fix: updated scenarios and added a new one

4 files changed, 274 insertions, 0 deletions

diff --git a/scenarios/pharma_trial/data/data/aethon_rivamod_trial.txt b/scenarios/pharma_trial/data/data/aethon_rivamod_trial.txt
new file mode 100644
index 0000000..adb7bdf
--- /dev/null
+++ b/scenarios/pharma_trial/data/data/aethon_rivamod_trial.txt
@@ -0,0 +1,70 @@
+AETHON PHARMACEUTICALS — PHASE III TRIAL RESULTS: RIVAMOD (RVM-305)
+
+**Indication:** Moderate-to-severe chronic inflammatory arthritis
+**Design:** Randomized, double-blind, placebo-controlled, 52-week study
+**Enrollment:** N=2,103 (1,052 Rivamod, 1,051 placebo)
+**Sites:** 156 centers across North America, Europe, and Latin America
+
+---
+
+EFFICACY ENDPOINTS
+
+Primary Endpoint — ACR50 Response at Week 24:
+  Rivamod: 42% (442/1,052) vs Placebo: 18% (189/1,051)
+  Absolute difference: 24 percentage points (95% CI: 20.1–27.9, p<0.001)
+
+Secondary Endpoint — DAS28-CRP Remission at Week 52:
+  Rivamod: 28% (295/1,052) vs Placebo: 7% (74/1,051)
+  p<0.001
+
+Patient-Reported Outcomes — HAQ-DI Change from Baseline:
+  Rivamod: -0.51 (SD 0.40) vs Placebo: -0.15 (SD 0.36)
+  Clinically meaningful improvement threshold: -0.22
+
+---
+
+SAFETY AND ADVERSE EVENTS
+
+Serious Adverse Events (SAEs):
+  Rivamod: 5.9% (62/1,052) vs Placebo: 5.4% (57/1,051)
+  Near-parity with placebo arm
+
+Treatment-Related Deaths:
+  Rivamod arm: 0 deaths
+  Placebo arm: 0 deaths
+
+Most Common Adverse Event:
+  Nausea: Rivamod 15.2% vs Placebo 4.8% (mild-to-moderate severity)
+  Headache: Rivamod 8.3% vs Placebo 7.1%
+
+Cardiovascular Safety:
+  MACE: Rivamod 0.6% vs Placebo 0.5%
+  No cardiovascular signal detected by independent DSMB review
+
+Hepatic Safety:
+  ALT elevations >3× ULN: Rivamod 1.1% vs Placebo 0.9%
+  No hepatic safety signal identified
+
+Serious Infections:
+  Rivamod: 1.9% vs Placebo: 1.5%
+  No opportunistic infections reported
+
+Trial Discontinuation Due to Adverse Events:
+  Rivamod: 6.7% (70/1,052) vs Placebo: 4.9% (52/1,051)
+
+---
+
+CONCLUSION
+
+Rivamod demonstrated robust efficacy with a favorable safety profile closely
+approximating placebo rates for serious adverse events. No treatment-related
+deaths, no cardiovascular or hepatic signals, and no opportunistic infections
+were observed during the 52-week study. The primary adverse event (nausea)
+was predominantly mild and did not lead to significant treatment discontinuation.
+
+This safety profile positions Rivamod favorably among current and emerging
+therapies for moderate-to-severe chronic inflammatory arthritis.
+
+TRIAL REGISTRATION: NCT05719402
+SPONSOR: Aethon Pharmaceuticals, Inc.
+DATA CUTOFF: October 12, 2025
diff --git a/scenarios/pharma_trial/data/data/fda_advisory_note.txt b/scenarios/pharma_trial/data/data/fda_advisory_note.txt
new file mode 100644
index 0000000..6d2553e
--- /dev/null
+++ b/scenarios/pharma_trial/data/data/fda_advisory_note.txt
@@ -0,0 +1,62 @@
+FDA DIVISION OF RHEUMATOLOGY AND INFLAMMATION — ADVISORY COMMUNICATION
+Document Classification: Pre-Decision Review Communication
+Date: November 3, 2025
+
+RE: Zyphranol (ZYP-401, VitaNova Therapeutics) — Phase III Safety Review
+
+---
+
+The Division has completed its preliminary review of the Phase III clinical
+trial data submitted by VitaNova Therapeutics for Zyphranol (ZYP-401) in the
+treatment of moderate-to-severe chronic inflammatory arthritis.
