ID

13150

Beschrijving

Prospective,multicentric,double blind and placebo-controlled Phase III clinical trial to determine efficacy and tolerability of subcutaneous hyposensitization with CLUSTOID in patients with allergic rhinoconjunctivits caused by grass or rye pollen. EudraCT-Nr. 2008-000513-29 Study-code:CLU-2008-001 Sponsor: ROXALL Medizin GmbH Carl-Petersen-Straße 4 20535 Hamburg Phone:040-8972520 Fax:040-89725223 Project coordinator: Dr.Jenny Uhlig ROXALL Medizin GmbH Head of clinical investigation: Prof.Dr.med.Ludger Klimek An den Quellen 10 65183 Wiesbaden Phone:0611-8904381 Fax:0611-3082360 Monitoring,data management and statistical evaluation: IMSIE- Institut for medical statistics,computer sciences and epidemiology University hospital Cologne Lindenburger Allee 42 50931 Cologne Phone:0221-4783456 Fax:0221-4783465

Trefwoorden

  1. 19-01-16 19-01-16 -
  2. 20-01-16 20-01-16 -
Geüploaded op

20 januari 2016

DOI

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Licentie

Creative Commons BY-NC 3.0

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Efficacy and tolerability of subcutaneous hyposensitization with CLUSTOID in Patients with allergic rhinoconjunctivitis 1.1

Case report form Visit1 part 2

Medical History and documentation of first Dose of trial substance
Beschrijving

Medical History and documentation of first Dose of trial substance

Please give Patient ID composed of Study site Nr and Patient Nr
Beschrijving

Patient Identification

Datatype

integer

Alias
UMLS CUI [1]
C1269815
Has a skin prick test been performed?
Beschrijving

Washout of: Antihistamine-3days local steroids-3days oral steroids up to 14 days-3 days oral steroids longer than 14 days-30days

Datatype

text

Alias
UMLS CUI [1]
C0430561
Date Skin prick test was performed
Beschrijving

Date of Skin prick test

Datatype

date

Alias
UMLS CUI [1]
C0011008
UMLS CUI [2]
C0430561
Reaction to grass:please give the diameter of the resulting rash
Beschrijving

If the resulting rash to grass pollen exposure is smaller than 3mm in diameter it will result in exclusion from trial

Datatype

float

Alias
UMLS CUI [1]
C0430561
Reaction to rye: diameter of rash
Beschrijving

skin prick test

Datatype

float

Alias
UMLS CUI [1]
C0430561
Reaction to birch:diameter of rash
Beschrijving

skin prick test

Datatype

float

Alias
UMLS CUI [1]
C0430561
Reaction to artemisia:diameter of rash
Beschrijving

Skin prick test

Datatype

float

Alias
UMLS CUI [1]
C0430561
Reaction to dust mite:diameter of rash
Beschrijving

Skin prick test

Datatype

float

Alias
UMLS CUI [1]
C0430561
Reaction to cat hair:diameter of rash
Beschrijving

Skin prick test

Datatype

float

Alias
UMLS CUI [1]
C0430561
Reaction to dog hair:diameter of rash
Beschrijving

Skin prick test

Datatype

float

Alias
UMLS CUI [1]
C0430561
Reaction to mold:diameter of rash
Beschrijving

Skin prick test

Datatype

float

Alias
UMLS CUI [1]
C0430561
Reaction to histamin-hydrochloride:diameter of rash
Beschrijving

positive control solution

Datatype

float

Alias
UMLS CUI [1]
C0430561
Reaction to phenolic glycerine-saline solution
Beschrijving

Skin prick test

Datatype

float

Alias
UMLS CUI [1]
C0430561
Please give FVC spirometry result
Beschrijving

Spirometry

Datatype

float

Maateenheden
  • liter
Alias
UMLS CUI [1]
C0037981
liter
Please give FEV1 result of spirometry
Beschrijving

If FEV1 is below 70% of expected normal range it will result in exclusion from trial.

Datatype

float

Maateenheden
  • liter
Alias
UMLS CUI [1]
C0037981
liter
Please give FEV1/FVC spirometry results
Beschrijving

Spirometry

Datatype

integer

Maateenheden
  • %
Alias
UMLS CUI [1]
C0037981
%
Peak expiratory flow measurement 1
Beschrijving

Please take three measurements in a row. The best one will be referred to during all following visits

Datatype

float

Maateenheden
  • liter
Alias
UMLS CUI [1]
C0521299
liter
Peak expiratory flow measurement 2
Beschrijving

Peak expiratory flow measurement

Datatype

float

Maateenheden
  • liter
Alias
UMLS CUI [1]
C0521299
liter
Peak expiratory flow measurement 3
Beschrijving

Peak expiratory flow measurement

Datatype

float

Maateenheden
  • liter
Alias
UMLS CUI [1]
C0521299
liter
Peak expiratory flow measurement: optimum at Visit 1
Beschrijving

Peak expiratory flow measurement

Datatype

float

Maateenheden
  • liter
Alias
UMLS CUI [1]
C0521299
liter
Baseline value of nasal irritation
Beschrijving

Nasal provocation test

Datatype

text

Alias
UMLS CUI [1]
C0027431
blank value of nasal irritation
Beschrijving

Nasal provocation test

Datatype

text

Alias
UMLS CUI [1]
C0027431
First provocation value of nasal irritation
Beschrijving

