ID

27314

Description

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

Keywords

Versions (1)
  1. 11/7/17 11/7/17 -
Copyright Holder

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

Uploaded on

November 7, 2017

DOI

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License

Creative Commons BY-NC-ND 3.0
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Questionnaire Day 28 REGATTA NCT03151603

German English

Questionnaire Day 28 REGATTA NCT03151603

1 forms  
General Information
Description

General Information

Alias
UMLS CUI-1
C1508263
Filled in (Date):
Description

Visit Date

Data type

date

Previous Urinary Tract Infection
Description

Previous Urinary Tract Infection

Alias
UMLS CUI-1
C0205156
UMLS CUI-2
C0042029
1. Did you have one or more urinary tract infection in the last three weeks?
Description

Previous Urinary Tract Infection

Data type

boolean

Alias
UMLS CUI [1,1]
C0205156
UMLS CUI [1,2]
C0042029
1a. If YES, how many urinary tract or bladder infections did you have in the last three weeks? (Please specify the number:)
Description

Numbers of Previous Urinary Tract Infection

Data type

text

Alias
UMLS CUI [1,1]
C0449788
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0042029
1b. Have you been on sick leave due to an urinary tract infection in the last 4 weeks (since the beginning of the study)?
Description

Urinary Tract Infection: Sick Leave

Data type

boolean

Alias
UMLS CUI [1,1]
C0242807
UMLS CUI [1,2]
C0042029
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:
Description

Urinary Tract Infection: Sick Leave Specification

Data type

float

Measurement units
  • Tage
Alias
UMLS CUI [1,1]
C0242807
UMLS CUI [1,2]
C0042029
UMLS CUI [1,3]
C2348235
Tage
1c. When was your last urinary tract infection (in the last 3 weeks)? Start Date:
Description

Urinary Tract Infection: Start Date

Data type

date

Measurement units
  • tt.mm.jjjj
Alias
UMLS CUI [1,1]
C0042029
UMLS CUI [1,2]
C0808070
tt.mm.jjjj
1c. When was your last urinary tract infection (in the last 3 weeks)? End Date:
Description

Urinary Tract Infection: End Date

Data type

date

Measurement units
  • tt.mm.jjjj
Alias
UMLS CUI [1,1]
C0042029
UMLS CUI [1,2]
C0806020
tt.mm.jjjj
1d. Did you went to your general practitioner or another doctor because of your last urinary tract infection?
Description

Urinary Tract Infection: Office Visit

Data type

boolean

Alias
UMLS CUI [1,1]
C0042029
UMLS CUI [1,2]
C0028900
1d1. If YES, who provided medical care? (several answers are possible)
Description

Urinary Tract Infection: Physicians

Data type

text

Alias
UMLS CUI [1,1]
C0042029
UMLS CUI [1,2]
C0031831
1d2. Had fever (>38°C) occurred in the course of this urinary tract infection?
Description

Urinary Tract Infection: Febrile Infection

Data type

boolean

Alias
UMLS CUI [1,1]
C0042029
UMLS CUI [1,2]
C0948233
Pharmacotherapy - If you have a further urinary tract infection, continue on page 3. If you have further health problems/issues continue on page 4.
Description

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

Alias
UMLS CUI-1
C0013216
2. Have you taken any medication (antibiotics, analgesics, other medication, herbal drugs) for an urinary tract infection in the last 3 weeks?
Description

If YES, please specify everything what you have not noted in patient diary.

Data type

boolean

Alias
UMLS CUI [1]
C0013216
Antibiotics: Drug Name (e.g. Cefuroxim)
Description

Antibiotics

Data type

text

Alias
UMLS CUI [1]
C0003232
Antibiotics: Dosage (e.g. 500 mg)
Description

Antibiotics: Dosage

Data type

text

Alias
UMLS CUI [1,1]
C0003232
UMLS CUI [1,2]
C0178602
Antibiotics: Medication Frequency (e.g. 2x1 tablets)
Description

Antibiotics: Medication Frequency

Data type

text

Alias
UMLS CUI [1,1]
C0003232
UMLS CUI [1,2]
C3476109
Antibiotics: Start Date
Description

