Screening Exclusion criteria GOAL Trial B-cell Lymphoma NCT02499003

Admininstrative data
Description

Admininstrative data

Subject ID
Description

Subject ID

Data type

text

Exclusion criteria
Description

Exclusion criteria

1. Lymphoma other than DLBCL, FL IIIB, transfomed indolent NHL
Description

Other lymphoma

Data type

boolean

2. CNS involvement (brain MRI is required only in cases of clinically suspicious involvement)
Description

CNS involvement

Data type

boolean

3. Pregnant or breastfeeding women
Description

Pregnancy

Data type

boolean

4. Severe concomitant disease
Description

e.g. uncontrolled arterial hypertension, heart failure (NYHA III-IV), uncontrolled diabetes mellitus, pulmonary fibrosis, uncontrolled hyperlipoproteinaemia

Data type

boolean

5. Myocardial infarction within the last 6 months
Description

Myocardial infarction within the last 6 months

Data type

boolean

6. Active uncontrolled infections incl. HIV-positivity, active Hepatitis B or C
Description

Active uncontrolled infections

Data type

boolean

7. Vaccination with live vaccine within last 4 weeks
Description

Vaccination

Data type

boolean

8. Mental status precluding patient's compliance
Description

Mental status

Data type

boolean

9. Known CD20 negativity
Description

CD20 negativity

Data type

boolean

10. Diagnosed or treated for a malignancy other than NHL
Description

Except: adequately treated nonmelanoma skin cancer, curatively treated in-situ cancer of the Cervix, DCIS of the breast, or other solid tumors curatively treated with no evidence of disease for >3 years, or prostate cancer with a life expectancy of more than 2 years

Data type

boolean

11. Treatment with any approved anticancer agent within last 2 weeks
Description

Any agents must have been stoppped at least 2 weeks prior to day 1 of GOAL treatment and all treatment-related adverse events must have returned to Grade 1.

Data type

boolean

12. Prior exposition to Obinutuzumab or Pixantrone
Description

exposition to Obinutuzumab or Pixantrone

Data type

boolean

13. History of hypersensitivity to medicinal products with similar chemical structure as the trial medication
Description

hypersensitivity to medicinal products

Data type

boolean

14. Active participation in other interventional clinical trials during the present clinical trial or within the last 2 weeks prior to treatment initiation
Description

Concurrent participation in non-treatment studies is not excluded.

Data type

boolean

15. Medical or psychological conditions that would jeopardize an adequate and orderly completion of the trial.
Description

Medical or psychological conditions

Data type

boolean

Similar models

Screening Exclusion criteria GOAL Trial B-cell Lymphoma NCT02499003

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Admininstrative data
Subject ID
Item
Subject ID
text
Item Group
Exclusion criteria
Other lymphoma
Item
1. Lymphoma other than DLBCL, FL IIIB, transfomed indolent NHL
boolean
CNS involvement
Item
2. CNS involvement (brain MRI is required only in cases of clinically suspicious involvement)
boolean
Pregnancy
Item
3. Pregnant or breastfeeding women
boolean
Severe concomitant disease
Item
4. Severe concomitant disease
boolean
Myocardial infarction within the last 6 months
Item
5. Myocardial infarction within the last 6 months
boolean
Active uncontrolled infections
Item
6. Active uncontrolled infections incl. HIV-positivity, active Hepatitis B or C
boolean
Vaccination
Item
7. Vaccination with live vaccine within last 4 weeks
boolean
Mental status
Item
8. Mental status precluding patient's compliance
boolean
CD20 negativity
Item
9. Known CD20 negativity
boolean
malignancy other than NHL
Item
10. Diagnosed or treated for a malignancy other than NHL
boolean
Treatment with anticancer agent
Item
11. Treatment with any approved anticancer agent within last 2 weeks
boolean
exposition to Obinutuzumab or Pixantrone
Item
12. Prior exposition to Obinutuzumab or Pixantrone
boolean
hypersensitivity to medicinal products
Item
13. History of hypersensitivity to medicinal products with similar chemical structure as the trial medication
boolean
participation in other interventional clinical trials
Item
14. Active participation in other interventional clinical trials during the present clinical trial or within the last 2 weeks prior to treatment initiation
boolean
Medical or psychological conditions
Item
15. Medical or psychological conditions that would jeopardize an adequate and orderly completion of the trial.
boolean