ID

27314

Beschrijving

Original CRFs from: K.Afshar, J. Bleidorn, E. Hummers-Pradier, I. Gágyor. Further details on: http://www.allgemeinmedizin.med.uni-goettingen.de/en/content/research/510_520.html https://clinicaltrials.gov/ct2/show/NCT03151603 Questionnaire Day 28

Link

http://www.allgemeinmedizin.med.uni-goettingen.de/en/content/research/510_520.html

Trefwoorden

07-11-17 07-11-17 -

Houder van rechten

K.Afshar, J. Bleidorn, E. Hummers-Pradier, I. Gágyor

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7 november 2017

DOI

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Licentie

Creative Commons BY-NC-ND 3.0

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Questionnaire Day 28 REGATTA NCT03151603

model
Details

Questionnaire Day 28 REGATTA NCT03151603

1 Formulieren

StudyEvent: ODM
1. Questionnaire Day 28 REGATTA NCT03151603

Name

Type

Description | Question | Decode (Coded Value)

Datatype

Alias

General Information

Item Group

General Information

C1508263 (UMLS CUI-1)

Visit Date

Item

Filled in (Date):

date

Previous Urinary Tract Infection

Item Group

Previous Urinary Tract Infection

C0205156 (UMLS CUI-1)
C0042029 (UMLS CUI-2)

Previous Urinary Tract Infection

Item

1. Did you have one or more urinary tract infection in the last three weeks?

boolean

C0205156 (UMLS CUI [1,1])
C0042029 (UMLS CUI [1,2])

Numbers of Previous Urinary Tract Infection

Item

1a. If YES, how many urinary tract or bladder infections did you have in the last three weeks? (Please specify the number:)

text

C0449788 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0042029 (UMLS CUI [1,3])

Urinary Tract Infection: Sick Leave

Item

1b. Have you been on sick leave due to an urinary tract infection in the last 4 weeks (since the beginning of the study)?

boolean

C0242807 (UMLS CUI [1,1])
C0042029 (UMLS CUI [1,2])

Urinary Tract Infection: Sick Leave Specification

Item

1b. Have you been on sick leave due to an urinary tract infection in the last 4 weeks (since the beginning of the study)? If YES, specify the number of days:

float

C0242807 (UMLS CUI [1,1])
C0042029 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])

Urinary Tract Infection: Start Date

Item

1c. When was your last urinary tract infection (in the last 3 weeks)? Start Date:

date

C0042029 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])

Urinary Tract Infection: End Date

Item

1c. When was your last urinary tract infection (in the last 3 weeks)? End Date:

date

C0042029 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])

Urinary Tract Infection: Office Visit

Item

1d. Did you went to your general practitioner or another doctor because of your last urinary tract infection?

boolean

C0042029 (UMLS CUI [1,1])
C0028900 (UMLS CUI [1,2])

Urinary Tract Infection: Physicians

Item

1d1. If YES, who provided medical care? (several answers are possible)

text

C0042029 (UMLS CUI [1,1])
C0031831 (UMLS CUI [1,2])

Urinary Tract Infection: Physicians

Code List

1d1. If YES, who provided medical care? (several answers are possible)

CL Item

(durch den Hausarzt)

CL Item

(durch den Facharzt)

CL Item

(in der Notfallambulanz)

Urinary Tract Infection: Febrile Infection

Item

1d2. Had fever (>38°C) occurred in the course of this urinary tract infection?

boolean

C0042029 (UMLS CUI [1,1])
C0948233 (UMLS CUI [1,2])

Pharmacotherapy

Item Group

Pharmacotherapy - If you have a further urinary tract infection, continue on page 3. If you have further health problems/issues continue on page 4.

