Every reported adverse event triaged with an E2A clock; serious ones with a physician.
Escalates: Every serious or severe adverse event as a critical task; causality and expectedness are never decided by software
— to the safety physician.
Across 608 coded events in 123 treated patients, 5 new safety reports were triaged: all 5 are serious (grade 3–4), 4 with causality "suspected" and 1 "not_suspected" (Cholecystitis), and all 5 have opened review tasks with 0 already pending. All 5 ICH E2A expedited clocks are overdue, earliest due 2013-10-14 (Cholecystitis), followed by three Anaemia clocks (2013-11-01, 2013-11-06, 2013-11-14) and one Febrile neutropenia clock (2013-11-13). Disproportionality screening (Evans 2001: PRR ≥2.0, χ²≥4.0, ≥3 cases) flagged Anaemia (PRR 4.8, χ² 12164.1), Febrile neutropenia (PRR 36.86, χ² 284898.7), and Pyrexia (PRR 2.79, χ² 5037.0) among new signals, all marked unexpected per the doxorubicin label. The study has 1 study-total death (0 flagged this run). A human safety physician must decide causality and disposition for these 5 overdue serious events.
Across 608 coded events in 123 treated patients, 5 new safety reports were triaged: all 5 are serious (grade 3–4), 4 with causality "suspected" and 1 "not_suspected" (Cholecystitis), and all 5 have opened review tasks with 0 already pending. All 5 ICH E2A expedited clocks are overdue, earliest due 2013-10-14 (Cholecystitis), followed by three Anaemia clocks (2013-11-01, 2013-11-06, 2013-11-14) and one Febrile neutropenia clock (2013-11-13). Disproportionality screening (Evans 2001: PRR ≥2.0, χ²≥4.0, ≥3 cases) flagged Anaemia (PRR 4.8, χ² 12164.1), Febrile neutropenia (PRR 36.86, χ² 284898.7), and Pyrexia (PRR 2.79, χ² 5037.0) among new signals, all marked unexpected per the doxorubicin label. The study has 1 study-total death (0 flagged this run). A human safety physician must decide causality and disposition for these 5 overdue serious events.
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 — aggregate=%{"coded_events" => 608, "deaths" => 1, "event
Evidence
Deterministic summary
Triaged 5 new report(s): 5 under physician review (5 serious, 0 with no causality assessment), 0 auto-assessed; 5 review task(s) opened (5 critical SAE tasks), 0 already pending. 5 expedited clock(s) (ICH E2A), earliest due 2013-10-14, 5 OVERDUE. Signal review over 608 events in 123 treated patients (per arm): most frequent term Anaemia (49 patients, 39.8%); 6 FAERS disproportionality flag(s) for the doxorubicin (anthracycline) class (screening only), 4 potential new signal(s) off-label with ≥3 serious cases. Causality is never decided by software; serious events stay open until the safety physician decides.
Reported
5
Aggregate
Coded events
608
Deaths
1
Events
608
Patients treated
123
Patients with events
111
Pooled only
no
Pooling note
Incidence shown per arm (study open-label).
Serious events
80
New signals
Expected
Serious events
Serious patients
Term
no
9
9
Anaemia
no
16
16
Febrile neutropenia
no
3
3
Pyrexia
no
3
3
Cellulitis
Per arm
Arm
Terms
Treated
Aldoxorubicin (INNO-206) 350 mg/m2
Incidence
Patients
Term
0.43
36
Anaemia
0.46
38
Nausea
0.40
33
Neutropenia
0.30
25
Alopecia
0.34
28
Stomatitis
0.29
24
Fatigue
0.23
19
Vomiting
0.24
20
Decreased appetite
0.16
13
Febrile neutropenia
0.18
15
Asthenia
83
Doxorubicin 75 mg/m2
Incidence
Patients
Term
0.33
13
Anaemia
0.28
11
Nausea
0.18
7
Neutropenia
0.30
12
Alopecia
0.13
5
Stomatitis
0.15
6
Fatigue
0.18
7
Vomiting
0.05
2
Decreased appetite
0.18
7
Febrile neutropenia
0.13
5
Asthenia
40
Top terms
Events
Expected
Incidence
Max grade
Patients
Serious events
Serious patients
Term
58
no
0.40
4
49
9
9
Anaemia
49
yes
0.40
3
49
0
0
Nausea
41
yes
0.33
4
40
1
1
Neutropenia
37
yes
0.30
2
37
0
0
Alopecia
36
yes
0.27
3
33
3
3
Stomatitis
30
no
0.24
3
30
0
0
Fatigue
29
yes
0.21
3
26
3
3
Vomiting
22
no
0.18
3
22
0
0
Decreased appetite
36
no
0.16
4
20
16
16
Febrile neutropenia
20
yes
0.16
3
20
0
0
Asthenia
Causality
Not suspected
1
Suspected
4
Unassessed
0
Citations
Label
Url
ICH E2A (1994) Clinical Safety Data Management: Definitions and Standards for Expedited Reporting — 7-day fatal/life-threatening and 15-day serious unexpected clocks
FAERS is spontaneous reporting without an exposure denominator; disproportionality is a screening signal only, not an incidence or a causal finding.