Nasal provocation test

Datatype

text

Alias
UMLS CUI [1]
C0027431
second provocation value of nasal irritation
Beschrijving

Nasal provocation test

Datatype

text

Alias
UMLS CUI [1]
C0027431
Baseline value of nasal secretion provocation
Beschrijving

Nasal provocation test

Datatype

text

Alias
UMLS CUI [1]
C0027431
Blank value of nasal secretion provocation
Beschrijving

Nasal provocation test

Datatype

text

Alias
UMLS CUI [1]
C0027431
First provocation value of nasal secretion
Beschrijving

Nasal provocation test

Datatype

text

Alias
UMLS CUI [1]
C0027431
Second provocation value of nasal secretion
Beschrijving

Nasal provocation test

Datatype

text

Alias
UMLS CUI [1]
C0027431
Baseline value of remote symptom provocation
Beschrijving

Nasal provocation test

Datatype

text

Alias
UMLS CUI [1]
C0027431
Blank value of remote symptom provocation
Beschrijving

Nasal provocation test

Datatype

text

Alias
UMLS CUI [1]
C0027431
First provocation value of remote symptoms
Beschrijving

Nasal provocation test

Datatype

text

Alias
UMLS CUI [1]
C0027431
second provocation value of remote symptoms
Beschrijving

Nasal provocation test

Datatype

text

Alias
UMLS CUI [1]
C0027431
Sum of nasal provocation test symptom scores: baseline value
Beschrijving

Nasal provocation test

Datatype

integer

Alias
UMLS CUI [1]
C0027431
Sum of nasal provocation test symptom scores: blank value
Beschrijving

Nasal provocation test

Datatype

integer

Alias
UMLS CUI [1]
C0027431
Sum of nasal provocation test symptom scores:first provocation value
Beschrijving

Nasal provocation test

Datatype

integer

Alias
UMLS CUI [1]
C0027431
Sum of nasal provocation test symptom scores:second provocation value
Beschrijving

Nasal provocation test

Datatype

integer

Alias
UMLS CUI [1]
C0027431
Flow volume in cm3/sec baseline value
Beschrijving

Rhinomanometry

Datatype

float

Maateenheden
  • cm3
Alias
UMLS CUI [1]
C0430615
cm3
Flow volume in cm3/sec blank value
Beschrijving

Rhinomanometry

Datatype

float

Maateenheden
  • cm3
Alias
UMLS CUI [1]
C0430615
cm3
Flow volume in cm3/sec first provocation value
Beschrijving

Rhinomanometry

Datatype

float

Maateenheden
  • cm3
Alias
UMLS CUI [1]
C0430615
cm3
Flow volume in cm3/sec second provocation value
Beschrijving

Rhinomanometry

Datatype

float

Maateenheden
  • cm3
Alias
UMLS CUI [1]
C0430615
cm3
Percentage of flow reduction:blank value
Beschrijving

Flow volume reduction >20%=termination of provocation test due to unspecified reaction.

Datatype

integer

Maateenheden
  • %
Alias
UMLS CUI [1]
C0430615
%
Percentage of flow reduction:first provocation value
Beschrijving

Flow volume reduction >40% or symptom score>3 or flow volume reduction >20% plus additional symptom score >2=termination of provocation test Otherwise record second provocation value

Datatype

integer

Maateenheden
  • %
Alias
UMLS CUI [1]
C0430615
%
Percentage of flow reduction:second provocation value
Beschrijving

Flow volume reduction >40% or symptom score >3 or flow volume reduction >20% and aditional symptom score >2 = termination of provocation tests anyway

Datatype

integer

Maateenheden
  • %
Alias
UMLS CUI [1]
C0430615
%
Rhinoscopic evaluation after provocation tests:Edema
Beschrijving

Rhinoscopic evaluation

Datatype

text

Alias
UMLS CUI [1]
C0183044
UMLS CUI [2]
C0178628
Rhinoscopic evaluation after provocation test: secretion
Beschrijving

Rhinoscopic evaluation

Datatype

text

Alias
UMLS CUI [1]
C0183044
UMLS CUI [2]
C0178628
Rhinoscopic evaluation after provocation tests:redness
Beschrijving

Rhinoscopic evaluation

Datatype

text

Alias
UMLS CUI [1]
C0183044
UMLS CUI [2]
C0178628
radioallergosorbent test categories for timothy grass
Beschrijving

Identify RAST-categories [kU/L] for each allergen and note below corresponding category

Datatype

text

Alias
UMLS CUI [1]
C0204726
UMLS CUI [2]
C0443736
Please specify RAST-Category [kU/L] for Timothy grass
Beschrijving

radioallergosorbent test timothy grass

Datatype

float

Maateenheden
  • kU/L
Alias
UMLS CUI [1]
C0799220
kU/L
Radioallergosorbent test categories for rye
Beschrijving

Verification of specific IgE

Datatype

text

Alias
UMLS CUI [1]
C0204726
UMLS CUI [2]
C0443736
Please specify RAST-Category [kU/L] for rye pollen
Beschrijving

Radioallergosorbent test categories for rye

Datatype

float

Maateenheden
  • kU/L
Alias
UMLS CUI [1]
C1271227
kU/L
Total IgE [kU/L]
Beschrijving

Total IgE

Datatype

float

Maateenheden
  • kU/L
Alias
UMLS CUI [1]
C0797024
kU/L
Verification of specific IgG4 RAST cetagories: timothy grass
Beschrijving