C0013216 (UMLS CUI-1)

Pharmacotherapy

Item

2. Have you taken any medication (antibiotics, analgesics, other medication, herbal drugs) for an urinary tract infection in the last 3 weeks?

boolean

C0013216 (UMLS CUI [1])

Antibiotics

Item

Antibiotics: Drug Name (e.g. Cefuroxim)

text

C0003232 (UMLS CUI [1])

Antibiotics: Dosage

Item

Antibiotics: Dosage (e.g. 500 mg)

text

C0003232 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])

Antibiotics: Medication Frequency

Item

Antibiotics: Medication Frequency (e.g. 2x1 tablets)

text

C0003232 (UMLS CUI [1,1])
C3476109 (UMLS CUI [1,2])

Antibiotics: Start Date

Item

Antibiotics: Start Date

date

C0003232 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])

Antibiotics: End Date

Item

Antibiotics: End Date

date

C0003232 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])

Analgesics

Item

Analgesics: Drug Name

text

C0002771 (UMLS CUI [1])

Analgesics: Dosage

Item

Analgesics: Dosage (e.g. 500 mg)

text

C0002771 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])

Analgesics: Medication Frequency

Item

Analgesics: Medication Frequency (e.g. 2x1 tablets)

text

C0002771 (UMLS CUI [1,1])
C3476109 (UMLS CUI [1,2])

Analgesics: Start Date

Item

Analgesics: Start Date

date

C0002771 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])

Anagesics: End Date

Item

Analgesics: End Date

date

C0002771 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])

Other Medication

Item

Other Medication: Drug Name

text

C1115771 (UMLS CUI [1])

Other Medication: Dosage

Item

Other Medication: Dosage (e.g. 500 mg)

text

C1115771 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])

Other Medication: Medication Frequency

Item

Other Medication: Medication Frequency (e.g. 2x1 tablets)

text

C1115771 (UMLS CUI [1,1])
C3476109 (UMLS CUI [1,2])

Other Medication: Start Date

Item

Other Medication: Start Date

date

C1115771 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])

Other Medication: End Date

Item

Other Medication: End Date

date

C1115771 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])

Further Urinary Tract Infection

Item Group

Further Urinary Tract Infection

C0042029 (UMLS CUI-1)
C1517331 (UMLS CUI-2)

Further Urinary Tract Infection

Item

3. Did you have a further urinary tract infection in the last three weeks?

boolean

C0042029 (UMLS CUI [1,1])
C1517331 (UMLS CUI [1,2])

Date of Further Urinary Tract Infection

Item

3a. Date of further Urinary Tract Infection?

date

C0011008 (UMLS CUI [1,1])
C0042029 (UMLS CUI [1,2])
C1517331 (UMLS CUI [1,3])

Further Urinary Tract Infection: Office Visit

Item

3b. Did you went to your general practitioner or another doctor because of further urinary tract infection?

boolean

C1517331 (UMLS CUI [1,1])
C0042029 (UMLS CUI [1,2])
C0028900 (UMLS CUI [1,3])

Further Urinary Tract Infection: Physicians

Item

3b1. If YES, who provided medical care? (several answers are possible)

text

C1517331 (UMLS CUI [1,1])
C0042029 (UMLS CUI [1,2])
C0031831 (UMLS CUI [1,3])

Urinary Tract Infection: Physicians

Code List

3b1. If YES, who provided medical care? (several answers are possible)

CL Item

(durch den Hausarzt)

CL Item

(durch den Facharzt)

CL Item

(in der Notfallambulanz)

Further Urinary Tract Infection: Febrile Infection

Item

3b2. Had fever (>38°C) occurred in the course of this urinary tract infection?

boolean

C1517331 (UMLS CUI [1,1])
C0042029 (UMLS CUI [1,2])
C0948233 (UMLS CUI [1,3])

Pharmacotherapy: Further Urinary Tract Infection

Item Group

Pharmacotherapy: Further Urinary Tract Infection

C0013216 (UMLS CUI-1)
C0042029 (UMLS CUI-2)
C1517331 (UMLS CUI-3)

Further Pharmacotherapy

Item

4. Have you taken any medication (antibiotics, analgesics, other medication, herbal drugs) for this further urinary tract infection?

boolean

C0013216 (UMLS CUI [1,1])
C1517331 (UMLS CUI [1,2])

