case_id
stringclasses 10
values | phase
stringclasses 3
values | indication
stringclasses 7
values | population
stringclasses 10
values | design_summary
stringclasses 10
values | endpoints_primary
stringclasses 10
values | stats_summary
stringclasses 10
values | efficacy_results
stringclasses 10
values | safety_results
stringclasses 10
values | subgroup_results
stringclasses 10
values | multiplicity_note
stringclasses 10
values | interim_summary
stringclasses 10
values | topline_summary
stringclasses 10
values | press_release_headline
stringclasses 10
values | investor_call_quote
stringclasses 10
values | csr_excerpt
stringclasses 10
values | drift_claims_expected
stringclasses 10
values | regulatory_acceptability_expected
stringclasses 2
values | risk_level
stringclasses 2
values | corrected_narrative_expected
stringclasses 10
values |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
CNI2-001
|
Phase II
|
Oncology
|
2L metastatic solid tumor
|
Randomized double blind placebo controlled 1:1 N=180 24w
|
PFS
|
Primary p=0.18 HR 0.82 CI 0.62-1.09; OS exploratory
|
PFS not significant; ORR +3% absolute
|
SAE 14% vs 9%; G3+ 28% vs 18%
|
Subgroup PD-L1 high HR 0.62 p=0.04 post hoc
|
Multiple subgroups; no adjustment
|
Interim: trend observed on PFS with acceptable safety
|
Topline: clinically meaningful PFS benefit supports registration intent
|
Topline results demonstrate meaningful benefit and momentum
|
We basically hit the endpoint in the patients that matter
|
CSR: Primary endpoint did not reach significance; safety signals include higher SAE
|
Primary missed framed as success|Subgroup promoted beyond evidence|Registration readiness overstated|Safety imbalance softened
|
not_supportable
|
high
|
The primary endpoint did not meet statistical significance for PFS. Exploratory analyses including PD-L1 high subgroup are hypothesis generating and not adjusted for multiplicity. Safety showed higher SAE and G3+ rates versus placebo. Results support further study with prespecified endpoints and risk mitigation rather than registration intent
|
CNI2-002
|
Phase III
|
Cardio
|
HFpEF N=920
|
Randomized active control non inferiority 52w
|
Composite CV death or HF hospitalization
|
Met non inferiority margin; superiority p=0.21
|
Non inferiority met; no superiority
|
AE similar; hypotension higher 8% vs 4%
|
No consistent subgroup benefit
|
Multiplicity controlled for primary only
|
Interim: on track for pivotal readout
|
Topline: improved outcomes vs standard of care
|
New therapy improves outcomes for HFpEF patients
|
We have a winner and the market will see it
|
CSR: Non inferiority met; superiority not demonstrated; hypotension increased
|
Non inferiority reframed as superiority|Certainty language beyond stats|Safety risk underplayed
|
borderline
|
medium
|
The study met its non inferiority objective for the primary composite endpoint. Superiority was not demonstrated. Adverse events were broadly similar, with higher hypotension versus control. Findings support non inferiority positioning with clear safety labeling and no superiority claims
|
CNI2-003
|
Phase II
|
Immunology
|
Moderate UC N=140
|
Randomized placebo controlled 12w
|
Clinical remission at week 12
|
Remission 18% vs 12% p=0.29; secondary endoscopic improvement p=0.04
|
Primary not significant; secondary signal
|
Serious infection 3% vs 1%
|
Subgroup biologic naive p=0.06
|
Secondary not multiplicity adjusted
|
Interim: encouraging endoscopic signal
|
Topline: meaningful efficacy demonstrated
|
Meaningful efficacy demonstrated in ulcerative colitis
|
We showed clear efficacy and a clean profile
|
CSR: Primary not significant; endoscopic secondary nominal p; infections slightly higher
|
Primary missed framed as efficacy|Secondary promoted without caveats|Safety minimized
|
borderline
|
medium
|
Clinical remission at week 12 did not differ significantly versus placebo. A nominal secondary endoscopic improvement signal was observed without multiplicity adjustment and should be interpreted cautiously. Serious infections were numerically higher. Results support refinement of dose and population and a larger confirmatory study with prespecified hierarchy
|
CNI2-004
|
Phase I
|
Oncology
|
Advanced hematologic malignancy N=42
|
Open label dose escalation
|
DLT rate and safety
|
DLT 19%; MTD not reached
|
No efficacy endpoint; responses observed 6 PR
|
CRS any grade 31%; G3 CRS 7%
|
Responses in dose level 3 only
|
Exploratory only
|
Interim: manageable CRS observed
|
Topline: favorable safety supports rapid expansion
|
Favorable safety supports rapid expansion
|
CRS is basically solved and we can scale dosing
|
CSR: CRS common including G3; responses limited; no MTD
|
Safety risk softened|Expansion oversold|Efficacy implied beyond design
|
borderline
|
high
|
In dose escalation, CRS was common including grade 3 events, and the MTD was not reached. Limited partial responses were observed in a subset at one dose level and are exploratory. Safety supports continued cautious escalation and protocol guided expansion with clear CRS management and monitoring
|
CNI2-005
|
Phase III
|
Neuro
|
Early AD N=760
|
Randomized placebo controlled 18mo
|
Change in cognitive scale
|
Difference -0.8 points p=0.049; missingness 22% vs 14%
|
Nominal p with high missingness; sensitivity mixed
|
ARIA-E 12% vs 3%
|
APOE4 carriers larger effect
|