Verification of specific IgG4

Datatype

text

Alias
UMLS CUI [1]
C0204726
UMLS CUI [2]
C0443736
Please specify RAST-Category [kU/L] for Timothy grass
Beschrijving

Radioallergosorbent test timothy grass

Datatype

float

Maateenheden
  • kU/L
Alias
UMLS CUI [1]
C0942402
kU/L
Radioallergosorbent test categories for rye
Beschrijving

Verification of specific IgG4

Datatype

text

Alias
UMLS CUI [1]
C0204726
UMLS CUI [2]
C0443736
Please specify RAST-Category [kU/L] for rye pollen
Beschrijving

Radioallergosorbent test categories for rye

Datatype

float

Maateenheden
  • kU/L
Alias
UMLS CUI [1]
C1271227
kU/L
Please specify measured hemoglobine and units used
Beschrijving

Laboratory results, safety parameter

Datatype

text

Alias
UMLS CUI [1]
C1254595
UMLS CUI [2]
C1269689
Please specify measured amount of erythrocytes and units used
Beschrijving

Laboratory results, safety parameter

Datatype

text

Alias
UMLS CUI [1]
C1254595
UMLS CUI [2]
C1269689
Please specify measured amount of leucocytes and units used
Beschrijving

Laboratory results, safety parameter

Datatype

text

Alias
UMLS CUI [1]
C1254595
UMLS CUI [2]
C1269689
Please specify measured amount of neutrophils and units used
Beschrijving

Laboratory results, safety parameter

Datatype

text

Alias
UMLS CUI [1]
C1254595
UMLS CUI [2]
C1269689
Please specify measured amount of eosinophils and units used
Beschrijving

Laboratory results, safety parameter

Datatype

text

Alias
UMLS CUI [1]
C1254595
UMLS CUI [2]
C1269689
Please specify measured amount of basophils and units used
Beschrijving

Laboratory results, safety parameter

Datatype

text

Alias
UMLS CUI [1]
C1254595
UMLS CUI [2]
C1269689
Please specify measured amount of monocytes and units used
Beschrijving

Laboratory results, safety parameter

Datatype

text

Alias
UMLS CUI [1]
C1254595
UMLS CUI [2]
C1269689
Please specify measured amount of lymphocytes and units used
Beschrijving

Laboratory results, safety parameter

Datatype

text

Alias
UMLS CUI [1]
C1254595
UMLS CUI [2]
C1269689
Please specify measured hematocrit and units used
Beschrijving

Laboratory results, safety parameter

Datatype

text

Alias
UMLS CUI [1]
C1254595
UMLS CUI [2]
C1269689
Please specify measured amount of thrombocytes and units used
Beschrijving

Laboratory results, safety parameter

Datatype

text

Alias
UMLS CUI [1]
C1254595
UMLS CUI [2]
C1269689
Please specify measured amount of total bilirubin and units used
Beschrijving

Laboratory results, safety parameter

Datatype

text

Alias
UMLS CUI [1]
C1254595
UMLS CUI [2]
C1269689
Please specify the measured SGPT and units used
Beschrijving

Laboratory results, safety parameter

Datatype

text

Alias
UMLS CUI [1]
C1254595
UMLS CUI [2]
C1269689
Please specify the measurement of LDH and units used
Beschrijving

Laboratory results, safety parameter

Datatype

text

Alias
UMLS CUI [1]
C1254595
UMLS CUI [2]
C1269689
Please specify the measurement of creatinine and units used
Beschrijving

Laboratory results, safety parameter

Datatype

text

Alias
UMLS CUI [1]
C1254595
UMLS CUI [2]
C1269689
Please specify the measurement of serum glutamate-oxaloacetate transaminase and units used
Beschrijving

Laboratory results, safety parameter

Datatype

text

Alias
UMLS CUI [1]
C1254595
UMLS CUI [2]
C1269689
Please specify the measurement of CRP and units used
Beschrijving

Laboratory results, safety parameter

Datatype

text

Alias
UMLS CUI [1]
C1254595
UMLS CUI [2]
C1269689
Subcutaneous desensitization
Beschrijving

Subcutaneous desensitization

Dose one of desensitization substance administered?
Beschrijving

Desensitization

Datatype

boolean

Alias
UMLS CUI [1]
C0849706
Please give the hour the first dose was administered
Beschrijving

Desensitization

Datatype

time

Alias
UMLS CUI [1]
C0849706
If the dose has not been administered, please specify the reason why
Beschrijving

Desensitization

Datatype

text

Alias
UMLS CUI [1]
C0849706
Administered Dose of trial substance
Beschrijving

Desensitization

Datatype

text

Alias
UMLS CUI [1]
C0849706
If dose of trial substance has been adjusted, please specify the reason why and how much has actually been administered
Beschrijving

Desensitization

Datatype

text

Maateenheden
  • ml
Alias
UMLS CUI [1]
C0849706
ml
Please specify wich arm has been used for injection
Beschrijving

Desensitization

Datatype

text

Alias
UMLS CUI [1]
C0849706
30 min after injection, has the patient experienced any local, gastrointestinal, systemic or other symptoms
Beschrijving

if no, continue with injections according to protocol,if yes, please explain further below and eventually adjust dose during next visit.

