Agent, Indication

Datentyp

text

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

Details of Investigational Product(s)

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

Serious Adverse Event, Experimental drug

Datentyp

text

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

Serious Adverse Event, Experimental drug, Study Day

Datentyp

text

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

Serious Adverse Event, Experimental drug, Date in time

Datentyp

date

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

Serious Adverse Event, Experimental drug, Dosage

Datentyp

float

Maßeinheiten
  • mg/m2
Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0178602
mg/m2
Cycle 1 - Actual Dose
Beschreibung

Serious Adverse Event, Experimental drug, Dosage, Actual

Datentyp

float

Maßeinheiten
  • 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
Beschreibung

Serious Adverse Event, Experimental drug, Course, Relevance

Datentyp

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
Beschreibung

Serious Adverse Event, Experimental drug, Date in time

Datentyp

date

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

Serious Adverse Event, Experimental drug, Dosage

Datentyp

float

Maßeinheiten
  • 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
Beschreibung

Serious Adverse Event, Experimental drug, Dosage, Actual

Datentyp

float

Maßeinheiten
  • 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
Beschreibung

Serious Adverse Event, Experimental drug, Cumulative Dose

Datentyp

float

Maßeinheiten
  • mg
Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C2986497
mg
Details of relevant Assessments
Beschreibung

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.
Beschreibung

Serious Adverse Event, Evaluation

Datentyp

text

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

Narrative Remarks

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

Serious Adverse Event, Comment

Datentyp

text

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

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)
Beschreibung

Serious Adverse Event, Investigator Signature

Datentyp

text

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

Serious Adverse Event, Investigator Signature, Date in time

Datentyp

date

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

Serious Adverse Event, Investigator Name

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2826892
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Ähnliche Modelle

Serious Adverse Event (SAE)

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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