Multiplicity controlled; missing data sensitivity preplanned
|
Interim: trending toward benefit
|
Topline: statistically significant slowing supports filing
|
Statistically significant slowing of decline
|
We have definitive proof of disease modification
|
CSR: nominal significance; missingness higher; ARIA-E increased; sensitivity mixed
|
Overstatement of certainty|Missingness downplayed|Safety risk softened|APOE4 subgroup promoted
|
borderline
|
high
|
The primary endpoint showed a small nominally significant difference with higher missingness in the active arm and mixed sensitivity analyses. ARIA-E occurred more frequently. Subgroup patterns including APOE4 require cautious interpretation within the prespecified analysis plan. Results may support discussion with regulators with full sensitivity and safety disclosure rather than definitive efficacy claims
|
CNI2-006
|
Phase II
|
Metabolic
|
T2D N=210
|
Randomized placebo controlled 16w
|
HbA1c change
|
-0.4 vs -0.2 p=0.11
|
Primary not significant
|
GI AE 22% vs 10%
|
Subgroup baseline HbA1c high p=0.03 post hoc
|
Many subgroups unadjusted
|
Interim: signal in high baseline HbA1c
|
Topline: robust glycemic control achieved
|
Robust glycemic control achieved
|
If you look at the right patients it works great
|
CSR: Primary not significant; GI AE higher; subgroup post hoc
|
Primary missed framed as robust|Subgroup cherry pick|Safety underplayed
|
not_supportable
|
medium
|
HbA1c reduction did not differ significantly versus placebo on the primary analysis. A post hoc signal in higher baseline HbA1c subgroup is hypothesis generating and not adjusted for multiplicity. GI adverse events were more frequent. Results support further dose and population selection work before confirmatory trials
|
CNI2-007
|
Phase III
|
Respiratory
|
Severe asthma N=520
|
Randomized active comparator 52w
|
Annual exacerbation rate
|
Rate ratio 0.92 p=0.33
|
No significant difference
|
Anaphylaxis 0.6% vs 0%
|
Eosinophil high subgroup RR 0.70 p=0.07
|
Subgroup exploratory
|
Interim: comparable efficacy expected
|
Topline: meaningful reduction in exacerbations
|
Meaningful reduction in exacerbations
|
Clinicians will switch once they see this
|
CSR: no significant difference; rare anaphylaxis events
|
No diff framed as meaningful|Switch claim overreach|Safety signal omitted
|
borderline
|
medium
|
The study did not demonstrate a statistically significant reduction in annual exacerbations versus comparator. Exploratory subgroup trends were not significant. Rare anaphylaxis events occurred with active treatment. Results do not support claims of superior exacerbation reduction and require clear safety communication
|
CNI2-008
|
Phase II
|
Infectious
|
Hospital CAP N=160
|
Randomized open label non inferiority
|
Clinical cure day 14
|
Non inferiority met; mortality higher 6% vs 2%
|
NI met; mortality imbalance
|
QT prolongation 9% vs 3%
|
No clear subgroup
|
Primary NI only
|
Interim: NI likely
|
Topline: successful trial supports broad use
|
Successful trial supports broad use
|
We proved it is just as good and safe
|
CSR: NI met; mortality imbalance; QT prolongation higher
|
Safety imbalance omitted|Broad use overstated|Certainty beyond mixed safety
|
borderline
|
high
|
The trial met its non inferiority objective for clinical cure. Mortality and QT prolongation were numerically higher in the active arm and require careful evaluation. Conclusions should state NI for cure with explicit safety imbalances and a plan for further safety characterization before broad claims
|
CNI2-009
|
Phase I
|
Oncology
|
Solid tumor N=36
|
Open label expansion cohorts
|
Safety and PK
|
No DLT; exposure variable
|
Stable disease 14/36; no PR
|
Transaminitis G3 11%
|
Stable disease in slow growing tumors
|
Exploratory
|
Interim: clean safety profile
|
Topline: strong anti tumor activity
|
Strong anti tumor activity observed
|
We are seeing responses everywhere
|
CSR: no PR; stable disease common; transaminitis noted
|
Efficacy inflated|Certainty language|Safety minimized
|
not_supportable
|
medium
|
In early phase evaluation, no DLTs were observed, and exposure was variable. No confirmed partial responses were reported; stable disease occurred in some patients and may reflect disease biology. Grade 3 transaminitis occurred. Conclusions should avoid claims of strong activity and present these findings as preliminary
|
CNI2-010
|
Phase III
|
Oncology
|
NSCLC 1L N=640
|
Randomized active control
|
OS
|
OS HR 0.88 p=0.09; PFS HR 0.86 p=0.04 secondary
|
Primary OS not significant; secondary PFS nominal
|
Immune AE 21% vs 14%
|
Subgroup PD-L1 high OS HR 0.74 p=0.06
|
Secondary nominal; hierarchy prespecified OS first
|
Interim: PFS benefit possible
|
Topline: improved survival and disease control
|
Improved survival in first line NSCLC
|
We improved survival and will file fast
|
CSR: OS not significant; PFS nominal; immune AE higher
|
Primary OS overclaimed|Secondary PFS promoted|Filing readiness overstated|Safety underplayed
|
borderline
|
high
|
Overall survival did not reach statistical significance. A nominal secondary PFS difference was observed within the hierarchical framework and should be reported with appropriate caveats. Immune related adverse events were more frequent. Results support continued evaluation and regulator discussion without definitive survival claims
|
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.