← PV Literature Screening — Z:II:X Capital

Sample screening record — daridorexant (Quviviq)

Protocol: ZIIX-PV-LS-001 v1.0 Run id: PVLS-ZIIX-PV-LS-001-20261031T111302Z Retrieved (UTC): 2026-10-31T11:13:07Z Window: 2023/11/01 → 2026/10/31 (36 months) Source: NCBI PubMed E-utilities — esearch.fcgi + efetch.fcgi, db=pubmed, retmode=json / xml, sort=date

This is a real run over public literature. It is a demonstration of the screening protocol, not client data.

Search string, as executed

("daridorexant"[Title/Abstract]) AND (adverse[tiab] OR safety[tiab] OR "side effect"[tiab] OR "adverse event"[tiab]) AND ("2023/11/01"[Date - Publication] : "2026/10/31"[Date - Publication])

esearch reported 60 records; 60 were retrieved and screened. No record was dropped without a recorded reason.

Result

	Count
Retrieved and screened	60
Included (case candidates flagged)	23
Excluded	37

Exclusions by reason

Code	Reason	n
X2	X2 — NO_NEW_CASES: a review, editorial, comment, guideline or meta-analysis carrying no new case data.	20
X3	X3 — NO_SAFETY_DATA: the record reports no adverse event, tolerability or safety outcome.	1
X4	X4 — DRUG_NOT_IMPLICATED: the medicine is mentioned, but no reported adverse event is attributed to it.	14
X6	X6 — STUDY_PROTOCOL: a study protocol or design paper reporting no results; it can contain no case.	2

Completeness check: included + excluded = 23 + 37 = 60 vs retrieved 60 → every retrieved record has a decision.

Flagged case candidates

PMID 42888253 — Sun D, Li J, Chen G, Liu X, Jiang C, Ye T. Suicidal ideation associated with daridorexant treatment in insomnia patients: Comparator-restricted disproportionality analysis and assessment of potential heterogeneity in reporting patterns.. Social psychiatry and psychiatric epidemiology. 2026:10.1007/s00127-026-03227-9. doi:10.1016/j.jclinepi.2023.08.010 PMID:42888253.

Why flagged: INCLUDE — INCLUDED: human record in which the medicine is implicated in a reported adverse event, tolerability or safety finding.
Basis: "Suicidal ideation associated with daridorexant treatment in insomnia patients: Comparator-restricted disproportionality analysis and assessment of potential heterogeneity in reporting patterns." "Although previous studies have identified a significant signal for suicidal ideation associated with daridorexant when compared with all other drugs, the significance when compared specifically with insomnia medications and the potential differences in reporting patterns of suicidal ideation across subgroups remain unclear."
Source: <https://pubmed.ncbi.nlm.nih.gov/42888253/>

PMID 42674807 — Svedmyr S, Bergqvist J. Daridorexant- Case Report of Possible Side-Effect in Rare Mitochondrial Disorder.. Journal of sleep research. 2026:e70440. doi:10.1111/jsr.70440 PMID:42674807.

Why flagged: INCLUDE — INCLUDED: human record in which the medicine is implicated in a reported adverse event, tolerability or safety finding.
Basis: "Daridorexant- Case Report of Possible Side-Effect in Rare Mitochondrial Disorder."
Source: <https://pubmed.ncbi.nlm.nih.gov/42674807/>

PMID 42171662 — Fietze I, Boof ML, Lederer K, Lemoine V, Vaillant C, Pépin JL. Daridorexant in severe obstructive sleep apnea: effects on sleep-disordered breathing and sleep.. Sleep. 2026;49(9):zsag145. doi:10.5664/jcsm.9300 PMID:42171662.