Datatype

boolean

Alias
UMLS CUI [1]
C0849706
Have any of the following symptoms occured?If yes please do not forget to fill in AE report
Beschrijving

Desensitization

Datatype

text

Alias
UMLS CUI [1]
C0849706
Please specify any other symptoms that occured within 30 min after injection
Beschrijving

Desensitization

Datatype

text

Alias
UMLS CUI [1]
C0849706
Have severe local, gastrointestinal or systemic symptoms occured? If yes, the SAE sheet has to be filled in and sent to the sponsor within 24 hours.
Beschrijving

Serious adverse events during desensitization

Datatype

boolean

Alias
UMLS CUI [1]
C0849706
UMLS CUI [2]
C1519255
What measures have been taken in response to the SAE?
Beschrijving

Action taken in response to SAE

Datatype

text

Alias
UMLS CUI [1]
C1519255
UMLS CUI [2]
C1547656
Has the quality of life form for patients with rhinoconjunctivits been filled in be the patient?
Beschrijving

Quality of life form

Datatype

boolean

Alias
UMLS CUI [1]
C0518214
Has the second dose of desensitization been administered?
Beschrijving

Second desensitization

Datatype

boolean

Alias
UMLS CUI [1]
C0849706
Please give the time, the second dose has been administered
Beschrijving

Second desensitization

Datatype

time

Alias
UMLS CUI [1]
C0849706
If the second dose has not been administered, please specify the reason why
Beschrijving

Second desensitization

Datatype

text

Alias
UMLS CUI [1]
C0849706
How much of the trial substance has been titrated?
Beschrijving

Second desensitization

Datatype

text

Maateenheden
  • ml
Alias
UMLS CUI [1]
C0849706
If the dose of trial substance has been adjusted, please specify the reason why and how much has actually been administered
Beschrijving

Second desensitization

Datatype

text

Alias
UMLS CUI [1]
C0849706
Please specify which arm has been used for injection, please don´t use the same arm as during the first round of desensitization
Beschrijving

Second desensitization

Datatype

text

Alias
UMLS CUI [1]
C0849706
30 min after injection, has the patient experienced any local, gastrointestinal, systemic or other symptoms
Beschrijving

if no, continue with injections according to protocol,if yes, please explain further below and eventually adjust dose during next visit.

Datatype

boolean

Alias
UMLS CUI [1]
C0849706
Have any of the following symptoms occured?If yes please do not forget to fill in AE report
Beschrijving

Seond desensitization

Datatype

text

Alias
UMLS CUI [1]
C0849706
Please specify any other symptoms that occured within 30 min after injection of second desensitization
Beschrijving

Second desensitization

Datatype

text

Alias
UMLS CUI [1]
C0849706
Have severe local, gastrointestinal or systemic symptoms occured during second desensitization? If yes, the SAE sheet has to be filled in and sent to the sponsor within 24 hours.
Beschrijving

Serious adverse events during second desensitization

Datatype

boolean

Alias
UMLS CUI [1]
C0849706
UMLS CUI [2]
C1519255
What measures have been taken in response to the SAE?
Beschrijving

Actions taken in response to the SAE

Datatype

text

Alias
UMLS CUI [1]
C1519255
UMLS CUI [2]
C1547656
Adverse Events
Beschrijving

Adverse Events

Did any Adverse Events occur?
Beschrijving

Adverse Events

Datatype

boolean

Alias
UMLS CUI [1]
C0877248
Have these been serious adverse events?
Beschrijving

In case of SAE please fill in the SAE-form at the end of this CRF asap (24h) and send via FAX to Roxall Medical GmbH (040/89725223)

Datatype

boolean

Alias
UMLS CUI [1]
C1519255
Please describe the AE
Beschrijving

Adverse Event

Datatype

text

Alias
UMLS CUI [1]
C0877248
Adverse Event Start Date
Beschrijving

Adverse Event Start Date

Datatype

date

Alias
UMLS CUI [1]
C2697888
Adverse Event End Date
Beschrijving

Adverse Event End Date

Datatype

date

Alias
UMLS CUI [1]
C2697886
How often did the event occur?
Beschrijving

Adverse event occurrence

Datatype

text

Alias
UMLS CUI [1]
C2697887
Please give your opinion to the severity of the AE
Beschrijving

Adverse event severity

Datatype

text

Alias
UMLS CUI [1]
C1710066
Adverse Event Outcome
Beschrijving

Adverse Event Outcome

Datatype

text

Alias
UMLS CUI [1]
C1705586
What actions have been taken regarding the trial substance?
Beschrijving

Adverse Event actions taken

Datatype

text

Alias
UMLS CUI [1]
C2826626
What other actions have been taken in response to the AE?
Beschrijving

Adverse event actions taken

Datatype

text

Alias
UMLS CUI [1]
C2826719
Is the AE related to the trial substance?
Beschrijving

Adverse event context to trial substance

Datatype

text

Alias
UMLS CUI [1]
C2983596
UMLS CUI [2]
C0041755
Please agree to a date for follow up within next month
Beschrijving

