No. |
항목 |
CRF Group |
Visit |
항목 |
Code |
|
|
1 |
* Serious AE |
Adverse Event |
MAE |
Serious |
Hospitalization |
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|
Adverse Event |
MAE |
Serious |
Congenital anomaly or birth defect |
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|
Adverse Event |
MAE |
Serious |
Significant disability |
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|
Adverse Event |
MAE |
Serious |
|
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|
Adverse Event |
MAE |
Serious |
Death |
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|
Adverse Event |
MAE |
Serious |
Life threatening |
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|
2 |
* Random |
Randomization |
V2 |
Is the subject eligible to participate in this clinical trial due to having satisfied all eligibility criteria? |
Yes |
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|
3 |
* AE term |
Adverse Event |
MAE |
Adverse event |
|
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|
4 |
* AE relation |
Adverse Event |
MAE |
Relationship to study treatment |
Related |
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|
Adverse Event |
MAE |
Relationship to study treatment |
Possibly related |
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|
5 |
* Date of informed consent |
Enrollment |
EN |
Date of informed consent |
|
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|
6 |
* Random date |
Randomization |
V2 |
Date of randomization [Click SAVE the bottom of the page for randomization] |
|
Edit |
|
7 |
* Withdrawal by protocol deviation |
Disposition |
MDS |
What was the subject’s status? |
Withdrawal |
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|
|
|
|
|
Edit |
 |