Class total reports
95402
Comparator
FAERS reports for doxorubicin (anthracycline) (95402 reports) vs all-drug FAERS background (20692690 reports)
Method
PRR = (a/(a+b)) / (c/(c+d)); flag when PRR ≥ 2.0, χ² ≥ 4.0 and ≥ 3 study cases (Evans 2001)
Flagged
Chi2
Prr
Study events
Term
12164.10
4.80
58
Anaemia
60445.10
11.37
41
Neutropenia
4244.90
3.19
37
Alopecia
284898.70
36.86
36
Febrile neutropenia
24103.90
8.12
21
Thrombocytopenia
5037.00
2.79
20
Pyrexia
Table
Chi2
Faers background reports
Faers class reports
Faers class share
Flagged
Note
Prr
Study events
Study incidence
Study patients
Term
12164.10
184242
4096
0.04
yes
—
4.80
58
0.40
49
Anaemia
0.10
774977
3569
0.04
no
—
0.99
49
0.40
49
Nausea
60445.10
127026
6687
0.07
yes
—
11.37
41
0.33
40
Neutropenia
4244.90
191346
2831
0.03
yes
—
3.19
37
0.30
37
Alopecia
248730.60
0
1152
0.01
no
term outside the all-drug top-200 FAERS reaction list — no background comparator
—
36
0.27
33
Stomatitis
276.20
764028
2567
0.03
no
—
0.73
30
0.24
30
Fatigue
267.30
459785
2878
0.03
no
—
1.35
29
0.21
26
Vomiting
31.30
227336
1234
0.01
no
—
1.17
22
0.18
22
Decreased appetite
284898.70
55818
9530
0.10
yes
—
36.86
36
0.16
20
Febrile neutropenia
0.60
369418
1678
0.02
no
—
0.98
20
0.16
20
Asthenia
398802.80
0
1847
0.02
no
term outside the all-drug top-200 FAERS reaction list — no background comparator
—
22
0.15
19
Leukopenia
24103.90
106057
3987
0.04
yes
—
8.12
21
0.15
18
Thrombocytopenia
5037.00
337277
4362
0.05
yes
—
2.79
20
0.14
17
Pyrexia
—
0
0
0.00
no
term outside the class' top-100 FAERS reaction list — PRR not computable from the snapshot
—
3
0.02
3
Cellulitis
Drug class
Expectedness source
US label DOXORUBICIN HYDROCHLORIDE (openFDA, effective 20260430), 33 listed terms
Key
doxorubicin
Name
doxorubicin (anthracycline)
Proxy note
Aldoxorubicin is investigational; the doxorubicin hydrochloride US label is the reference for expectedness, and FAERS reports naming doxorubicin the comparator.
Snapshot fetched at
2026-09-19T08:07:13Z
Expectedness
Expected
0
Undetermined
0
Unexpected
5
Expedited
Clock rule
ICH E2A: 7 days fatal/life-threatening unexpected, 15 days other serious unexpected; existing earlier deadlines kept
This is a pooled safety review across 307 treated patients with 1043 events (98 serious, 0 deaths), since the study is blinded and per-arm rates are not computed. The most frequent term is Nausea, 109 patients (35.5% incidence), followed by Alopecia (85 patients, 27.69%) and Neutropenia (83 patients, 27.04%).