Follow up

Datatype

date

Alias
UMLS CUI [1]
C1522577
Date of completion of this form
Beschrijving

Date

Datatype

date

Alias
UMLS CUI [1]
C0011008
Signature
Beschrijving

Signature

Datatype

text

Alias
UMLS CUI [1]
C1519316

Similar models

Case report form Visit1 part 2

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Medical History and documentation of first Dose of trial substance
Patient Identification
Item
Please give Patient ID composed of Study site Nr and Patient Nr
integer
C1269815 (UMLS CUI [1])
Item
Has a skin prick test been performed?
text
C0430561 (UMLS CUI [1])
Code List
Has a skin prick test been performed?
CL Item
yes (1)
CL Item
no (2)
CL Item
waiting for washout of Antihistamine or Steroids (3)
Date of Skin prick test
Item
Date Skin prick test was performed
date
C0011008 (UMLS CUI [1])
C0430561 (UMLS CUI [2])
skin prick test
Item
Reaction to grass:please give the diameter of the resulting rash
float
C0430561 (UMLS CUI [1])
skin prick test
Item
Reaction to rye: diameter of rash
float
C0430561 (UMLS CUI [1])
skin prick test
Item
Reaction to birch:diameter of rash
float
C0430561 (UMLS CUI [1])
Skin prick test
Item
Reaction to artemisia:diameter of rash
float
C0430561 (UMLS CUI [1])
Skin prick test
Item
Reaction to dust mite:diameter of rash
float
C0430561 (UMLS CUI [1])
Skin prick test
Item
Reaction to cat hair:diameter of rash
float
C0430561 (UMLS CUI [1])
Skin prick test
Item
Reaction to dog hair:diameter of rash
float
C0430561 (UMLS CUI [1])
Skin prick test
Item
Reaction to mold:diameter of rash
float
C0430561 (UMLS CUI [1])
Skin prick test
Item
Reaction to histamin-hydrochloride:diameter of rash
float
C0430561 (UMLS CUI [1])
Skin prick test
Item
Reaction to phenolic glycerine-saline solution
float
C0430561 (UMLS CUI [1])
Spirometry
Item
Please give FVC spirometry result
float
C0037981 (UMLS CUI [1])
Spirometry
Item
Please give FEV1 result of spirometry
float
C0037981 (UMLS CUI [1])
Spirometry
Item
Please give FEV1/FVC spirometry results
integer
C0037981 (UMLS CUI [1])
Peak expiratory flow measurement
Item
Peak expiratory flow measurement 1
float
C0521299 (UMLS CUI [1])
Peak expiratory flow measurement
Item
Peak expiratory flow measurement 2
float
C0521299 (UMLS CUI [1])
Peak expiratory flow measurement
Item
Peak expiratory flow measurement 3
float
C0521299 (UMLS CUI [1])
Peak expiratory flow measurement
Item
Peak expiratory flow measurement: optimum at Visit 1
float
C0521299 (UMLS CUI [1])
Item
Baseline value of nasal irritation
text
C0027431 (UMLS CUI [1])
Code List
Baseline value of nasal irritation
CL Item
0 sneezing 0-2 times (0)
CL Item
1 sneezing 3-5 times (1)
CL Item
2 >5 times (2)
Item
blank value of nasal irritation
text
C0027431 (UMLS CUI [1])
Code List
blank value of nasal irritation
CL Item
0 sneezing 0-2 times (0)
CL Item
1 sneezing 3-5 times (1)
CL Item
2 sneezing >5 times (2)
Item
First provocation value of nasal irritation
text
C0027431 (UMLS CUI [1])
Code List
First provocation value of nasal irritation
CL Item
0 sneezing 0-2 times (0)
CL Item
1 sneezing 3-5 times (1)
CL Item
2 sneezing >5 times (2)
Item
second provocation value of nasal irritation
text
C0027431 (UMLS CUI [1])
Code List
second provocation value of nasal irritation
CL Item
0 sneezing 0-2 times (0)
CL Item
1 sneezing 3-5 times (1)
CL Item
2 sneezing >5 times (2)
Item
Baseline value of nasal secretion provocation
text
C0027431 (UMLS CUI [1])
Code List
Baseline value of nasal secretion provocation
CL Item
0 no secretion (0)
CL Item
1 little secretion (1)
CL Item
2 heavy secretion (2)
Item
Blank value of nasal secretion provocation
text
C0027431 (UMLS CUI [1])
Code List
Blank value of nasal secretion provocation
CL Item
0 no secretion (0)
CL Item
1 little secretion (1)
CL Item
2 heavy secretion (2)
Item
First provocation value of nasal secretion
text
C0027431 (UMLS CUI [1])
Code List
First provocation value of nasal secretion
CL Item
0 no secretion (0)
CL Item
1 little secretion (1)
CL Item
2 heavy secretion (2)
Item
Second provocation value of nasal secretion
text
C0027431 (UMLS CUI [1])
Code List
Second provocation value of nasal secretion
CL Item
0 no secretion (0)
CL Item
1 little secretion (1)
CL Item
2 heavy secretion (2)
Item
Baseline value of remote symptom provocation
text
C0027431 (UMLS CUI [1])
Code List
Baseline value of remote symptom provocation
CL Item
0 none (0)
CL Item
1 lacrimation and/or itching of palate/ears (1)
CL Item
2 conjunctivitis and/or urticaria and/or coughing and/or shortness of breath (2)
Item
Blank value of remote symptom provocation
text
C0027431 (UMLS CUI [1])
Code List
Blank value of remote symptom provocation
CL Item
0 none (0)
CL Item
1 lacrimation and/or itching of palate/ears (1)
CL Item
2 conjunctivitis and/or urticaria and/or coughing and/or shortness of breath (2)
Item
First provocation value of remote symptoms
