Patient Identification
Item
Please give Patient ID composed of Study site Nr and Patient Nr
integer
C1269815 (UMLS CUI [1])
Blood pressure
Item
Blood pressure measurement
text
C0005823 (UMLS CUI [1])
Heart rate
Item
Heart rate count
integer
C0018810 (UMLS CUI [1])
Body Height
Item
Body Height
integer
C0005890 (UMLS CUI [1])
Body Weight
Item
Body Weight
float
C0005910 (UMLS CUI [1])
Item
Rhinoscopic evaluation: Edema
text
C0183044 (UMLS CUI [1,1])
C0178628 (UMLS CUI [1,2])
Code List
Rhinoscopic evaluation: Edema
Item
Rhinoscopic evaluation: Secretion
text
C0183044 (UMLS CUI [1,1])
C0178628 (UMLS CUI [1,2])
Code List
Rhinoscopic evaluation: Secretion
Item
Rhinoscopic evaluation: Redness
text
C0183044 (UMLS CUI [1,1])
C0178628 (UMLS CUI [1,2])
Code List
Rhinoscopic evaluation: Redness
Concomitant agent
Item
Has concomitant medication been subject to change?
boolean
C2347852 (UMLS CUI [1])
Concomitant Agent
Item
Please specify any changes of therapy since last visit
text
C2347852 (UMLS CUI [1])
Comorbidities
Item
Have comorbidities changed?
boolean
C0009488 (UMLS CUI [1])
Comorbidities
Item
If comorbidities have changed,please specify any change since last visit
text
C0009488 (UMLS CUI [1])
Laboratory results, safety parameter
Item
Please specify measured hemoglobine and units used
text
C1254595 (UMLS CUI [1,1])
C1269689 (UMLS CUI [1,2])
Laboratory results, safety parameter
Item
Please specify measured amount of erythrocytes and units used
text
C1254595 (UMLS CUI [1,1])
C1269689 (UMLS CUI [1,2])
Laboratory results, safety parameter
Item
Please specify measured amount of leucocytes and units used
text
C1254595 (UMLS CUI [1,1])
C1269689 (UMLS CUI [1,2])
Laboratory results, safety parameter
Item
Please specify measured amount of neutrophils and units used
text
C1254595 (UMLS CUI [1,1])
C1269689 (UMLS CUI [1,2])
Laboratory results, safety parameter
Item
Please specify measured amount of eosinophils and units used
text
C1254595 (UMLS CUI [1,1])
C1269689 (UMLS CUI [1,2])
Laboratory results, safety parameter
Item
Please specify measured amount of basophils and units used
text
C1254595 (UMLS CUI [1,1])
C1269689 (UMLS CUI [1,2])
Laboratory results, safety parameter
Item
Please specify measured amount of monocytes and units used
text
C1254595 (UMLS CUI [1,1])
C1269689 (UMLS CUI [1,2])
Laboratory results, safety parameter
Item
Please specify measured amount of lymphocytes and units used
text
C1254595 (UMLS CUI [1,1])
C1269689 (UMLS CUI [1,2])
Laboratory results, safety parameter
Item
Please specify measured hematocrit and units used
text
C1254595 (UMLS CUI [1,1])
C1269689 (UMLS CUI [1,2])
Laboratory results, safety parameter
Item
Please specify measured amount of thrombocytes and units used
text
C1254595 (UMLS CUI [1,1])
C1269689 (UMLS CUI [1,2])
Laboratory results, safety parameter
Item
Please specify measured amount of total bilirubin and units used
text
C1254595 (UMLS CUI [1,1])
C1269689 (UMLS CUI [1,2])
Laboratory results, safety parameter
Item
Please specify the measured SGPT and units used
text
C1254595 (UMLS CUI [1,1])
C1269689 (UMLS CUI [1,2])
Laboratory results, safety parameter
Item
Please specify the measurement of LDH and units used
text
C1254595 (UMLS CUI [1,1])
C1269689 (UMLS CUI [1,2])
Laboratory results, safety parameter
Item
Please specify the measurement of creatinine and units used
text
C1254595 (UMLS CUI [1,1])
C1269689 (UMLS CUI [1,2])
Laboratory results, safety parameter
Item
Please specify the measurement of serum glutamate-oxaloacetate transaminase and units used
text
C1254595 (UMLS CUI [1,1])
C1269689 (UMLS CUI [1,2])
Laboratory results, safety parameter
Item
Please specify the measurement of CRP and units used
text
C1254595 (UMLS CUI [1,1])
C1269689 (UMLS CUI [1,2])
Diagnosis
Item
Diagnosis based on latest laboratory findings and or current physical examination (please note also as AE)
text
C0011900 (UMLS CUI [1])
Treatment
Item
Please specify further treatment of your patient
text
C0087111 (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?
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
Item
Adverse Event Outcome
text
C1705586 (UMLS CUI [1])
Code List
Adverse Event Outcome
CL Item
resolved with sequelae (4)
CL Item
increased symptoms (5)
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)
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
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 [1,1])
C0041755 (UMLS CUI [1,2])
Code List
Is the AE related to the trial substance?
CL Item
undecided/incomplete (1)
CL Item
without context to trial substance (3)
Date
Item
Date of completion of this form
date
C0011008 (UMLS CUI [1])
Signature
Item
Signature
text
C1519316 (UMLS CUI [1])