Versions Compared

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

...

Dataset wrap
Rowcaps
Row 1:Data for the screening visit was gathered over the course of six 6 days.
Row 2:The visit called "DAY 1" started and ended as planned, on Day day 1.
Row 3:The visit scheduled for Day day 8 occurred one day early, on Day day 7.
Row 4:The visit called "WEEK 2" started and ended as planned, on Day day 15.
Row 5:Shows an unscheduled visit. SVUPDES provides the information that this visit dealt with evaluation of an adverse event. Since this visit was not planned, VISITDY was not populated. The sponsor applicant chose not to populate VISIT. VISITNUM was populated, probably because the data collected at this encounter is in a Findings domain such as EG, LB, or VS, in which VISIT is treated as an important timing variable.
Row 6:This subject had their last visit, a follow-up visit on study day 26, eight 8 days after the unscheduled visit, but well before the scheduled visit day of 71.
Dataset2
RowSTUDYIDDOMAINUSUBJIDVISITNUMVISITVISITDYSVSTDTCSVENDTCSVSTDYSVENDYSVUPDES
1123456VSV1011SCREEN-72006-01-152006-01-20-6-1
2123456VSV1012DAY 112006-01-212006-01-2111
3123456VSV1013WEEK 182006-01-272006-01-2777
4123456VSV1014WEEK 2152006-02-042006-02-041515
5123456VSV1014.1

2006-02-072006-02-071818Evaluation of AE
6123456VSV1018FOLLOW-UP712006-02-152006-02-152626