text
C0027431 (UMLS CUI [1])
Code List
First provocation value of remote symptoms
CL Item
0 none  (0)
CL Item
1 lacrimation and/or itching of palate/ears  (1)
CL Item
2 conjunctivitis and/or urticaria and/or coughing and/or shortness of breath (2)
Item
second provocation value of remote symptoms
text
C0027431 (UMLS CUI [1])
Code List
second provocation value of remote symptoms
CL Item
0 none  (0)
CL Item
1 lacrimation and/or itching of palate/ears  (1)
CL Item
2 conjunctivitis and/or urticaria and/or coughing and/or shortness of breath (2)
Nasal provocation test
Item
Sum of nasal provocation test symptom scores: baseline value
integer
C0027431 (UMLS CUI [1])
Nasal provocation test
Item
Sum of nasal provocation test symptom scores: blank value
integer
C0027431 (UMLS CUI [1])
Nasal provocation test
Item
Sum of nasal provocation test symptom scores:first provocation value
integer
C0027431 (UMLS CUI [1])
Nasal provocation test
Item
Sum of nasal provocation test symptom scores:second provocation value
integer
C0027431 (UMLS CUI [1])
Rhinomanometry
Item
Flow volume in cm3/sec baseline value
float
C0430615 (UMLS CUI [1])
Rhinomanometry
Item
Flow volume in cm3/sec blank value
float
C0430615 (UMLS CUI [1])
Rhinomanometry
Item
Flow volume in cm3/sec first provocation value
float
C0430615 (UMLS CUI [1])
Rhinomanometry
Item
Flow volume in cm3/sec second provocation value
float
C0430615 (UMLS CUI [1])
Rhinomanometry
Item
Percentage of flow reduction:blank value
integer
C0430615 (UMLS CUI [1])
Rhinomanometry
Item
Percentage of flow reduction:first provocation value
integer
C0430615 (UMLS CUI [1])
Rhinomanometry
Item
Percentage of flow reduction:second provocation value
integer
C0430615 (UMLS CUI [1])
Item
Rhinoscopic evaluation after provocation tests:Edema
text
C0183044 (UMLS CUI [1])
C0178628 (UMLS CUI [2])
Code List
Rhinoscopic evaluation after provocation tests:Edema
CL Item
none (0)
CL Item
little (1)
CL Item
severe (2)
Item
Rhinoscopic evaluation after provocation test: secretion
text
C0183044 (UMLS CUI [1])
C0178628 (UMLS CUI [2])
Code List
Rhinoscopic evaluation after provocation test: secretion
CL Item
none (0)
CL Item
clear fluid (1)
CL Item
thick mucous (2)
Item
Rhinoscopic evaluation after provocation tests:redness
text
C0183044 (UMLS CUI [1])
C0178628 (UMLS CUI [2])
Code List
Rhinoscopic evaluation after provocation tests:redness
CL Item
none (0)
CL Item
little (1)
CL Item
severe (2)
Item
radioallergosorbent test categories for timothy grass
text
C0204726 (UMLS CUI [1])
C0443736 (UMLS CUI [2])
Code List
radioallergosorbent test categories for timothy grass
CL Item
<0,35 (0)
CL Item
0,35-069 (I)
CL Item
0,70-3,49 (II)
CL Item
3,50-17,49 (III)
CL Item
17,5-49,99 (IV)
CL Item
50-100 (V)
CL Item
>100 (VI)
radioallergosorbent test timothy grass
Item
Please specify RAST-Category [kU/L] for Timothy grass
float
C0799220 (UMLS CUI [1])
Item
Radioallergosorbent test categories for rye
text
C0204726 (UMLS CUI [1])
C0443736 (UMLS CUI [2])
Code List
Radioallergosorbent test categories for rye
CL Item
<0,35 I= 0,35-069 II= 0,70-3,49 III= 3,50-17,49 IV= 17,5-49,99 V= 50-100 VI= >100 (0)
Radioallergosorbent test categories for rye
Item
Please specify RAST-Category [kU/L] for rye pollen
float
C1271227 (UMLS CUI [1])
Total IgE
Item
Total IgE [kU/L]
float
C0797024 (UMLS CUI [1])
Item
Verification of specific IgG4 RAST cetagories: timothy grass
text
C0204726 (UMLS CUI [1])
C0443736 (UMLS CUI [2])
Code List
Verification of specific IgG4 RAST cetagories: timothy grass
CL Item
<0,35 I= 0,35-069 II= 0,70-3,49 III= 3,50-17,49 IV= 17,5-49,99 V= 50-100 VI= >100 (0)
Radioallergosorbent test timothy grass
Item
Please specify RAST-Category [kU/L] for Timothy grass
float
C0942402 (UMLS CUI [1])
Item
Radioallergosorbent test categories for rye
text
C0204726 (UMLS CUI [1])
C0443736 (UMLS CUI [2])
Code List
Radioallergosorbent test categories for rye
CL Item
<0,35 I= 0,35-069 II= 0,70-3,49 III= 3,50-17,49 IV= 17,5-49,99 V= 50-100 VI= >100 (0)
Radioallergosorbent test categories for rye
Item
Please specify RAST-Category [kU/L] for rye pollen
float
C1271227 (UMLS CUI [1])
Laboratory results, safety parameter
Item
Please specify measured hemoglobine and units used
text
C1254595 (UMLS CUI [1])
C1269689 (UMLS CUI [2])
Laboratory results, safety parameter
Item
Please specify measured amount of erythrocytes and units used
text
C1254595 (UMLS CUI [1])
C1269689 (UMLS CUI [2])
Laboratory results, safety parameter
Item
Please specify measured amount of leucocytes and units used
text
C1254595 (UMLS CUI [1])
C1269689 (UMLS CUI [2])
Laboratory results, safety parameter
Item
Please specify measured amount of neutrophils and units used
text
C1254595 (UMLS CUI [1])
C1269689 (UMLS CUI [2])
Laboratory results, safety parameter
Item
Please specify measured amount of eosinophils and units used
