Simulated recruitment data from three sites. Each row represents an SAE. Sites one and two started on 2020-07-01, site three on 2020-09-01.
Format
A data frame with the following variables:
- sae_date
The date that the SAE occured
- record_id
Participant ID
- age
Participant age
- sex
Participant sex
- country
Participant's country
- site
Which site the participant was recruited into
- sae
Description of the SAE
- intervention
Intervention arm
- outcome
SAE outcome (e.g. fatal, sequel, improved, resolved)
- comment
A comment about the SAE
- trt
How was the participant treated?
- class
SAE classification (SUSAR, SADR, ...)
- expected
Was the SAE expected
- devdef
(For device trials) was the SAE a device deficiency?
- devattr
(For device trials) was the SAE attributable to the device?
- devint
(For device trials) was the SAE attributable to the intervention?
- safetymeasure
(For device trials) was the SAE a health hazards that required safety-related measures?
- sae_n
SAE number/identifier
- sae_trtstop
SAE treatment stop
- sae_trtstart
SAE treatment start
- related
Was the SAE related to the intervention