Antibiotics: Start Date

Data type

date

Measurement units
  • tt.mm.jjjj
Alias
UMLS CUI [1,1]
C0003232
UMLS CUI [1,2]
C0808070
tt.mm.jjjj
Antibiotics: End Date
Description

Antibiotics: End Date

Data type

date

Measurement units
  • tt.mm.jjjj
Alias
UMLS CUI [1,1]
C0003232
UMLS CUI [1,2]
C0806020
tt.mm.jjjj
Analgesics: Drug Name
Description

Analgesics

Data type

text

Alias
UMLS CUI [1]
C0002771
Analgesics: Dosage (e.g. 500 mg)
Description

Analgesics: Dosage

Data type

text

Alias
UMLS CUI [1,1]
C0002771
UMLS CUI [1,2]
C0178602
Analgesics: Medication Frequency (e.g. 2x1 tablets)
Description

Analgesics: Medication Frequency

Data type

text

Alias
UMLS CUI [1,1]
C0002771
UMLS CUI [1,2]
C3476109
Analgesics: Start Date
Description

Analgesics: Start Date

Data type

date

Measurement units
  • tt.mm.jjjj
Alias
UMLS CUI [1,1]
C0002771
UMLS CUI [1,2]
C0808070
tt.mm.jjjj
Analgesics: End Date
Description

Anagesics: End Date

Data type

date

Measurement units
  • tt.mm.jjjj
Alias
UMLS CUI [1,1]
C0002771
UMLS CUI [1,2]
C0806020
tt.mm.jjjj
Other Medication: Drug Name
Description

Other Medication

Data type

text

Alias
UMLS CUI [1]
C1115771
Other Medication: Dosage (e.g. 500 mg)
Description

Other Medication: Dosage

Data type

text

Alias
UMLS CUI [1,1]
C1115771
UMLS CUI [1,2]
C0178602
Other Medication: Medication Frequency (e.g. 2x1 tablets)
Description

Other Medication: Medication Frequency

Data type

text

Alias
UMLS CUI [1,1]
C1115771
UMLS CUI [1,2]
C3476109
Other Medication: Start Date
Description

Other Medication: Start Date

Data type

date

Measurement units
  • tt.mm.jjjj
Alias
UMLS CUI [1,1]
C1115771
UMLS CUI [1,2]
C0808070
tt.mm.jjjj
Other Medication: End Date
Description

Other Medication: End Date

Data type

date

Measurement units
  • tt.mm.jjjj
Alias
UMLS CUI [1,1]
C1115771
UMLS CUI [1,2]
C0806020
tt.mm.jjjj
Further Urinary Tract Infection
Description

Further Urinary Tract Infection

Alias
UMLS CUI-1
C0042029
UMLS CUI-2
C1517331
3. Did you have a further urinary tract infection in the last three weeks?
Description

Further Urinary Tract Infection

Data type

boolean

Alias
UMLS CUI [1,1]
C0042029
UMLS CUI [1,2]
C1517331
3a. Date of further Urinary Tract Infection?
Description

Date of Further Urinary Tract Infection

Data type

date

Measurement units
  • tt.mm.jjjj
Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0042029
UMLS CUI [1,3]
C1517331
tt.mm.jjjj
3b. Did you went to your general practitioner or another doctor because of further urinary tract infection?
Description

Further Urinary Tract Infection: Office Visit

Data type

boolean

Alias
UMLS CUI [1,1]
C1517331
UMLS CUI [1,2]
C0042029
UMLS CUI [1,3]
C0028900
3b1. If YES, who provided medical care? (several answers are possible)
Description

Further Urinary Tract Infection: Physicians

Data type

text

Alias
UMLS CUI [1,1]
C1517331
UMLS CUI [1,2]
C0042029
UMLS CUI [1,3]
C0031831
3b2. Had fever (>38°C) occurred in the course of this urinary tract infection?
Description

Further Urinary Tract Infection: Febrile Infection

Data type

boolean

Alias
UMLS CUI [1,1]
C1517331
UMLS CUI [1,2]
C0042029
UMLS CUI [1,3]
C0948233
Pharmacotherapy: Further Urinary Tract Infection
Description

Pharmacotherapy: Further Urinary Tract Infection

Alias
UMLS CUI-1
C0013216
UMLS CUI-2
C0042029
UMLS CUI-3
C1517331
4. Have you taken any medication (antibiotics, analgesics, other medication, herbal drugs) for this further urinary tract infection?
Description

If YES, please specify everything what you have not noted in patient diary.

