Item
Study part:
text
C0008976 (UMLS CUI [1,1])
C0449719 (UMLS CUI [1,2])
CL Item
Screening (Screening)
CL Item
Day I Pre-dose (Day I Pre-dose)
CL Item
Day 14 + 24H (Day 15) (Day 14 + 24H (Day 15))
Item
1. Blood and lymphatic system disorders
integer
C0851353 (UMLS CUI [1])
Code List
1. Blood and lymphatic system disorders
CL Item
Current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
Past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
No Medical Condition (3)
C1298908 (UMLS CUI-1)
C0012634 (UMLS CUI-2)
(Comment:en)
CL Item
Not Assessed (4)
C3846720 (UMLS CUI-1)
(Comment:en)
Item
2. Cardiac disorders
integer
C0018799 (UMLS CUI [1])
Code List
2. Cardiac disorders
CL Item
Current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
Past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
No Medical Condition (3)
C1298908 (UMLS CUI-1)
C0012634 (UMLS CUI-2)
(Comment:en)
CL Item
Not Assessed (4)
C3846720 (UMLS CUI-1)
(Comment:en)
Item
3. Ear and labyrinth disorders
integer
C0851354 (UMLS CUI [1])
Code List
3. Ear and labyrinth disorders
CL Item
Current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
Past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
No Medical Condition (3)
C1298908 (UMLS CUI-1)
C0012634 (UMLS CUI-2)
(Comment:en)
CL Item
Not Assessed (4)
C3846720 (UMLS CUI-1)
(Comment:en)
Item
4. Endocrine disorders
integer
C0014130 (UMLS CUI [1])
Code List
4. Endocrine disorders
CL Item
Current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
Past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
No Medical Condition (3)
C1298908 (UMLS CUI-1)
C0012634 (UMLS CUI-2)
(Comment:en)
CL Item
Not Assessed (4)
C3846720 (UMLS CUI-1)
(Comment:en)
Item
5. Eye disorders
integer
C0015397 (UMLS CUI [1])
Code List
5. Eye disorders
CL Item
Current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
Past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
No Medical Condition (3)
C1298908 (UMLS CUI-1)
C0012634 (UMLS CUI-2)
(Comment:en)
CL Item
Not Assessed (4)
C3846720 (UMLS CUI-1)
(Comment:en)
Item
6. Gastrointestinal disorders
integer
C0017178 (UMLS CUI [1])
Code List
6. Gastrointestinal disorders
CL Item
Current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
Past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
No Medical Condition (3)
C1298908 (UMLS CUI-1)
C0012634 (UMLS CUI-2)
(Comment:en)
CL Item
Not Assessed (4)
C3846720 (UMLS CUI-1)
(Comment:en)
Item
7. Hepatobiliary disorders
integer
C0267792 (UMLS CUI [1])
Code List
7. Hepatobiliary disorders
CL Item
Current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
Past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
No Medical Condition (3)
C1298908 (UMLS CUI-1)
C0012634 (UMLS CUI-2)
(Comment:en)
CL Item
Not Assessed (4)
C3846720 (UMLS CUI-1)
(Comment:en)
Item
8. Immune system disorders
integer
C1334156 (UMLS CUI [1])
Code List
8. Immune system disorders
CL Item
Current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
Past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
No Medical Condition (3)
C1298908 (UMLS CUI-1)
C0012634 (UMLS CUI-2)
(Comment:en)
CL Item
Not Assessed (4)
C3846720 (UMLS CUI-1)
(Comment:en)
Item
9. Metabolism and nutrition disorders
integer
C0851358 (UMLS CUI [1])
Code List
9. Metabolism and nutrition disorders
CL Item
Current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
Past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
No Medical Condition (3)
C1298908 (UMLS CUI-1)
C0012634 (UMLS CUI-2)
(Comment:en)
CL Item
Not Assessed (4)
C3846720 (UMLS CUI-1)
(Comment:en)
Item
10. Musculoskeletal and connective tissue disorders
integer
C0263660 (UMLS CUI [1])
Code List
10. Musculoskeletal and connective tissue disorders
CL Item
Current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
Past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
No Medical Condition (3)
C1298908 (UMLS CUI-1)
C0012634 (UMLS CUI-2)
(Comment:en)
CL Item
Not Assessed (4)
C3846720 (UMLS CUI-1)
(Comment:en)
Item
11. Neoplasms benign, malignant and unspecified (including cysts and polyps)
integer
C0027651 (UMLS CUI [1])
Code List
11. Neoplasms benign, malignant and unspecified (including cysts and polyps)
CL Item
Current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
Past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
No Medical Condition (3)
C1298908 (UMLS CUI-1)
C0012634 (UMLS CUI-2)
(Comment:en)
CL Item
Not Assessed (4)
C3846720 (UMLS CUI-1)
(Comment:en)
Item
12. Nervous system disorders
integer
C0027765 (UMLS CUI [1])
Code List
12. Nervous system disorders
CL Item
Current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