+
+The Division notes the following safety concerns from the submitted data:
+
+1. SERIOUS ADVERSE EVENT RATE
+   The observed SAE rate of 14.2% in the Zyphranol arm significantly exceeds
+   the placebo rate (6.1%) and is notably higher than the class average for
+   approved biologic therapies in this indication (typically 6-8%). This
+   disparity warrants further characterization.
+
+2. TREATMENT-RELATED MORTALITY
+   Three treatment-related deaths were reported in the Zyphranol arm (2 cardiac
+   events, 1 hepatic failure) versus zero in the placebo arm. While the overall
+   mortality rate is within the range observed for this patient population, the
+   causal relationship to study drug requires careful evaluation.
+
+3. CARDIOVASCULAR SAFETY SIGNAL
+   The MACE rate of 2.8% versus 0.9% placebo (HR 3.24, 95% CI: 1.47–7.15)
+   represents a statistically significant cardiovascular signal. The finding
+   of 5.1% MACE in the >65 subgroup is of particular concern and may require
+   a BOXED WARNING consideration if confirmed in follow-up data.
+
+4. HEPATOTOXICITY
+   ALT elevations >3× ULN occurring in 8.7% of treated patients suggest the
+   need for MANDATORY LIVER FUNCTION MONITORING during treatment. The fatal
+   hepatic failure case (Patient 3) underscores this concern.
+
+5. DISCONTINUATION RATE
+   The 18.3% treatment discontinuation rate due to adverse events is
+   substantially above the typical range for this drug class (6-10%) and
+   may impact real-world effectiveness assessments.
+
+---
+
+REQUIRED ACTIONS
+
+The Division has formally requested that VitaNova Therapeutics submit the
+following before the advisory committee meeting scheduled for Q2 2026:
+
+  (a) 6-month post-trial cardiac safety follow-up data for all trial
+      participants
+  (b) Detailed hepatic event adjudication by an independent committee
+  (c) Updated benefit-risk assessment incorporating the above data
+
+This communication does not constitute a final regulatory determination.
+Regulatory review is ongoing.
+
+---
+
+Division Director: [Redacted]
+Office of New Drugs, CDER
+U.S. Food and Drug Administration
diff --git a/scenarios/pharma_trial/data/data/meridian_celvara_trial.txt b/scenarios/pharma_trial/data/data/meridian_celvara_trial.txt
new file mode 100644
index 0000000..6364d08
--- /dev/null
+++ b/scenarios/pharma_trial/data/data/meridian_celvara_trial.txt
@@ -0,0 +1,63 @@
+MERIDIAN BIOSCIENCES — PHASE III TRIAL RESULTS: CELVARA (CLV-220)
+
+**Indication:** Moderate-to-severe chronic inflammatory arthritis
+**Design:** Randomized, double-blind, active-controlled vs methotrexate, 48-week study
+**Enrollment:** N=1,524 (762 Celvara, 762 methotrexate)
+**Sites:** 98 centers across North America and Europe
+
+---
+
+EFFICACY ENDPOINTS
+
+Primary Endpoint — ACR50 Response at Week 24:
+  Celvara: 39% (297/762) vs Methotrexate: 32% (244/762)
+  Absolute difference: 7 percentage points (95% CI: 2.3–11.7, p=0.018)
+
+Secondary Endpoint — DAS28-CRP Remission at Week 48:
+  Celvara: 24% (183/762) vs Methotrexate: 19% (145/762)
+  p=0.021
+
+Patient-Reported Outcomes — HAQ-DI Change from Baseline:
+  Celvara: -0.42 (SD 0.39) vs Methotrexate: -0.35 (SD 0.37)
+  Clinically meaningful improvement threshold: -0.22
+
+---
+
+SAFETY AND ADVERSE EVENTS
+
+Serious Adverse Events (SAEs):
+  Celvara: 7.3% (56/762) vs Methotrexate: 8.9% (68/762)
+
+Treatment-Related Deaths:
+  Celvara arm: 0 deaths
+  Methotrexate arm: 0 deaths
+
+Injection Site Reactions:
+  Celvara: 12.4% (mild-moderate, self-resolving)
+  Most common: erythema (8.1%), pruritus (4.3%)
+
+Upper Respiratory Infections:
+  Celvara: 9.8% vs Methotrexate: 11.2%
+  No serious respiratory events in either arm
+
+Hepatic Safety:
+  ALT elevations >3× ULN: Celvara 1.8% vs Methotrexate 5.4%
+  Celvara demonstrated a more favorable hepatic profile
+
+Trial Discontinuation Due to Adverse Events:
+  Celvara: 8.1% (62/762) vs Methotrexate: 10.4% (79/762)
+
+---
+
+CONCLUSION
+
+Celvara demonstrated statistically significant, modest superiority over
+methotrexate (standard of care) in ACR50 response with a comparable-to-
+favorable safety profile. No treatment-related deaths and no new safety
+signals were identified during the 48-week trial period. The most common
+adverse events were injection site reactions, which were mild and self-
+resolving.
