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Temporal Relationship View

Hypotension (MedDRA PT 10021097) — Day-by-day event distribution vs. diagnostic procedure schedule

Temporal Analysis Competitive Landscape

Hypotension events vs. RHC (Right Heart Catheterization — diagnostic test) procedures by day

Hypotension events (n=105) RHC procedures (by day) Diagnostic procedure window (Day 5–15)
In plain terms: most of the low blood pressure events happened right after a diagnostic test — right heart catheterization (RHC) — that is itself known to cause temporary low blood pressure in this patient population. This means the signal may reflect the test, not the drug.
🔍 iSAT Finding

70% of hypotension events (n=73 of 105) occurred within 7 days of a right heart catheterization (RHC — a diagnostic test using a thin tube to measure heart pressures) — a pattern identified across 3 documents.

[1] PSUR [2] CIOMS VEL-0047 [4] Literature 2023
87% confidence Confidence score based on temporal overlap between RHC procedure dates and hypotension onset, validated against published literature (Varela et al., J Pulm Med 2023, 41(3):214–228) temporal overlap analysis

Key numbers

12.4%
Unadjusted rate
~3.8%
Drug-attributable

ERA class expectation: 3–5%

See the Evidence → Competitive Context