Group: Common

Group: Adverse events

Group: Adverse events

• Event No.

  * Must be an integer.Value must be lower than 1000

  Adverse event

  *

  Start Date

  * Must be a valid date. Correct format is: yyyy-mm-dd

  Is the adverse event still continuing

  No Yes

  *

  Stop Date

  * Must be a valid date. Correct format is: yyyy-mm-dd

  Duration of the adverse event

  * Must be a valid duration. Correct format is: PnYnMnDTnHnMnS

  Was event serious

  No Yes

  *

  Severity

  Mild Moderate Severe

  *

  Is there a reasonable possibility that the AE may have been caused by the study drug

  No Yes

  *

  Action taken with study drug

  None Study drug regimen changed Temporarily stopped study drug Study drug discontinued

  *

  Subject outcome

  Subject remains in study Withdrawn from study Lost to follow-up Death

  *

  ---