Table 2.
THIN characteristics | VigiBase characteristics | |||||
---|---|---|---|---|---|---|
Chronograph pattern | No. of combinations | Median and range of first prescriptions* | Median and range of combinations within 1/12 months | No. combinations with serious terms** / new drug*** with serious term** | First‐year drug**** | |
1 month | 12 months | |||||
Elevated exclusively after prescription | 2 | n = 2213 and 82 593 | n = 1 and 1 | n = 5 and 3 | 0/0 | 2002/1968 |
Elevated before prescription | 24 | M = 13 271 | M = 7.5 | M = 44 | 11/2 | M = 1997 |
R = 103–884 258 | R = 0–521 | R = 0–3037 | R = 1968–2010 | |||
No elevation before or after prescription | 34 | M = 12 186 | M = 2 | M = 9 | 12/0 | M = 1984 |
R = 158–602 655 | R = 0–120 | R = 0–1170 | R = 1968–2007 |
M = median, R = range.
First prescriptions denote prescriptions without any record of the same substance 13 months prior to the prescription in a patient's record history.
Serious terms are defined by using the WHO‐Adverse Reaction Terminology critical terms, that is, a subset of terms that have been classified to be indicative of a serious disease state.
New drug is a drug entered in VigiBase for the first time during the past 5 years.
First year when drug was entered in VigiBase.