Active patients scored; at-risk cohort proposed for outreach.
Escalates: Participants above the dropout-risk threshold, with proposed outreach a coordinator approves before anyone is contacted
— to the study coordinator.
This is a retrospective review of a completed study (INNO-206 vs Doxorubicin, soft-tissue sarcoma, Phase II), with 0 active patients and 0 patients scored, so no live dropout risk scoring applies. Among 126 ever-consented subjects, 20 withdrew, giving a withdrawal density of 15.9%, which is below the 25% red-flag threshold cited in docs/intent/lit_review_synthesis.md (heuristic proxy, no validated cutoff); accordingly withdrawal_density_flag is false. Median time to withdrawal was 60.5 days. Top disposition reasons were WITHDRAWAL BY SUBJECT (9), PROTOCOL VIOLATION (6), OTHER (3), and PHYSICIAN DECISION (2). Cited literature (Dombernowsky et al. 2019, Trials 20:708; Zhang & DuBois 2023, Cancer Med 12:5517) notes retention/staffing issues can compound accrual-driven termination risk, but no such escalation is indicated here. No review was opened (review_opened: false), so no human decision is required at this time.
This is a retrospective review of a completed study (INNO-206 vs Doxorubicin, soft-tissue sarcoma, Phase II), with 0 active patients and 0 patients scored, so no live dropout risk scoring applies. Among 126 ever-consented subjects, 20 withdrew, giving a withdrawal density of 15.9%, which is below the 25% red-flag threshold cited in docs/intent/lit_review_synthesis.md (heuristic proxy, no validated cutoff); accordingly withdrawal_density_flag is false. Median time to withdrawal was 60.5 days. Top disposition reasons were WITHDRAWAL BY SUBJECT (9), PROTOCOL VIOLATION (6), OTHER (3), and PHYSICIAN DECISION (2). Cited literature (Dombernowsky et al. 2019, Trials 20:708; Zhang & DuBois 2023, Cancer Med 12:5517) notes retention/staffing issues can compound accrual-driven termination risk, but no such escalation is indicated here. No review was opened (review_opened: false), so no human decision is required at this time.
Input: A Multicenter, Randomized, Open-Label Phase 2b Study to Investigate the Preliminary Efficacy and Safety of INNO-206 (Doxorubicin-EMCH) Compared to Doxorubicin in Subjects With Metastatic, Locally Advanced, or Unresectable Soft Tissue Sarcoma — as_of="2014-12-15", at_risk=0, branch="retrospective", c
Evidence
As of
2014-12-15
At risk
0
Branch
retrospective
Deterministic summary
No active patients on this completed study; retrospective over 126 ever-consented: withdrawal density 15.9% (20 withdrawn), median time to withdrawal 61 d; top reasons: WITHDRAWAL BY SUBJECT (9), PROTOCOL VIOLATION (6), OTHER (3), PHYSICIAN DECISION (2).
Patients scored
0
Review opened
no
Study status
completed
Citations
Dombernowsky et al. 2019, Trials 20:708 — thin site staffing and overestimated pools drive conduct risk; site-level withdrawal rate used as a prior.
docs/intent/lit_review_synthesis.md — withdrawal density ≥ 25% of ever-consented is the retention red flag (heuristic proxy, no validated cutoff).
NxtCure predictive-retention synthesis — retention signals feed a score; outreach is proposed to humans, never sent autonomously.
Zhang & DuBois 2023, Cancer Med 12:5517 — retention failure compounds accrual-driven early termination (34.5% of terminations).
This run scored 269 active patients with a heuristic logistic model (coefficients are priors, not fitted to this study). Since fewer than 5 patients reached p≥0.5, the selection rule fell back to the top decile, flagging 27 patients as at elevated dropout risk. The highest-risk patient, SITE013-0226, has p=0.472, driven by 1 grade ≥3 AE, 1 serious AE in the last 60 days, and treatment stopped 40 days ago. Cohort-wide withdrawal density is 1.6% (5/317), well below the 0.25 heuristic red-flag threshold from docs/intent/lit_review_synthesis.md, so the withdrawal_density_flag is false. Per Zhang & DuBois 2023 (Cancer Med 12:5517), retention failure contributes to 34.5% of terminations, underscoring why this monitoring matters. The review task is already pending (review_opened: false, status "already_pending"). The human reviewer is asked to decide whether outreach should be initiated for the 27 flagged patients, particularly the top-ranked SITE013 cases.
This run scored 269 active patients with a heuristic logistic model (coefficients are priors, not fitted to this study). Since fewer than 5 patients reached p≥0.5, the selection rule fell back to the top decile, flagging 27 patients as at elevated dropout risk. The highest-risk patient, SITE013-0226, has p=0.472, driven by 1 grade ≥3 AE, 1 serious AE in the last 60 days, and treatment stopped 40 days ago. Cohort-wide withdrawal density is 1.6% (5/317), well below the 0.25 heuristic red-flag threshold from docs/intent/lit_review_synthesis.md, so the withdrawal_density_flag is false. Per Zhang & DuBois 2023 (Cancer Med 12:5517), retention failure contributes to 34.5% of terminations, underscoring why this monitoring matters. The review task is already pending (review_opened: false, status "already_pending"). The human reviewer is asked to decide whether outreach should be initiated for the 27 flagged patients, particularly the top-ranked SITE013 cases.
