Changes from SDTM v2.0 to SDTM v2.1

The variable label, definition, and/or notes associated with the following variable has been changed in the following sections.

• Section 3.1.1 The Interventions Observation Class
  • --TRT
  • --RSDISC
  • --DOSFRM
  • --DOSFRQ
  • --DOSTOT
  • --DOSRGM
• Section 3.1.2 The Events Observation Class
  • --REL
  • --ACNOTH
  • --ACN
• Section 3.1.3 The Findings Observation Class
  • --SPEC
• Section 3.1.5 Timing Variables for All Classes
  • --XENDY
  • --XSTDY
  • --XDY
• Section 3.2.1 Special-Purpose Observation Structures
  • ACTARMUD
  • RFXENDTC
  • RFXSTDTC
  • RFENDTC
  • RFSTDTC

New variables have been added to the following sections. Many of these are restricted in use, as noted in the Usage Restrictions column.

• Section 3.1.4, Identifiers for All Classes
  • GNTXAID
  • SPTOBID

The following new section was added:

• Section 6.x, Related References Dataset