Datasets:

ClarusC64
/

clinical-early-safety-signal-detection-v0.1

uid stringclasses 10 values	dataset_id stringclasses 1 value	year int64 2.02k 2.02k	trial_phase stringclasses 3 values	therapeutic_area stringclasses 5 values	drug_class stringclasses 3 values	exposure_days_median int64 14 168	n_treat int64 48 600	n_control int64 16 300	ae_term stringclasses 5 values	seriousness stringclasses 2 values	rate_treat float64 0.01 0.25	rate_control float64 0 0.12	rate_diff float64 -0.02 0.19	dose_response stringclasses 2 values	onset_cluster stringclasses 2 values	alt_explanation_present stringclasses 2 values	sponsor_narrative_summary stringclasses 10 values	question stringclasses 1 value	ground_truth_label stringclasses 2 values	ground_truth_rationale stringclasses 10 values	outcome_signal stringclasses 6 values	source_citation stringclasses 1 value
AES-TR-001	clinical-early-safety-signal-detection-v0.1	2,023	Phase 2	Cardiology	small_molecule	28	120	60	ALT_increase	serious	0.18	0.05	0.13	yes	yes	no	Narrative says sporadic lab noise.	Is there an early safety signal. Answer signal or no_signal.	signal	Higher rate vs control with dose response and clustered onset.	dsmb_action_likely	Synthetic
AES-TR-002	clinical-early-safety-signal-detection-v0.1	2,023	Phase 2	Cardiology	small_molecule	28	120	60	ALT_increase	serious	0.07	0.06	0.01	no	no	yes	Narrative says consistent with background metabolic risk.	Is there an early safety signal. Answer signal or no_signal.	no_signal	Rates similar and alternative explanation present.	monitor_only	Synthetic
AES-TR-003	clinical-early-safety-signal-detection-v0.1	2,022	Phase 1	Oncology	biologic	14	48	16	infusion_reaction	moderate	0.25	0.06	0.19	yes	yes	no	Narrative calls expected class effect but provides no mitigation plan.	Is there an early safety signal. Answer signal or no_signal.	signal	Large arm difference plus dose response and immediate onset after infusion.	protocol_amendment_risk	Synthetic
AES-TR-004	clinical-early-safety-signal-detection-v0.1	2,022	Phase 1	Oncology	biologic	14	48	16	infusion_reaction	moderate	0.1	0.12	-0.02	no	no	yes	Narrative says reactions driven by premed changes across sites.	Is there an early safety signal. Answer signal or no_signal.	no_signal	No excess vs control and site change explains pattern.	monitor_only	Synthetic
AES-TR-005	clinical-early-safety-signal-detection-v0.1	2,021	Phase 2	Neurology	small_molecule	56	200	100	suicidal_ideation	serious	0.04	0	0.04	no	yes	no	Narrative says unrelated psychosocial stressors.	Is there an early safety signal. Answer signal or no_signal.	signal	Zero in control with clustered onset after start is concerning.	risk_mitigation_needed	Synthetic
AES-TR-006	clinical-early-safety-signal-detection-v0.1	2,021	Phase 2	Neurology	small_molecule	56	200	100	suicidal_ideation	serious	0.01	0.01	0	no	no	yes	Narrative says baseline psychiatric history balanced and events pre-date dosing.	Is there an early safety signal. Answer signal or no_signal.	no_signal	Equal rates and events not temporally linked to dosing.	monitor_only	Synthetic
AES-TR-007	clinical-early-safety-signal-detection-v0.1	2,024	Phase 2	Endocrinology	peptide	84	160	80	hypoglycemia	serious	0.14	0.03	0.11	yes	yes	no	Narrative says improved glycemic control explains events without adjustment plan.	Is there an early safety signal. Answer signal or no_signal.	signal	Excess events plus dose response needs action.	dose_change_likely	Synthetic
AES-TR-008	clinical-early-safety-signal-detection-v0.1	2,024	Phase 2	Endocrinology	peptide	84	160	80	hypoglycemia	serious	0.05	0.04	0.01	no	no	yes	Narrative says rescue meds and diet counseling changed mid study.	Is there an early safety signal. Answer signal or no_signal.	no_signal	Small difference with clear confound.	monitor_only	Synthetic
AES-TR-009	clinical-early-safety-signal-detection-v0.1	2,020	Phase 3	Rheumatology	biologic	168	600	300	serious_infection	serious	0.09	0.04	0.05	yes	yes	no	Narrative says expected immunomodulation but downplays early clustering.	Is there an early safety signal. Answer signal or no_signal.	signal	Higher infection rate with early clustering and dose response.	label_warning_risk	Synthetic
AES-TR-010	clinical-early-safety-signal-detection-v0.1	2,020	Phase 3	Rheumatology	biologic	168	600	300	serious_infection	serious	0.05	0.05	0	no	no	yes	Narrative says infection rates match local seasonal wave across both arms.	Is there an early safety signal. Answer signal or no_signal.	no_signal	No arm difference and plausible external driver.	monitor_only	Synthetic

What this dataset does

You receive

exposure and arm sizes

adverse event term and seriousness

rates in treatment and control

dose response and onset clustering

alternative explanation flag

sponsor narrative summary

You decide

signal

no_signal

Daily use

phase 1 and 2 safety review

DSMB prep

faster internal risk calls

cleaner submission narratives

Next high-impact clinical dataset

ClarusC64/clinical-dose-selection-coherence-v0.1

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