Adverse event example data set

The adverse example dataset is based on a clinical trial of an active treatment for eczema compared to placebo in adolescents that are unresponsive to standard care.

The primary outcome was a continuous outcome that measured the extent and severity of eczema at 6 months.

Participants were treated with either active treatment or placebo for 6 months and then followed-up for a further 6 months.

AEs were monitored and collected for the entire 12 month study period.

Adverse event profile

Objective: to describe and compare the Adverse Event profiles between treatment arms.

Overview of the dataset

Participants were randomised between November 2016 – June 2017

Placebo n=29, Intervention n=32

The dataset contains multiple observations per subject

The following variables are measured at randomisation:

• usubjid: unique subject identifier
• arm: treatment assignment name
• armn: treatment assignment numeric (0: placebo; 1:intervention)
• rando_date: date of randomisation (yyyymmdd)

Additional variables measured throughout study (including treatment and follow-up period)

• repeatnum: unique event identifier within usubjid
• aept: adverse event code at preferred term/lower level
• aebodsys: adverse event code at body system/higher level
• aesev: adverse event severity grade (mild, moderate, severe)
• aesevn: adverse event severity grade number (1: mild, 2: moderate, 3: severe)
• aeser: serious adverse event (no, yes)
• aesern: serious adverse event (0: no, 1: yes)
• aestdat: adverse event start date (yyyymmdd)
• aeeddat: adverse event end date (yyyymmdd)
• dur: adverse event duration (days)

Downloading the data

To download the raw csv file click here and press right click.

NOTE to download a single data set as a csv file, click on the raw button and save the file. The following link describes the process in further detail.