Using FAERS disproportionality screening (Evans 2001: PRR ≥2.0, χ² ≥4.0, ≥3 cases) against the anti-PD-1 class comparator, 5 terms flagged: Neutropenia (PRR 2.64, χ² 3994.5), Anaemia (PRR 2.56, χ² 5134.6), Thrombocytopenia (PRR 3.02, χ² 4916.7), Peripheral neuropathy (PRR 3.01, χ² 4162.6), and Decreased appetite (PRR 2.78, χ² 8092.3). These are screening signals only, not causal findings. No new signals were identified (0 off-label with ≥3 serious cases). There are 11 overdue expedited-reporting clocks (e.g., Diarrhoea due 2026-09-04, Neutropenia due 2026-09-16). A human reviewer should decide how to address the overdue expedited-reporting clocks and assess causality for serious events.
This is a pooled safety review across 307 treated patients with 1043 events (98 serious, 0 deaths), since the study is blinded and per-arm rates are not computed. The most frequent term is Nausea, 109 patients (35.5% incidence), followed by Alopecia (85 patients, 27.69%) and Neutropenia (83 patients, 27.04%).
Using FAERS disproportionality screening (Evans 2001: PRR ≥2.0, χ² ≥4.0, ≥3 cases) against the anti-PD-1 class comparator, 5 terms flagged: Neutropenia (PRR 2.64, χ² 3994.5), Anaemia (PRR 2.56, χ² 5134.6), Thrombocytopenia (PRR 3.02, χ² 4916.7), Peripheral neuropathy (PRR 3.01, χ² 4162.6), and Decreased appetite (PRR 2.78, χ² 8092.3). These are screening signals only, not causal findings. No new signals were identified (0 off-label with ≥3 serious cases). There are 11 overdue expedited-reporting clocks (e.g., Diarrhoea due 2026-09-04, Neutropenia due 2026-09-16). A human reviewer should decide how to address the overdue expedited-reporting clocks and assess causality for serious events.
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 — aggregate=%{"coded_events" => 1041, "deaths" => 0, "events" => 1043, "new_signals" => [], "patients_treated" => 307, "patients_wit
Evidence
Deterministic summary
0 new reports to triage (13 awaiting physician review). No expedited clock running on this batch. Signal review over 1043 events in 307 treated patients (pooled — study blinded): most frequent term Nausea (109 patients, 35.5%); 5 FAERS disproportionality flag(s) for the anti-PD-1 (programmed death receptor-1 blocking antibody) class (screening only), 0 potential new signal(s) off-label with ≥3 serious cases. Causality is never decided by software; serious events stay open until the safety physician decides.
Reported
0
Aggregate
Coded events
1041
Deaths
0
Events
1043
Patients treated
307
Patients with events
260
Pooled only
yes
Pooling note
Study is blinded and active: incidence pooled across arms only; per-arm rates are not computed until unblinding.
Serious events
98
New signals
none
Per arm
none
Top terms
Events
Expected
Incidence
Max grade
Patients
Serious events
Serious patients
Term
143
yes
0.36
4
109
18
16
Nausea
102
yes
0.28
4
85
9
9
Alopecia
108
yes
0.27
4
83
14
12
Neutropenia
102
yes
0.26
4
81
8
8
Anaemia
89
yes
0.26
4
80
9
9
Thrombocytopenia
56
yes
0.17
4
51
6
6
Asthenia
59
yes
0.16
3
50
1
1
Peripheral neuropathy
51
yes
0.16
4
50
4
4
Fatigue
52
yes
0.15
3
47
5
5
Diarrhoea
49
yes
0.15
4
46
5
5
Decreased appetite
Causality
Not suspected
0
Suspected
0
Unassessed
0
Citations
Label
Url
ICH E2A (1994) Clinical Safety Data Management: Definitions and Standards for Expedited Reporting — 7-day fatal/life-threatening and 15-day serious unexpected clocks
This run triaged 11 new reports, all serious and all sent to physician review (5 with unassessed causality), with 11 SAE review tasks opened and 0 already pending. Study totals stand at 1043 events across 307 treated patients, pooled only (blinded study), with 260 patients affected, 98 serious events, and 0 deaths. Top term is Nausea (109 patients, 35.5% incidence, 18 serious events). Per ICH E2A expedited clocks, 11 clocks are open (earliest due 2026-09-04), with 4 marked overdue (Diarrhoea, Asthenia, Neutropenia, Fatigue). FAERS disproportionality screening (Evans 2001 criteria: PRR ≥2.0, χ²≥4.0, ≥3 cases) flagged 5 terms versus the anti-PD-1 class background (239,888 reports vs 20,692,690 background): Neutropenia (PRR 2.64, χ² 3994.5), Anaemia (2.56, 5134.6), Thrombocytopenia (3.02, 4916.7), Peripheral neuropathy (3.01, 4162.6), Decreased appetite (2.78, 8092.3) — screening only, no new signals. A human reviewer must decide causality and disposition for the 11 opened SAE tasks, including the 4 overdue expedited-reporting clocks.