Data type

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C1517331
Antibiotics: Drug Name (e.g. Cefuroxim)
Description

Further Antibiotics

Data type

text

Alias
UMLS CUI [1,1]
C0003232
UMLS CUI [1,2]
C1517331
Antibiotics: Dosage (e.g. 500 mg)
Description

Further Antibiotics: Dosage

Data type

text

Alias
UMLS CUI [1,1]
C0003232
UMLS CUI [1,2]
C1517331
UMLS CUI [1,3]
C0178602
Antibiotics: Medication Frequency (e.g. 2x1 tablets)
Description

Further Antibiotics: Medication Frequency

Data type

text

Alias
UMLS CUI [1,1]
C0003232
UMLS CUI [1,2]
C1517331
UMLS CUI [1,3]
C3476109
Antibiotics: Start Date
Description

Further Antibiotics: Start Date

Data type

date

Measurement units
  • tt.mm.jjjj
Alias
UMLS CUI [1,1]
C0003232
UMLS CUI [1,2]
C1517331
UMLS CUI [1,3]
C0808070
tt.mm.jjjj
Antibiotics: End Date
Description

Further Antibiotics: End Date

Data type

date

Measurement units
  • tt.mm.jjjj
Alias
UMLS CUI [1,1]
C0003232
UMLS CUI [1,2]
C1517331
UMLS CUI [1,3]
C0806020
tt.mm.jjjj
Analgesics: Drug Name
Description

Further Analgesics

Data type

text

Alias
UMLS CUI [1,1]
C0002771
UMLS CUI [1,2]
C1517331
Analgesics: Dosage (e.g. 500 mg)
Description

Further Analgesics: Dosage

Data type

text

Alias
UMLS CUI [1,1]
C0002771
UMLS CUI [1,2]
C1517331
UMLS CUI [1,3]
C0178602
Analgesics: Medication Frequency (e.g. 2x1 tablets)
Description

Further Analgesics: Medication Frequency

Data type

text

Alias
UMLS CUI [1,1]
C0002771
UMLS CUI [1,2]
C1517331
UMLS CUI [1,3]
C3476109
Analgesics: Start Date
Description

Further Analgesics: Start Date

Data type

date

Measurement units
  • tt.mm.jjjj
Alias
UMLS CUI [1,1]
C0002771
UMLS CUI [1,2]
C1517331
UMLS CUI [1,3]
C0808070
tt.mm.jjjj
Analgesics: End Date
Description

Further Anagesics: End Date

Data type

date

Measurement units
  • tt.mm.jjjj
Alias
UMLS CUI [1,1]
C0002771
UMLS CUI [1,2]
C1517331
UMLS CUI [1,3]
C0806020
tt.mm.jjjj
Other Medication: Drug Name
Description

Further Other Medication

Data type

text

Alias
UMLS CUI [1,1]
C1115771
UMLS CUI [1,2]
C1517331
Other Medication: Dosage (e.g. 500 mg)
Description

Further Other Medication: Dosage

Data type

text

Alias
UMLS CUI [1,1]
C1115771
UMLS CUI [1,2]
C1517331
UMLS CUI [1,3]
C0178602
Other Medication: Medication Frequency (e.g. 2x1 tablets)
Description

Further Other Medication: Medication Frequency

Data type

text

Alias
UMLS CUI [1,1]
C1115771
UMLS CUI [1,2]
C1517331
UMLS CUI [1,3]
C3476109
Other Medication: Start Date
Description

Further Other Medication: Start Date

Data type

date

Measurement units
  • tt.mm.jjjj
Alias
UMLS CUI [1,1]
C1115771
UMLS CUI [1,2]
C1517331
UMLS CUI [1,3]
C0808070
tt.mm.jjjj
Other Medication: End Date
Description

Further Other Medication: End Date

Data type

date

Measurement units
  • tt.mm.jjjj
Alias
UMLS CUI [1,1]
C1115771
UMLS CUI [1,2]
C1517331
UMLS CUI [1,3]
C0806020
tt.mm.jjjj
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.
Description

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.

