Examination
Temperature
integer
Blood pressure
integer
Heart rate
integer
Examination of nose
integer
Anatomical / congenital/ operation induced changes?
integer
If yes, please specify type of Antibiotics
integer
Endoscopy
integer
Endoscopy findings
integer
Urine pregnancy test
integer
Please state final weight
integer
Diary collected?
boolean
Medication
Adverse event
Did an adverse event occur?
integer
Is this a serious adverse event ?
integer
Adverse event form
integer
Rhinosinusitis Disability Index (RSBI)
(RSBI) Rhinosinusitis Disability Index (RSBI)
integer
The following questions refer to the effects of chronic sinusitis on your ability to work and your daily activities. Please check the following boxes: 1. Are you currently employed? If no, please continue with question No. 6. The next questions refer to the last 7 days, today excluded: 2. How many hours of work did you miss in the last 7 days due to problems or discomfort resulting from your chronic sinusitis? 3. How many hours of work did you miss in the last 7 days due to other reasons such as holidays or because of participating at this trial? 4. How many hours did you work in the last 7 days in total? If you insert 0 hours, please skip the next question and continue with question 6. 5. How did the chronic sinusitis affect your performance at work in the last 7 days? Please take into consideration those days when the amount and type of work you could accomplish was reduced. Also consider those days when you accomplished less than you had planned to and you did not work as diligently as usual. If the chronic sinusitis had only a minor effect on your work please mark a low number. Mark a high number if you experienced a more severe impairment: 6. How did the chronic sinusitis affect your regular daily activities that are not work related in the last 7 days? Regular activities refer to house and garden work, shopping, education, sport etc.. Please consider the type and amount of your daily activities you could not do. Also consider those days when you accomplished less than you had planned to. If the chronic sinusitis had only a minor effect on your work please mark a low number. Mark a high number if you experienced a more severe impairment:
integer
Laboratory
Blood test
integer
Urinalysis
integer
Overall assessment of the treatment
Please indicate your impression on the efficacy of the trial medication and adverse events that may have occurred. Please take the severity of the disease into account please also take results of previous treatments into consideration.
integer
Assessment of treatment satisfaction
Please indicate one number to each question. How would you rate your satisfaction with the treatment that you have received for your chronic sinusitis?
integer
Please indicate one number to each question.
boolean
Please indicate one number to each question.
integer
Final report
This form is also to be completed at premature study discontinuation.
integer
End of study date and time
integer
Study terminated by
integer
I hereby confirm, that all data in this report have been checked and that they are accurate and substantially true. Signature and date
integer