text
C1254595 (UMLS CUI [1])
C1269689 (UMLS CUI [2])
Laboratory results, safety parameter
Item
Please specify measured amount of basophils and units used
text
C1254595 (UMLS CUI [1])
C1269689 (UMLS CUI [2])
Laboratory results, safety parameter
Item
Please specify measured amount of monocytes and units used
text
C1254595 (UMLS CUI [1])
C1269689 (UMLS CUI [2])
Laboratory results, safety parameter
Item
Please specify measured amount of lymphocytes and units used
text
C1254595 (UMLS CUI [1])
C1269689 (UMLS CUI [2])
Laboratory results, safety parameter
Item
Please specify measured hematocrit and units used
text
C1254595 (UMLS CUI [1])
C1269689 (UMLS CUI [2])
Laboratory results, safety parameter
Item
Please specify measured amount of thrombocytes and units used
text
C1254595 (UMLS CUI [1])
C1269689 (UMLS CUI [2])
Laboratory results, safety parameter
Item
Please specify measured amount of total bilirubin and units used
text
C1254595 (UMLS CUI [1])
C1269689 (UMLS CUI [2])
Laboratory results, safety parameter
Item
Please specify the measured SGPT and units used
text
C1254595 (UMLS CUI [1])
C1269689 (UMLS CUI [2])
Laboratory results, safety parameter
Item
Please specify the measurement of LDH and units used
text
C1254595 (UMLS CUI [1])
C1269689 (UMLS CUI [2])
Laboratory results, safety parameter
Item
Please specify the measurement of creatinine and units used
text
C1254595 (UMLS CUI [1])
C1269689 (UMLS CUI [2])
Laboratory results, safety parameter
Item
Please specify the measurement of serum glutamate-oxaloacetate transaminase and units used
text
C1254595 (UMLS CUI [1])
C1269689 (UMLS CUI [2])
Laboratory results, safety parameter
Item
Please specify the measurement of CRP and units used
text
C1254595 (UMLS CUI [1])
C1269689 (UMLS CUI [2])
Item Group
Subcutaneous desensitization
Desensitization
Item
Dose one of desensitization substance administered?
boolean
C0849706 (UMLS CUI [1])
Desensitization
Item
Please give the hour the first dose was administered
time
C0849706 (UMLS CUI [1])
Desensitization
Item
If the dose has not been administered, please specify the reason why
text
C0849706 (UMLS CUI [1])
Item
Administered Dose of trial substance
text
C0849706 (UMLS CUI [1])
Code List
Administered Dose of trial substance
CL Item
0,1 ml according to protocol (1)
CL Item
adjusted dose (2)
Desensitization
Item
If dose of trial substance has been adjusted, please specify the reason why and how much has actually been administered
text
C0849706 (UMLS CUI [1])
Item
Please specify wich arm has been used for injection
text
C0849706 (UMLS CUI [1])
Code List
Please specify wich arm has been used for injection
CL Item
right arm (1)
CL Item
left arm (2)
Desensitization
Item
30 min after injection, has the patient experienced any local, gastrointestinal, systemic or other symptoms
boolean
C0849706 (UMLS CUI [1])
Item
Have any of the following symptoms occured?If yes please do not forget to fill in AE report
text
C0849706 (UMLS CUI [1])
Code List
Have any of the following symptoms occured?If yes please do not forget to fill in AE report
CL Item
local reaction of the skin:swelling,itching,rash,or burning sensation (1)
CL Item
gastrointestinal symptoms:nausea,vomiting,dyspepsia,flatulence,diarrhea (2)
CL Item
systemic reactions (3)
CL Item
unspecified symptoms like headache, discomfort (3.1)
CL Item
minor systemic symptoms like rhinitis,or minor asthmatic symptoms (3.2)
CL Item
non-life-threatening systemic symptoms like urticaria, angioedema,severe asthmatic symptoms (3.3)
CL Item
severe systemic symptoms like anaphylactic shock [extended documentation as SAE] (3.4)
CL Item
other (4)
Desensitization
Item
Please specify any other symptoms that occured within 30 min after injection
text
C0849706 (UMLS CUI [1])
Serious adverse events during desensitization
Item
Have severe local, gastrointestinal or systemic symptoms occured? If yes, the SAE sheet has to be filled in and sent to the sponsor within 24 hours.
boolean
C0849706 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
Item
What measures have been taken in response to the SAE?
text
C1519255 (UMLS CUI [1])
C1547656 (UMLS CUI [2])
Code List
What measures have been taken in response to the SAE?
CL Item
termination of study -> please fill in study completion form (1)
CL Item
adjustment of dose during next course of desensitization (2)
Quality of life form
Item
Has the quality of life form for patients with rhinoconjunctivits been filled in be the patient?
boolean
C0518214 (UMLS CUI [1])
Second desensitization
Item
Has the second dose of desensitization been administered?
boolean
C0849706 (UMLS CUI [1])
Second desensitization
Item
Please give the time, the second dose has been administered
time
C0849706 (UMLS CUI [1])
Second desensitization
Item
If the second dose has not been administered, please specify the reason why
text