Alias
UMLS CUI-1
C1457887
5. Did you have a further symptoms since study inclusion?
Description

Further Symptoms

Data type

boolean

Alias
UMLS CUI [1]
C1457887
5a. If YES, please specify your symptoms.
Description

Further Symptoms: Specification

Data type

text

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C2348235
5b. When did your symptoms occur? Start Date
Description

Further Symptoms: Start Date

Data type

date

Measurement units
  • tt.mm.jjjj
Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0808070
tt.mm.jjjj
5b. When did your symptoms occur? End Date
Description

Further Symptoms: End Date

Data type

date

Measurement units
  • tt.mm.jjjj
Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0806020
tt.mm.jjjj
5c. How much have you been affected by the described symptoms in your everyday life?
Description

Affected by Further Symptoms

Data type

text

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0392760
5d. Did you went to your general practitioner or another doctor because of the described symptoms?
Description

Further Symptoms: Office Visit

Data type

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0028900
5d1. If YES, who provided medical care? (several answers are possible)
Description

Further Symptoms: Physicians

Data type

text

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0031831
5d2. Specify the treatment. (several answers are possible)
Description

Further Symptoms: Treatment

Data type

text

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0087111
5d2. Specify the treatment. If REFERRAL, please specify.
Description

Further Symptoms: Referral

Data type

text

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0034927
5d2. Specify the treatment. If OTHER, please specify.
Description

Further Symptoms: Treatment Specification

Data type

text

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C2348235
Pharmacotherapy: Further Symptoms - Please note every medication you have taken for this symptom.
Description

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

Alias
UMLS CUI-1
C0013216
UMLS CUI-2
C1457887
Antibiotics: Drug Name (e.g. Cefuroxim)
Description

Antibiotics

Data type

text

Alias
UMLS CUI [1]
C0003232
Antibiotics: Dosage (e.g. 500 mg)
Description

Antibiotics: Dosage

Data type

text

Alias
UMLS CUI [1,1]
C0003232
UMLS CUI [1,2]
C0178602
Antibiotics: Medication Frequency (e.g. 2x1 tablets)
Description

Antibiotics: Medication Frequency

Data type

text

Alias
UMLS CUI [1,1]
C0003232
UMLS CUI [1,2]
C3476109
Antibiotics: Start Date
Description

Antibiotics: Start Date

Data type

date

Measurement units
  • tt.mm.jjjj
Alias
UMLS CUI [1,1]
C0003232
UMLS CUI [1,2]
C0808070
tt.mm.jjjj
Antibiotics: End Date
Description

Antibiotics: End Date

Data type

date

Measurement units
  • tt.mm.jjjj
Alias
UMLS CUI [1,1]
C0003232
UMLS CUI [1,2]
C0806020
tt.mm.jjjj
Analgesics: Drug Name
Description

Analgesics

Data type

text

Alias
UMLS CUI [1]
C0002771
Analgesics: Dosage (e.g. 500 mg)
Description

Analgesics: Dosage

Data type

text

Alias
UMLS CUI [1,1]
C0002771
UMLS CUI [1,2]
C0178602
Analgesics: Medication Frequency (e.g. 2x1 tablets)
Description

Analgesics: Medication Frequency

Data type

text

Alias
UMLS CUI [1,1]
C0002771
UMLS CUI [1,2]
C3476109
Analgesics: Start Date
Description

Analgesics: Start Date

Data type

date

Measurement units
  • tt.mm.jjjj
Alias
UMLS CUI [1,1]
C0002771
UMLS CUI [1,2]
C0808070
tt.mm.jjjj
Analgesics: End Date
Description

Anagesics: End Date

Data type

date

Measurement units
  • tt.mm.jjjj
Alias
UMLS CUI [1,1]
C0002771
UMLS CUI [1,2]
C0806020
tt.mm.jjjj
Other Medication: Drug Name
Description