Further Antibiotics

Item

Antibiotics: Drug Name (e.g. Cefuroxim)

text

C0003232 (UMLS CUI [1,1])
C1517331 (UMLS CUI [1,2])

Further Antibiotics: Dosage

Item

Antibiotics: Dosage (e.g. 500 mg)

text

C0003232 (UMLS CUI [1,1])
C1517331 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])

Further Antibiotics: Medication Frequency

Item

Antibiotics: Medication Frequency (e.g. 2x1 tablets)

text

C0003232 (UMLS CUI [1,1])
C1517331 (UMLS CUI [1,2])
C3476109 (UMLS CUI [1,3])

Further Antibiotics: Start Date

Item

Antibiotics: Start Date

date

C0003232 (UMLS CUI [1,1])
C1517331 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])

Further Antibiotics: End Date

Item

Antibiotics: End Date

date

C0003232 (UMLS CUI [1,1])
C1517331 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])

Further Analgesics

Item

Analgesics: Drug Name

text

C0002771 (UMLS CUI [1,1])
C1517331 (UMLS CUI [1,2])

Further Analgesics: Dosage

Item

Analgesics: Dosage (e.g. 500 mg)

text

C0002771 (UMLS CUI [1,1])
C1517331 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])

Further Analgesics: Medication Frequency

Item

Analgesics: Medication Frequency (e.g. 2x1 tablets)

text

C0002771 (UMLS CUI [1,1])
C1517331 (UMLS CUI [1,2])
C3476109 (UMLS CUI [1,3])

Further Analgesics: Start Date

Item

Analgesics: Start Date

date

C0002771 (UMLS CUI [1,1])
C1517331 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])

Further Anagesics: End Date

Item

Analgesics: End Date

date

C0002771 (UMLS CUI [1,1])
C1517331 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])

Further Other Medication

Item

Other Medication: Drug Name

text

C1115771 (UMLS CUI [1,1])
C1517331 (UMLS CUI [1,2])

Further Other Medication: Dosage

Item

Other Medication: Dosage (e.g. 500 mg)

text

C1115771 (UMLS CUI [1,1])
C1517331 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])

Further Other Medication: Medication Frequency

Item

Other Medication: Medication Frequency (e.g. 2x1 tablets)

text

C1115771 (UMLS CUI [1,1])
C1517331 (UMLS CUI [1,2])
C3476109 (UMLS CUI [1,3])

Further Other Medication: Start Date

Item

Other Medication: Start Date

date

C1115771 (UMLS CUI [1,1])
C1517331 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])

Further Other Medication: End Date

Item

Other Medication: End Date

date

C1115771 (UMLS CUI [1,1])
C1517331 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])

Further Symptoms

Item Group

Further Symptoms - On the following pages we ask you for information on further symptoms since study inclusion. Please use a new page for each symptome complex. Symptoms with which you have visited your general physician do not have to be noted.

C1457887 (UMLS CUI-1)

Further Symptoms

Item

5. Did you have a further symptoms since study inclusion?

boolean

C1457887 (UMLS CUI [1])

Further Symptoms: Specification

Item

5a. If YES, please specify your symptoms.

text

C1457887 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])

Further Symptoms: Start Date

Item

5b. When did your symptoms occur? Start Date

date

C1457887 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])

Further Symptoms: End Date

Item

5b. When did your symptoms occur? End Date

date

C1457887 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])

Affected by Further Symptoms

Item

5c. How much have you been affected by the described symptoms in your everyday life?

text

C1457887 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])

Affected by Further Symptoms

Code List

5c. How much have you been affected by the described symptoms in your everyday life?