C0849706 (UMLS CUI [1])
Item
How much of the trial substance has been titrated?
text
C0849706 (UMLS CUI [1])
Code List
How much of the trial substance has been titrated?
CL Item
0,2ml (1)
CL Item
adjusted dose (2)
Second desensitization
Item
If the dose of trial substance has been adjusted, please specify the reason why and how much has actually been administered
text
C0849706 (UMLS CUI [1])
Item
Please specify which arm has been used for injection, please don´t use the same arm as during the first round of desensitization
text
C0849706 (UMLS CUI [1])
Code List
Please specify which arm has been used for injection, please don´t use the same arm as during the first round of desensitization
CL Item
right arm (1)
CL Item
left arm (2)
Second desensitization
Item
30 min after injection, has the patient experienced any local, gastrointestinal, systemic or other symptoms
boolean
C0849706 (UMLS CUI [1])
Item
Have any of the following symptoms occured?If yes please do not forget to fill in AE report
text
C0849706 (UMLS CUI [1])
Code List
Have any of the following symptoms occured?If yes please do not forget to fill in AE report
CL Item
local reaction of the skin:swelling,itching,rash,or burning sensation (1)
CL Item
gastrointestinal symptoms:nausea,vomiting,dyspepsia,flatulence,diarrhea (2)
CL Item
systemic reactions (3)
CL Item
unspecified symptoms like headache, discomfort (3.1)
CL Item
minor systemic symptoms like rhinitis,or minor asthmatic symptoms (3.2)
CL Item
non-life-threatening systemic symptoms like urticaria, angioedema,severe asthmatic symptoms (3.3)
CL Item
severe systemic symptoms like anaphylactic shock [extended documentation as SAE] (3.4)
CL Item
other (4)
Second desensitization
Item
Please specify any other symptoms that occured within 30 min after injection of second desensitization
text
C0849706 (UMLS CUI [1])
Serious adverse events during second desensitization
Item
Have severe local, gastrointestinal or systemic symptoms occured during second desensitization? If yes, the SAE sheet has to be filled in and sent to the sponsor within 24 hours.
boolean
C0849706 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
Item
What measures have been taken in response to the SAE?
text
C1519255 (UMLS CUI [1])
C1547656 (UMLS CUI [2])
Code List
What measures have been taken in response to the SAE?
CL Item
termination of study -> please fill in study completion form 2=adjustment of dose during next course of desensitization (1)
Item Group
Adverse Events
Adverse Events
Item
Did any Adverse Events occur?
boolean
C0877248 (UMLS CUI [1])
Have these been serious adverse events?
Item
Have these been serious adverse events?
boolean
C1519255 (UMLS CUI [1])
Adverse Event
Item
Please describe the AE
text
C0877248 (UMLS CUI [1])
Adverse Event Start Date
Item
Adverse Event Start Date
date
C2697888 (UMLS CUI [1])
Adverse Event End Date
Item
Adverse Event End Date
date
C2697886 (UMLS CUI [1])
Item
How often did the event occur?
text
C2697887 (UMLS CUI [1])
Code List
How often did the event occur?
CL Item
once (1)
CL Item
regularly (2)
CL Item
continuing (3)
Item
Please give your opinion to the severity of the AE
text
C1710066 (UMLS CUI [1])
Code List
Please give your opinion to the severity of the AE
CL Item
minor (1)
CL Item
moderate (2)
CL Item
severe (3)
Item
Adverse Event Outcome
text
C1705586 (UMLS CUI [1])
Code List
Adverse Event Outcome
CL Item
Recovered (1)
CL Item
Subsiding (2)
CL Item
Continuing (3)
CL Item
resolved with sequelae (4)
CL Item
increased symptoms (5)
CL Item
fatal (6)
Item
What actions have been taken regarding the trial substance?
text
C2826626 (UMLS CUI [1])
Code List
What actions have been taken regarding the trial substance?
CL Item
not applicable (1)
CL Item
no adjustment in dose (2)
CL Item
adjustment of dose (3)
CL Item
suspension of treatment (4)
CL Item
discontinuation of treatment (5)
CL Item
other (6)
Item
What other actions have been taken in response to the AE?
text
C2826719 (UMLS CUI [1])
Code List
What other actions have been taken in response to the AE?
CL Item
none (1)
CL Item
change of concomitant medication (2)
CL Item
hospitalization/prolonged stay in hospital (3)
CL Item
further therapeutic and diagnostic measures (4)
Item
Is the AE related to the trial substance?
text
C2983596 (UMLS CUI [1])
C0041755 (UMLS CUI [2])
Code List
Is the AE related to the trial substance?
CL Item
undecided/incomplete (1)
CL Item
inconclusive (2)
CL Item
without context to trial substance (3)
CL Item
unlikely (4)
CL Item
possible (5)
CL Item
probable (6)
CL Item
confirmed (7)
Follow up
Item
Please agree to a date for follow up within next month
date
C1522577 (UMLS CUI [1])
Date
Item
Date of completion of this form
date
C0011008 (UMLS CUI [1])
Signature
Item
Signature
text
C1519316 (UMLS CUI [1])

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