Other Medication

Data type

text

Alias
UMLS CUI [1]
C1115771
Other Medication: Dosage (e.g. 500 mg)
Description

Other Medication: Dosage

Data type

text

Alias
UMLS CUI [1,1]
C1115771
UMLS CUI [1,2]
C0178602
Other Medication: Medication Frequency (e.g. 2x1 tablets)
Description

Other Medication: Medication Frequency

Data type

text

Alias
UMLS CUI [1,1]
C1115771
UMLS CUI [1,2]
C3476109
Other Medication: Start Date
Description

Other Medication: Start Date

Data type

date

Measurement units
  • tt.mm.jjjj
Alias
UMLS CUI [1,1]
C1115771
UMLS CUI [1,2]
C0808070
tt.mm.jjjj
Other Medication: End Date
Description

Other Medication: End Date

Data type

date

Measurement units
  • tt.mm.jjjj
Alias
UMLS CUI [1,1]
C1115771
UMLS CUI [1,2]
C0806020
tt.mm.jjjj
Study Medication
Description

Study Medication

Alias
UMLS CUI-1
C0304229
Study Medication fully completed?
Description

Study Medication Completed

Data type

boolean

Alias
UMLS CUI [1]
C2826299
Adverse Event
Description

Adverse Event

Alias
UMLS CUI-1
C0877248
Symptoms of Adverse Event
Description

Adverse Event Symptom

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1457887
Diagnosis of Adverse Event
Description

Adverse Event Diagnosis

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0011900
ICD-10-Code
Description

Adverse Event ICD-10-Code

Data type

text

Alias
UMLS CUI [1,1]
C2598420
UMLS CUI [1,2]
C0877248
Start Date
Description

Adverse Event: Start Date

Data type

date

Measurement units
  • tt.mm.jjjj
Alias
UMLS CUI [1]
C2697888
tt.mm.jjjj
End Date
Description

Adverse Event: End Date

Data type

date

Measurement units
  • tt.mm.jjjj
Alias
UMLS CUI [1]
C2697886
tt.mm.jjjj
Ongoing?
Description

Adverse Event: Ongoing

Data type

boolean

Alias
UMLS CUI [1]
C2826663
Is a SAE present?
Description

Serious Adverse Event

Data type

text

Alias
UMLS CUI [1]
C1519255
Outcome of Adverse Event
Description

Adverse Event Outcome

Data type

text

Alias
UMLS CUI [1]
C1705586
Severity of Adverse Event
Description

Severity of Adverse Event

Data type

text

Alias
UMLS CUI [1]
C1710066
Action Taken
Description

Adverse Event Action Taken

Data type

text

Alias
UMLS CUI [1]
C2826626
If Action Taken with Concomitant Medication, specify: Substance
Description

Concomitant Medication: Pharmaceutical Preparations

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0013227
If Action Taken with Concomitant Medication, specify: Daily Dosage
Description

Concomitant Medication: Daily Dosage

Data type

text

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C2347852
Any relation to intake of fosfomycin?
Description

Relation to Fosfomycin

Data type

text

Alias
UMLS CUI [1,1]
C0439849
UMLS CUI [1,2]
C0016610
Any relation to intake of Arctuvan (Bearberry preparation)
Description

Relation to Bearberry preparation

Data type

text

Alias
UMLS CUI [1,1]
C0439849
UMLS CUI [1,2]
C0885849
Date of Adverse Event
Description

Date of Adverse Event

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1]
C2985916
dd-mmm-yyyy
Signature
Description

Investigator's Signature

Data type

text

Alias
UMLS CUI [1]
C2346576
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Similar models

Questionnaire Day 28 REGATTA NCT03151603

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
General Information
C1508263 (UMLS CUI-1)
Visit Date
Item
Filled in (Date):
date
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])
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])
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])
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])
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])
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])
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])
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])
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)
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])
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])
Item Group
Study Medication
C0304229 (UMLS CUI-1)
Study Medication Completed
Item
Study Medication fully completed?
boolean
C2826299 (UMLS CUI [1])
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])
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)
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)
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)
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])
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)
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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