PBRER Report printed from ARGUS NATIVE using PBRER format and printed from ARGUS UI using BIP have different outputs for Section 6.2 and Section 6.3 (Doc ID 2212534.1)

Last updated on JULY 13, 2023

Applies to:

Symptoms

On Applications Oracle Life Sciences Argus Safety Version : 8.0.1

PBRER Report printed from ARGUS NATIVE using PBRER format and printed from ARGUS UI using BIP appears to have different outputs for Section 6.2 and Section 6.3.

After some analysis, it is seen that PBRER Report using BIP is printing only cases with Adverse drug reactions (causality related) whereas using Argus Native is using cases with Adverse events (for section 6.2)
and reactions (for section 6.3).


Example: PBRER 6.2 from ARGUSNATIVE has 0 cases and 6.3 from Native has 601 cases.

From BIP, 6.2 section has data and 6.3 has no data.

However, section Case Numbers considered in Numbers of Adverse Drug Reactions by Term from Post-Marketing Sources on page # 11 of the PDF lists cases.

Question: Why are these cases not included in 6.3 tabulation of PBRER?

Changes

Cause

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