| case_id,phase,indication,population,design_summary,endpoints_primary,stats_summary,efficacy_results,safety_results,subgroup_results,multiplicity_note,interim_summary,topline_summary,press_release_headline,investor_call_quote,csr_excerpt,drift_claims_expected,regulatory_acceptability_expected,risk_level,corrected_narrative_expected | |
| CNI2-T01,Phase II,Oncology,"2L metastatic solid tumor","Randomized placebo controlled N=180","PFS","Primary p=0.18 HR 0.82","Primary not significant","SAE higher","PD-L1 high subgroup nominal p","No adjustment","Trend observed","Meaningful benefit supports registration","Meaningful benefit supports registration","We hit it where it counts","Primary missed framed as success|Subgroup promoted beyond evidence|Registration readiness overstated|Safety imbalance softened","not_supportable","high","Primary endpoint did not reach significance. Subgroup findings are exploratory and unadjusted. Safety imbalances require full disclosure. Results support further study not registration intent" | |
| CNI2-T02,Phase III,Cardio,"HFpEF N=920","Non inferiority active control","Composite","NI met; superiority not","NI only","Hypotension higher","No consistent subgroup","Primary only","On track","Improved outcomes vs standard","Improved outcomes vs standard","We have a winner","Non inferiority reframed as superiority|Certainty language beyond stats|Safety risk underplayed","borderline","medium","The study met non inferiority. Superiority was not demonstrated. Hypotension occurred more often. Do not claim improved outcomes beyond the NI finding" | |
| CNI2-T03,Phase II,Immunology,"Moderate UC N=140","Placebo controlled 12w","Remission","Remission p=0.29; secondary nominal p","Primary missed","Infections slightly higher","Secondary signal","No multiplicity","Encouraging signal","Meaningful efficacy demonstrated","Meaningful efficacy demonstrated","Clear efficacy","Primary missed framed as efficacy|Secondary promoted without caveats|Safety minimized","borderline","medium","Primary remission did not differ significantly. Secondary endoscopic signal is nominal without multiplicity adjustment. Safety showed slightly higher infections. Findings are hypothesis generating" | |
| CNI2-T04,Phase III,Neuro,"Early AD N=760","Placebo controlled 18mo","Cognition","p=0.049; missingness higher; sensitivity mixed","Small nominal benefit","ARIA-E higher","APOE4 larger effect","Multiplicity ok; missingness concern","Trending benefit","Supports filing","Definitive proof","Proof of disease modification","Overstatement of certainty|Missingness downplayed|Safety risk softened|APOE4 subgroup promoted","borderline","high","A small nominal difference was observed with higher missingness and mixed sensitivity analyses. ARIA-E increased. Avoid claims of definitive proof. Present full sensitivity and safety context" | |
| CNI2-T05,Phase II,Metabolic,"T2D N=210","Placebo controlled 16w","HbA1c","p=0.11; subgroup post hoc p=0.03","Primary missed","GI AE higher","Subgroup cherry pick","Many subgroups","Signal in right patients","Robust control achieved","Robust control achieved","Works great in right patients","Primary missed framed as robust|Subgroup cherry pick|Safety underplayed","not_supportable","medium","Primary HbA1c did not differ significantly. Post hoc subgroup is exploratory. GI adverse events were more frequent. Results support further study not robust claims" | |
| CNI2-T06,Phase II,Infectious,"Hospital CAP N=160","NI open label","Clinical cure","NI met; mortality higher; QT higher","NI for cure","Mortality imbalance; QT higher","None","NI only","NI likely","Supports broad use","Proved safe","Just as good and safe","Safety imbalance omitted|Broad use overstated|Certainty beyond mixed safety","borderline","high","Non inferiority for clinical cure was met. Mortality and QT prolongation were numerically higher and must be disclosed. Avoid broad use and safety certainty claims" | |
| CNI2-T07,Phase III,Respiratory,"Severe asthma N=520","Active comparator","Exacerbation rate","p=0.33","No significant difference","Anaphylaxis rare","Subgroup trend not significant","Exploratory","Comparable expected","Meaningful reduction","Meaningful reduction","Clinicians will switch","No diff framed as meaningful|Switch claim overreach|Safety signal omitted","borderline","medium","No statistically significant reduction versus comparator. Subgroup trends are not significant. Rare anaphylaxis occurred. Avoid superiority and switching claims" | |
| CNI2-T08,Phase III,Oncology,"NSCLC 1L N=640","Active control","OS","OS p=0.09; secondary PFS p=0.04","OS not significant","Immune AE higher","PD-L1 high OS trend","Hierarchy OS first","PFS possible","Improved survival","Improved survival","We will file fast","Primary OS overclaimed|Secondary PFS promoted|Filing readiness overstated|Safety underplayed","borderline","high","OS did not reach significance. Secondary PFS is nominal within hierarchy and needs caveats. Immune adverse events were more frequent. Avoid definitive survival and filing claims" | |
| CNI2-T09,Phase I,Oncology,"Solid tumor N=36","Early phase","Safety","No PR; SD common; G3 transaminitis","No confirmed responses","Transaminitis G3 11%","SD in indolent tumors","Exploratory","Clean profile","Strong activity","Strong activity","Responses everywhere","Efficacy inflated|Certainty language|Safety minimized","not_supportable","medium","No confirmed partial responses were reported. Stable disease occurred and may reflect tumor biology. Grade 3 transaminitis occurred. Present findings as preliminary without strong activity claims" | |
| CNI2-T10,Phase I,Oncology,"Heme malignancy N=42","Dose escalation","Safety","DLT 19; CRS common incl G3","No efficacy endpoint","CRS common","Responses limited","Exploratory","Manageable CRS","Favorable safety supports rapid expansion","Favorable safety supports rapid expansion","CRS solved","Safety risk softened|Expansion oversold|Efficacy implied beyond design","borderline","high","CRS was common including grade 3 events. Responses are exploratory and limited. Expansion should be cautious and protocol guided with clear safety monitoring" | |