Input: A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer — as_of="2026-09-19", at_risk=27, citations=["Dombernowsky et al. 2019, Trials 20:708 — thin site staffing and overestimated pools d
Evidence
As of
2026-09-19
At risk
27
Deterministic summary
Scored 269 active patient(s) with a heuristic logistic model; 27 at elevated dropout risk (p ≥ 0.5 or top decile, since fewer than 5 reached the threshold). Highest risk SITE013-0226 p=0.472: 1 grade ≥3 AE(s); 1 serious AE(s) in last 60 d; treatment stopped 40 d ago; site withdrawal rate 4.3%. Cohort withdrawal density 1.6% (5/317). Outreach task already pending; roster refreshed on this run.
Luna linked
4
Patients scored
269
Review opened
no
Review task
already_pending
Selection rule
p>=0.5 or top decile (with at least one patient-level signal)
Threshold
0.50
Citations
Dombernowsky et al. 2019, Trials 20:708 — thin site staffing and overestimated pools drive conduct risk; site-level withdrawal rate used as a prior.
docs/intent/lit_review_synthesis.md — withdrawal density ≥ 25% of ever-consented is the retention red flag (heuristic proxy, no validated cutoff).
NxtCure predictive-retention synthesis — retention signals feed a score; outreach is proposed to humans, never sent autonomously.
Zhang & DuBois 2023, Cancer Med 12:5517 — retention failure compounds accrual-driven early termination (34.5% of terminations).
Cohort
Active
269
As of
2026-09-19
Ever consented
317
Withdrawal density
0.02
Withdrawal density flag
no
Withdrawal density threshold
0.25
Withdrawn
5
Status counts
Completed
43
Enrolled
269
Withdrawn
5
Distribution
Max
0.47
Mean
0.13
P10
0.08
P50
0.08
P90
0.27
Model
Form
p = 1 / (1 + exp(-(b0 + sum(bi * xi))))
Note
Coefficients are heuristic priors from the retention literature, not fitted to this study's outcomes.
The retention model scored 269 active patients using a heuristic logistic function (coefficients described as "heuristic priors from the retention literature, not fitted to this study's outcomes"). Since no patient reached the 0.5 threshold, the top decile was used per the selection rule "p>=0.5 or top decile (with at least one patient-level signal)," flagging 27 patients as at elevated dropout risk. Highest risk is SITE013-0226 at p=0.472, driven by 1 grade ≥3 AE, 1 serious AE in the last 60 days, and treatment stopped 40 days ago. Cohort-level withdrawal density is 1.6% (5/317), well below the 0.25 red-flag threshold from the lit-review heuristic, so withdrawal_density_flag is false. Citations reference Dombernowsky et al. 2019 and Zhang & DuBois 2023 on retention/accrual risk. A review task was opened; the human is asked to decide whether to approve proactive outreach to the flagged patients.
The retention model scored 269 active patients using a heuristic logistic function (coefficients described as "heuristic priors from the retention literature, not fitted to this study's outcomes"). Since no patient reached the 0.5 threshold, the top decile was used per the selection rule "p>=0.5 or top decile (with at least one patient-level signal)," flagging 27 patients as at elevated dropout risk. Highest risk is SITE013-0226 at p=0.472, driven by 1 grade ≥3 AE, 1 serious AE in the last 60 days, and treatment stopped 40 days ago. Cohort-level withdrawal density is 1.6% (5/317), well below the 0.25 red-flag threshold from the lit-review heuristic, so withdrawal_density_flag is false. Citations reference Dombernowsky et al. 2019 and Zhang & DuBois 2023 on retention/accrual risk. A review task was opened; the human is asked to decide whether to approve proactive outreach to the flagged patients.
Input: A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer — as_of="2026-09-19", at_risk=27, citations=["Dombernowsky et al. 2019, Trials 20:708 — thin site staffing and overestimated pools d
Evidence
As of
2026-09-19
At risk
27
Deterministic summary
Scored 269 active patient(s) with a heuristic logistic model; 27 at elevated dropout risk (p ≥ 0.5 or top decile, since fewer than 5 reached the threshold). Highest risk SITE013-0226 p=0.472: 1 grade ≥3 AE(s); 1 serious AE(s) in last 60 d; treatment stopped 40 d ago; site withdrawal rate 4.3%. Cohort withdrawal density 1.6% (5/317). Proactive outreach proposed for human approval — patient contact is never autonomous.
Luna linked
4
Patients scored
269
Review opened
yes
Review task
opened
Selection rule
p>=0.5 or top decile (with at least one patient-level signal)
Threshold
0.50
Citations
Dombernowsky et al. 2019, Trials 20:708 — thin site staffing and overestimated pools drive conduct risk; site-level withdrawal rate used as a prior.
docs/intent/lit_review_synthesis.md — withdrawal density ≥ 25% of ever-consented is the retention red flag (heuristic proxy, no validated cutoff).
NxtCure predictive-retention synthesis — retention signals feed a score; outreach is proposed to humans, never sent autonomously.
Zhang & DuBois 2023, Cancer Med 12:5517 — retention failure compounds accrual-driven early termination (34.5% of terminations).
Cohort
Active
269
As of
2026-09-19
Ever consented
317
Withdrawal density
0.02
Withdrawal density flag
no
Withdrawal density threshold
0.25
Withdrawn
5
Status counts
Completed
43
Enrolled
269
Withdrawn
5
Distribution
Max
0.47
Mean
0.13
P10
0.08
P50
0.08
P90
0.27
Model
Form
p = 1 / (1 + exp(-(b0 + sum(bi * xi))))
Note
Coefficients are heuristic priors from the retention literature, not fitted to this study's outcomes.