Non-serious adverse event
[hidden] Item is not required
text
Diagnosis only (if known) Otherwise Sign/Symptom
text
[hidden] Item is not required
text
[hidden]
text
[hidden]
text
[hidden]
text
Non-serious adverse event, start date
date
AE end time is required for all events starting on ofatumumab treatment days. For all other AEs end Time is optional
time
AE end time is required for all events starting on ofatumumab treatment days
text
Non-serious adverse event, recoverd/resolved, End date
date
AE end time is required for all events starting on ofatumumab treatment days. For all other AEs end Time is optional.
time
Non-serious adverse event, recoverd/resolved with sequelae, End date
date
AE end time is required for all events starting on ofatumumab treatment days. For all other AEs end Time is optional.
time
[hidden] Item is not required This item is optional
text
Record maximum intensity throughout duration of event Item is not required Optional item: This item may be hidden if either the Maximum Grade or Maximum Grade or Intensity item has been used.
text
Record intensity at the onset of the event [hidden] Item is not required Conditional on the use of the Intensity change section. If the section is not used then the item must be hidden. This item may be hidden if either the Grade/Grade or Intensity at onset of event item has been used.
text
Record maximum grade throughout duration of event Item is not required This item may be hidden if either the Maximum Intensity or Maximum Grade or Intensity item has been used. Grade 5 is optional.
text
Record grade at the onset of the event [hidden] Item is not required Conditional on using the Intensity change section. If the section is not used the item must be hidden. This item may be hidden if either the Intensity/Grade or Intensity at onset of event item has been used. Grade 5 is optional
text
Record maximum grade throughout duration of event Item is not required This item may be hidden if either the Maximum Intensity or Maximum Grade item has been used. Grade 5 is optional.
text
Record grade or intensity at the onset of the event [hidden] Conditional on the use of the Intensity change section. If the section is not used then the item must be hidden. This item may be hidden if either the Intensity or Grade at onset of event item has been used. Grade 5 is optional
text
Action Taken with Investigational Product as Result of the AE
text
Item is not required
boolean
Use best judgment at initial entry. May be amended when additional information becomes available. If the study has multiple IP then remove Yes and keep Yes, select appropriate investigational product(s)' and set selection value to Y. Otherwise remove Yes, select appropriate investigational product(s) and keep Yes.
boolean
[hidden] Item is not required If AE start and end time are used this item must be hidden.
durationDatetime
[hidden] Item is not required
durationDatetime