This run triaged 11 new reports, all serious and all sent to physician review (5 with unassessed causality), with 11 SAE review tasks opened and 0 already pending. Study totals stand at 1043 events across 307 treated patients, pooled only (blinded study), with 260 patients affected, 98 serious events, and 0 deaths. Top term is Nausea (109 patients, 35.5% incidence, 18 serious events). Per ICH E2A expedited clocks, 11 clocks are open (earliest due 2026-09-04), with 4 marked overdue (Diarrhoea, Asthenia, Neutropenia, Fatigue). FAERS disproportionality screening (Evans 2001 criteria: PRR ≥2.0, χ²≥4.0, ≥3 cases) flagged 5 terms versus the anti-PD-1 class background (239,888 reports vs 20,692,690 background): Neutropenia (PRR 2.64, χ² 3994.5), Anaemia (2.56, 5134.6), Thrombocytopenia (3.02, 4916.7), Peripheral neuropathy (3.01, 4162.6), Decreased appetite (2.78, 8092.3) — screening only, no new signals. A human reviewer must decide causality and disposition for the 11 opened SAE tasks, including the 4 overdue expedited-reporting clocks.
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 — aggregate=%{"coded_events" => 1041, "deaths" => 0, "events" => 1043, "new_signals" => [], "patients_treated" => 307, "patients_wit
Evidence
Deterministic summary
Triaged 11 new report(s): 11 under physician review (11 serious, 5 with no causality assessment), 0 auto-assessed; 11 review task(s) opened (11 critical SAE tasks), 0 already pending. 11 expedited clock(s) (ICH E2A), earliest due 2026-09-04, 4 OVERDUE. Signal review over 1043 events in 307 treated patients (pooled — study blinded): most frequent term Nausea (109 patients, 35.5%); 5 FAERS disproportionality flag(s) for the anti-PD-1 (programmed death receptor-1 blocking antibody) class (screening only), 0 potential new signal(s) off-label with ≥3 serious cases. Causality is never decided by software; serious events stay open until the safety physician decides.
Reported
11
Aggregate
Coded events
1041
Deaths
0
Events
1043
Patients treated
307
Patients with events
260
Pooled only
yes
Pooling note
Study is blinded and active: incidence pooled across arms only; per-arm rates are not computed until unblinding.
Serious events
98
New signals
none
Per arm
none
Top terms
Events
Expected
Incidence
Max grade
Patients
Serious events
Serious patients
Term
143
yes
0.36
4
109
18
16
Nausea
102
yes
0.28
4
85
9
9
Alopecia
108
yes
0.27
4
83
14
12
Neutropenia
102
yes
0.26
4
81
8
8
Anaemia
89
yes
0.26
4
80
9
9
Thrombocytopenia
56
yes
0.17
4
51
6
6
Asthenia
59
yes
0.16
3
50
1
1
Peripheral neuropathy
51
yes
0.16
4
50
4
4
Fatigue
52
yes
0.15
3
47
5
5
Diarrhoea
49
yes
0.15
4
46
5
5
Decreased appetite
Causality
Not suspected
4
Suspected
2
Unassessed
5
Citations
Label
Url
ICH E2A (1994) Clinical Safety Data Management: Definitions and Standards for Expedited Reporting — 7-day fatal/life-threatening and 15-day serious unexpected clocks