CL Item

(leicht: normale Aktivitäten des täglichen Lebens werden nicht beeinträchtigt)

CL Item

(mittel: normale Aktivitäten des täglichen Lebens werden störend beeinträchtigt)

CL Item

(schwer: verhindert Aktivitäten des täglichen Lebens)

Further Symptoms: Office Visit

Item

5d. Did you went to your general practitioner or another doctor because of the described symptoms?

boolean

C1457887 (UMLS CUI [1,1])
C0028900 (UMLS CUI [1,2])

Further Symptoms: Physicians

Item

5d1. If YES, who provided medical care? (several answers are possible)

text

C1457887 (UMLS CUI [1,1])
C0031831 (UMLS CUI [1,2])

Urinary Tract Infection: Physicians

Code List

5d1. If YES, who provided medical care? (several answers are possible)

CL Item

(durch den Hausarzt)

CL Item

(durch den Facharzt)

CL Item

(in der Notfallambulanz)

Further Symptoms: Treatment

Item

5d2. Specify the treatment. (several answers are possible)

text

C1457887 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])

Further Symptoms: Treatment

Code List

5d2. Specify the treatment. (several answers are possible)

CL Item

(Keine Maßnahmen)

CL Item

(neue Medikamente)

CL Item

(Krankmeldung)

CL Item

(weitere Diagnostik)

CL Item

(Studienmedikation abgesetzt)

CL Item

(stationäre Aufnahme)

CL Item

(Überweisung)

CL Item

(sonstiges)

Further Symptoms: Referral

Item

5d2. Specify the treatment. If REFERRAL, please specify.

text

C1457887 (UMLS CUI [1,1])
C0034927 (UMLS CUI [1,2])

Further Symptoms: Treatment Specification

Item

5d2. Specify the treatment. If OTHER, please specify.

text

C1457887 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])

Pharmacotherapy: Further Symptoms

Item Group

Pharmacotherapy: Further Symptoms - Please note every medication you have taken for this symptom.

C0013216 (UMLS CUI-1)
C1457887 (UMLS CUI-2)

Antibiotics

Item

Antibiotics: Drug Name (e.g. Cefuroxim)

text

C0003232 (UMLS CUI [1])

Antibiotics: Dosage

Item

Antibiotics: Dosage (e.g. 500 mg)

text

C0003232 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])

Antibiotics: Medication Frequency

Item

Antibiotics: Medication Frequency (e.g. 2x1 tablets)

text

C0003232 (UMLS CUI [1,1])
C3476109 (UMLS CUI [1,2])

Antibiotics: Start Date

Item

Antibiotics: Start Date

date

C0003232 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])

Antibiotics: End Date

Item

Antibiotics: End Date

date

C0003232 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])

Analgesics

Item

Analgesics: Drug Name

text

C0002771 (UMLS CUI [1])

Analgesics: Dosage

Item

Analgesics: Dosage (e.g. 500 mg)

text

C0002771 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])

Analgesics: Medication Frequency

Item

Analgesics: Medication Frequency (e.g. 2x1 tablets)

text

C0002771 (UMLS CUI [1,1])
C3476109 (UMLS CUI [1,2])

Analgesics: Start Date

Item

Analgesics: Start Date

date

C0002771 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])

Anagesics: End Date

Item

Analgesics: End Date

date

C0002771 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])

Other Medication

Item

Other Medication: Drug Name

text

C1115771 (UMLS CUI [1])

Other Medication: Dosage

Item

Other Medication: Dosage (e.g. 500 mg)

text

C1115771 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])

Other Medication: Medication Frequency

Item

Other Medication: Medication Frequency (e.g. 2x1 tablets)

text

C1115771 (UMLS CUI [1,1])
C3476109 (UMLS CUI [1,2])

Other Medication: Start Date

Item

Other Medication: Start Date

date

C1115771 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])

Other Medication: End Date

Item

Other Medication: End Date

date

C1115771 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])

Study Medication

Item Group

Study Medication

C0304229 (UMLS CUI-1)

Study Medication Completed

Item

Study Medication fully completed?

boolean

C2826299 (UMLS CUI [1])

Adverse Event

Item Group

Adverse Event

C0877248 (UMLS CUI-1)

Adverse Event Symptom

Item

Symptoms of Adverse Event

text

C0877248 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])

