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RegisterSignificant differences in AEs [General Statistics]
Dear Helmut
In the study in question seven subjects who received Treatment A (Test Product) reported 15 treatment-emergent adverse events (TEAEs) and 8 TEAEs were reported by eight subjects who received Treatment B (Reference Product) leading to the misinterpretation that the test product causes almost twice number of adverse reactions in comparison with the reference product. A second study with the same formulations but with a higher strength shows the opposite picture in terms of TEAEs: 12 TEAEs were reported by ten of the 36 subjects who received Treatment A (Test Product) and 20 TEAEs reported by thirteen of the 34 subjects who received Treatment B (Reference Product)
study 1: A: 7 subjects with in total 15 TEAE (6 unrelated)
B: 8 subjects with in total 8 TEAE (2 unrelated)
Of the 24 TEAEs reported, the relationship of 1 was judged as “probable”, 14 as “possible”, and 9 as "unrelated". One TEAE that was experienced at an onset time unknown cannot be assigned with certainty to a treatment.
You say you would not pool ADRs (apples with oranges), but evaluate them separately. If done that way you would expect differences between treatments to diminish.
Sorry, I do not understand. If you evaluate seperately then the differences become even bigger, right? see table above
Please advise
Kind regards
Dan
In the study in question seven subjects who received Treatment A (Test Product) reported 15 treatment-emergent adverse events (TEAEs) and 8 TEAEs were reported by eight subjects who received Treatment B (Reference Product) leading to the misinterpretation that the test product causes almost twice number of adverse reactions in comparison with the reference product. A second study with the same formulations but with a higher strength shows the opposite picture in terms of TEAEs: 12 TEAEs were reported by ten of the 36 subjects who received Treatment A (Test Product) and 20 TEAEs reported by thirteen of the 34 subjects who received Treatment B (Reference Product)
study 1: A: 7 subjects with in total 15 TEAE (6 unrelated)
B: 8 subjects with in total 8 TEAE (2 unrelated)
Of the 24 TEAEs reported, the relationship of 1 was judged as “probable”, 14 as “possible”, and 9 as "unrelated". One TEAE that was experienced at an onset time unknown cannot be assigned with certainty to a treatment.
Treatment A B
general 1 -
Nerv 3 2
Musc 2 -
Inv 3 3
GI - 1You say you would not pool ADRs (apples with oranges), but evaluate them separately. If done that way you would expect differences between treatments to diminish.
Sorry, I do not understand. If you evaluate seperately then the differences become even bigger, right? see table above
Please advise
Kind regards
Dan
—
Kind regards and have a nice day
Dr_Dan
Kind regards and have a nice day
Dr_Dan
Complete thread:
- Adverse events Dr_Dan 2011-09-01 11:27
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Significant differences in AEs Helmut 2011-09-01 12:18
- Significant differences in AEsDr_Dan 2011-09-01 15:44
- Significant differences in AEs ElMaestro 2011-09-01 13:40
- Adverse events ElMaestro 2011-09-01 18:12
- Adverse events martin 2011-09-02 11:02
- Significant differences in AEs Helmut 2011-09-01 12:18
Ing. Helmut Schütz