Event Type

Use this feature to specify the inclusion of a particular event in the analysis. By default, all events are included in the analysis.

Available options are listed in the following table:

Option:

Select when you want to:

All event types

• Include any events that may occur on study once informed consent is signed until the patient ends study participation.
• Start date: Consent Date or Enrollment Date or Earliest Visit Start Date
• End date: End of Participation or End of Study or Maximum of (Latest Visit End Date, Latest date for Disposition Events from the DS domain)

Pre treatment events

• Include any events that may occur prior to the first dose of study therapy.
• Start date: Consent Date or Enrollment Date or Earliest Visit Start Date
• End date: First Treatment Date

Treatment emergent adverse events

• Include any events that may occur on or after the first dose of study therapy determined by the treatment arm.
• Start date: First Treatment Date
• End date: End of Participation or End of Study or Maximum of (Latest Visit End Date, Latest date for Disposition Events from the DS domain)

Note: For information about how treatment emergent adverse events (TEAEs) are defined, please refer to How does JMP Clinical determine whether an Event Is a Treatment Emergent Adverse Event?.

On treatment events

• Include events that may occur on or after the first dose of study therapy and before or at the last dose of study therapy.
• Start date: First Treatment Date
• End date: Last Treatment Date

The date of last dosing is normally taken from EXENDTC. If EXENDTC does not exist, the date is taken from EXSTDTC instead.

Off treatment follow up events

• Include events that may occur after the last dose of study therapy.
• Start date: Last Treatment Date
• End date: End of Participation or End of Study or Maximum of (Latest Visit End Date, Latest date for Disposition Events from the DS domain)

The date of last dosing is normally taken from EXENDTC. If EXENDTC does not exist, the date is taken from EXSTDTC instead.

For Screen Failures, the following changes apply:

Option:

Changes

All event types

• No changes

Pre treatment events

• Any events are considered to have occurred before treatment since treatment was never received
• End date: End of Participation or End of Study or Maximum of (Latest Visit End Date, Latest date for Disposition Events from the DS domain)

Treatment emergent adverse events

• Excluded from consideration because no treatment was received.

On treatment events

• Excluded from consideration because no treatment was received.

Off treatment follow up events

• Excluded from consideration because no treatment was received.