+
+TRIAL REGISTRATION: NCT05623187
+SPONSOR: Meridian Biosciences, Ltd.
+DATA CUTOFF: August 15, 2025
diff --git a/scenarios/pharma_trial/data/data/vitanova_zyphranol_trial.txt b/scenarios/pharma_trial/data/data/vitanova_zyphranol_trial.txt
new file mode 100644
index 0000000..0d7bb7c
--- /dev/null
+++ b/scenarios/pharma_trial/data/data/vitanova_zyphranol_trial.txt
@@ -0,0 +1,79 @@
+VITANOVA THERAPEUTICS — PHASE III TRIAL RESULTS: ZYPHRANOL (ZYP-401)
+
+**Indication:** Moderate-to-severe chronic inflammatory arthritis
+**Design:** Randomized, double-blind, placebo-controlled, 52-week study
+**Enrollment:** N=1,847 (926 Zyphranol, 921 placebo)
+**Sites:** 142 centers across North America, Europe, and Asia-Pacific
+
+---
+
+EFFICACY ENDPOINTS
+
+Primary Endpoint — ACR50 Response at Week 24:
+  Zyphranol: 47% (435/926) vs Placebo: 21% (193/921)
+  Absolute difference: 26 percentage points (95% CI: 21.8–30.2, p<0.001)
+
+Secondary Endpoint — DAS28-CRP Remission at Week 52:
+  Zyphranol: 31% (287/926) vs Placebo: 9% (83/921)
+  p<0.001
+
+Patient-Reported Outcomes — HAQ-DI Change from Baseline:
+  Zyphranol: -0.58 (SD 0.41) vs Placebo: -0.19 (SD 0.38)
+  Clinically meaningful improvement threshold: -0.22
+
+---
+
+SAFETY AND ADVERSE EVENTS
+
+Serious Adverse Events (SAEs):
+  Zyphranol: 14.2% (132/926) vs Placebo: 6.1% (56/921)
+
+Treatment-Related Deaths:
+  Zyphranol arm: 3 deaths
+    - Patient 1: Male, 71, acute myocardial infarction (Day 187)
+    - Patient 2: Female, 68, sudden cardiac death (Day 243)
+    - Patient 3: Male, 58, acute hepatic failure (Day 312)
+  Placebo arm: 0 deaths
+
+Hepatic Safety — ALT Elevations >3× Upper Limit of Normal (ULN):
+  Zyphranol: 8.7% (81/926) vs Placebo: 1.2% (11/921)
+  Grade 3-4 hepatic events: 2.1% vs 0.2%
+
+Major Adverse Cardiovascular Events (MACE):
+  Zyphranol: 2.8% (26/926) vs Placebo: 0.9% (8/921)
+  Hazard ratio: 3.24 (95% CI: 1.47–7.15)
+
+Serious Infections Requiring Hospitalization:
+  Zyphranol: 4.1% (38/926) vs Placebo: 1.8% (17/921)
+  Including 2 cases of opportunistic infection (PML suspected in 1 patient)
+
+Trial Discontinuation Due to Adverse Events:
+  Zyphranol: 18.3% (170/926) vs Placebo: 5.2% (48/921)
+
+---
+
+POST-HOC SUBGROUP ANALYSIS
+
+Age-Stratified Cardiovascular Risk:
+  Patients ≤65 years — MACE: 1.4% (Zyphranol) vs 0.7% (placebo)
+  Patients >65 years — MACE: 5.1% (Zyphranol) vs 1.1% (placebo)
+  Interaction p-value: 0.003
+
+The FDA Division of Rheumatology has requested submission of additional
+6-month post-trial cardiac safety monitoring data before the scheduled
+advisory committee review.
+
+---
+
+CONCLUSION
+
+Zyphranol demonstrated statistically significant and clinically meaningful
+improvement across primary and secondary efficacy endpoints in patients with
+moderate-to-severe chronic inflammatory arthritis. The safety profile warrants
+careful benefit-risk evaluation, particularly regarding cardiovascular events,
+hepatic enzyme elevations, and the three treatment-related deaths observed
+during the trial period.
+
+TRIAL REGISTRATION: NCT05847291
+SPONSOR: VitaNova Therapeutics, Inc.
+DATA CUTOFF: September 30, 2025