Adverse Event Diagnosis

Item

Diagnosis of Adverse Event

text

C0877248 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])

Adverse Event ICD-10-Code

Item

ICD-10-Code

text

C2598420 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])

Adverse Event: Start Date

Item

Start Date

date

C2697888 (UMLS CUI [1])

Adverse Event: End Date

Item

End Date

date

C2697886 (UMLS CUI [1])

Adverse Event: Ongoing

Item

Ongoing?

boolean

C2826663 (UMLS CUI [1])

Serious Adverse Event

Item

Is a SAE present?

text

C1519255 (UMLS CUI [1])

Serious Adverse Event

Code List

Is a SAE present?

CL Item

(wiederhergestellt)

CL Item

(noch nicht wiederhergestellt)

CL Item

(bleibender Schaden)

CL Item

(Patientin verstorben (Bitte SAE melden))

CL Item

(unbekannt)

Adverse Event Outcome

Item

Outcome of Adverse Event

text

C1705586 (UMLS CUI [1])

Adverse Event Outcome

Code List

Outcome of Adverse Event

CL Item

(wiederhergestellt)

CL Item

(noch nicht wiederhergestellt)

CL Item

(bleibender Schaden)

CL Item

(Patientin verstorben (Bitte SAE melden))

CL Item

(unbekannt)

Severity of Adverse Event

Item

Severity of Adverse Event

text

C1710066 (UMLS CUI [1])

Severity of Adverse Event

Code List

Severity of Adverse Event

CL Item

(leicht: normale Aktivitäten des täglichen Lebens werden nicht beeinträchtigt)

CL Item

(mittel: normale Aktivitäten des täglichen Lebens werden störend beeinträchtigt)

CL Item

(schwer: verhindert Aktivitäten des täglichen Lebens)

Adverse Event Action Taken

Item

Action Taken

text

C2826626 (UMLS CUI [1])

Adverse Event Action Taken

Code List

Action Taken

CL Item

(keine)

CL Item

(Prüfmedikation abgesetzt)

CL Item

(neue Begleitmedikation)

CL Item

(weitere Diagnostik)

CL Item

(Krankmeldung)

CL Item

(stationäre Aufnahme)

CL Item

(anderwertige medizinische Versorgung)

Concomitant Medication: Pharmaceutical Preparations

Item

If Action Taken with Concomitant Medication, specify: Substance

text

C2347852 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])

Concomitant Medication: Daily Dosage

Item

If Action Taken with Concomitant Medication, specify: Daily Dosage

text

C0178602 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])

Relation to Fosfomycin

Item

Any relation to intake of fosfomycin?

text

C0439849 (UMLS CUI [1,1])
C0016610 (UMLS CUI [1,2])

Relation to Fosfomycin

Code List

Any relation to intake of fosfomycin?

CL Item

(gesichert)

CL Item

(wahrscheinlich)

CL Item

(möglich)

CL Item

(unwahrscheinlich)

CL Item

(ausgeschlossen)

CL Item

(nicht abschätzbar)

Relation to Bearberry preparation

Item

Any relation to intake of Arctuvan (Bearberry preparation)

text

C0439849 (UMLS CUI [1,1])
C0885849 (UMLS CUI [1,2])

Relation to Fosfomycin

Code List

Any relation to intake of Arctuvan (Bearberry preparation)

CL Item

(gesichert)

CL Item

(wahrscheinlich)

CL Item

(möglich)

CL Item

(unwahrscheinlich)

CL Item

(ausgeschlossen)

CL Item

(nicht abschätzbar)

Date of Adverse Event

Item

Date of Adverse Event

date

C2985916 (UMLS CUI [1])

Investigator's Signature

Item

Signature

text

C2346576 (UMLS CUI [1])

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Trefwoorden

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DOI

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Model Commentaren :

Itemgroep Commentaren voor :

Item Commentaren voor :

Questionnaire Day 28 REGATTA NCT03151603

Questionnaire Day 28 REGATTA NCT03151603

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