Past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
No Medical Condition (3)
C1298908 (UMLS CUI-1)
C0012634 (UMLS CUI-2)
(Comment:en)
CL Item
Not Assessed (4)
C3846720 (UMLS CUI-1)
(Comment:en)
Item
13. Psychiatric disorders
integer
C0004936 (UMLS CUI [1])
Code List
13. Psychiatric disorders
CL Item
Current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
Past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
No Medical Condition (3)
C1298908 (UMLS CUI-1)
C0012634 (UMLS CUI-2)
(Comment:en)
CL Item
Not Assessed (4)
C3846720 (UMLS CUI-1)
(Comment:en)
Item
14. Renal and urinary disorders
integer
C0042075 (UMLS CUI [1])
Code List
14. Renal and urinary disorders
CL Item
Current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
Past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
No Medical Condition (3)
C1298908 (UMLS CUI-1)
C0012634 (UMLS CUI-2)
(Comment:en)
CL Item
Not Assessed (4)
C3846720 (UMLS CUI-1)
(Comment:en)
Item
15. Reproductive system and breast disorders
integer
C0851366 (UMLS CUI [1])
Code List
15. Reproductive system and breast disorders
CL Item
Current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
Past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
No Medical Condition (3)
C1298908 (UMLS CUI-1)
C0012634 (UMLS CUI-2)
(Comment:en)
CL Item
Not Assessed (4)
C3846720 (UMLS CUI-1)
(Comment:en)
Item
16. Respiratory, thoracic and mediastinal disorders
integer
C0851355 (UMLS CUI [1])
Code List
16. Respiratory, thoracic and mediastinal disorders
CL Item
Current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
Past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
No Medical Condition (3)
C1298908 (UMLS CUI-1)
C0012634 (UMLS CUI-2)
(Comment:en)
CL Item
Not Assessed (4)
C3846720 (UMLS CUI-1)
(Comment:en)
Item
17. Skin and subcutaneous tissue disorders
integer
C0178301 (UMLS CUI [1])
Code List
17. Skin and subcutaneous tissue disorders
CL Item
Current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
Past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
No Medical Condition (3)
C1298908 (UMLS CUI-1)
C0012634 (UMLS CUI-2)
(Comment:en)
CL Item
Not Assessed (4)
C3846720 (UMLS CUI-1)
(Comment:en)
Item
18. Vascular disorders
integer
C0042373 (UMLS CUI [1])
Code List
18. Vascular disorders
CL Item
Current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
Past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
No Medical Condition (3)
C1298908 (UMLS CUI-1)
C0012634 (UMLS CUI-2)
(Comment:en)
CL Item
Not Assessed (4)
C3846720 (UMLS CUI-1)
(Comment:en)
Item
19. Infections and infestations
integer
C0009450 (UMLS CUI [1,1])
C0851341 (UMLS CUI [1,2])
Code List
19. Infections and infestations
CL Item
Current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
Past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
No Medical Condition (3)
C1298908 (UMLS CUI-1)
C0012634 (UMLS CUI-2)
(Comment:en)
CL Item
Not Assessed (4)
C3846720 (UMLS CUI-1)
(Comment:en)
Item
20. Congenital, familial and genetic disorders
integer
C0851352 (UMLS CUI [1])
Code List
20. Congenital, familial and genetic disorders
CL Item
Current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
Past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
No Medical Condition (3)
C1298908 (UMLS CUI-1)
C0012634 (UMLS CUI-2)
(Comment:en)
CL Item
Not Assessed (4)
C3846720 (UMLS CUI-1)
(Comment:en)
Item
21. General disorder and administration site conditions
integer
C1142435 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
Code List
21. General disorder and administration site conditions
CL Item
Current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
Past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
No Medical Condition (3)
C1298908 (UMLS CUI-1)
C0012634 (UMLS CUI-2)
(Comment:en)
CL Item
Not Assessed (4)
C3846720 (UMLS CUI-1)
(Comment:en)
Item
22. Injury, poisoning and procedural complications
integer
C0947733 (UMLS CUI [1])
Code List
22. Injury, poisoning and procedural complications
CL Item
Current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
Past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
No Medical Condition (3)
C1298908 (UMLS CUI-1)
C0012634 (UMLS CUI-2)
(Comment:en)
CL Item
Not Assessed (4)
C3846720 (UMLS CUI-1)
(Comment:en)
Item
23. Investigations
integer
C0841577 (UMLS CUI [1])
Code List
23. Investigations
CL Item
Current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
Past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
No Medical Condition (3)
C1298908 (UMLS CUI-1)
C0012634 (UMLS CUI-2)
(Comment:en)
CL Item
Not Assessed (4)
C3846720 (UMLS CUI-1)
(Comment:en)