Why flagged: INCLUDE — INCLUDED: human record in which the medicine is implicated in a reported adverse event, tolerability or safety finding.
Basis: "Four adverse events were reported (daridorexant n = 3;"
Source: <https://pubmed.ncbi.nlm.nih.gov/42171662/>

PMID 41506007 — Schaedel Z, Bakker TR, Bassetti C, Briasoulis O, Cassel P, Pain S, et al. Efficacy and safety of daridorexant for the treatment of insomnia disorder in women of menopausal transition age: Insights from a randomized controlled trial.. Maturitas. 2026;206:108821. doi:10.1016/j.maturitas.2025.108821 PMID:41506007.

Why flagged: INCLUDE — INCLUDED: human record in which the medicine is implicated in a reported adverse event, tolerability or safety finding.
Basis: "Efficacy and safety of daridorexant for the treatment of insomnia disorder in women of menopausal transition age: Insights from a randomized controlled trial." "OBJECTIVES: To evaluate the efficacy and safety of daridorexant in women aged 47-55 years with insomnia disorder, an age group representative of the menopause transition."
Source: <https://pubmed.ncbi.nlm.nih.gov/41506007/>

PMID 41262489 — Kono S, Nishiyama T, Nakano S, Ishimoto Y, Horikoshi S. Real-World Effectiveness and Safety of Daridorexant in Japanese Patients With Insomnia: A Multicenter Observational Study Evaluating Four-Week Changes in Athens Insomnia Scale Among 54 Participants.. Cureus. 2025;17(11):e97174. doi:10.7759/cureus.97174 PMID:41262489.

Why flagged: INCLUDE — INCLUDED: human record in which the medicine is implicated in a reported adverse event, tolerability or safety finding.
Basis: "Real-World Effectiveness and Safety of Daridorexant in Japanese Patients With Insomnia: A Multicenter Observational Study Evaluating Four-Week Changes in Athens Insomnia Scale Among 54 Participants." "Therefore, this observational study assessed the effectiveness and safety of daridorexant in real-world settings for Japanese participants with insomnia beyond those evaluated in previous clinical trials."
Source: <https://pubmed.ncbi.nlm.nih.gov/41262489/>

PMID 41217192 — Pathmanathan J, Little D, Sadeghi K, Di Marco T, Kleinschmidt D, Nerrie J, et al. The Insomnia EEG Score: a new tool for the classification of people with poor sleep.. Sleep. 2026;49(4):zsaf353. doi:10.1093/sleep/zsaf353 PMID:41217192.

Why flagged: INCLUDE — INCLUDED: human record in which the medicine is implicated in a reported adverse event, tolerability or safety finding.
Basis: "Clinical Trials Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects with Insomnia Disorder, https://clinicaltrials.gov/study/NCT03545191, NCT03545191;" "Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering from Difficulties to Sleep, https://www.clinicaltrials.gov/study/NCT03575104, NCT03575104."
Source: <https://pubmed.ncbi.nlm.nih.gov/41217192/>

PMID 40776640 — Ferini-Strambi L, Arnaldi D, Bonanni E, Cicolin A, Gigli GL, Liguori C, et al. Daridorexant and Insomnia in Clinical Practice: A Nominal Group Technique Consensus Study among Italian Sleep and Insomnia Experts.. Current neuropharmacology. 2026;24(1):135-149. doi:10.1016/j.smrv.2023.101762 PMID:40776640.

Why flagged: INCLUDE — INCLUDED: human record in which the medicine is implicated in a reported adverse event, tolerability or safety finding.
Basis: "Key findings highlight daridorexant's mechanism of action, safety profile, efficacy on night and day parameters, and suitability for long-term use." "DISCUSSION: Daridorexant may address insomnia without increasing sedation via its dual orexin receptor antagonism."
Source: <https://pubmed.ncbi.nlm.nih.gov/40776640/>

PMID 40660750 — Lettieri CJ, Briasoulis O, Léger D, Luyet PP, Pépin JL, Quan SF, et al. The Effects of Daridorexant on Patients With Comorbid Insomnia Disorder and Untreated Mild Obstructive Sleep Apnoea: A Post Hoc Subgroup Analysis of a Phase 3, Randomised Clinical Trial.. Journal of sleep research. 2026;35(2):e70135. doi:10.5664/jcsm.7112 PMID:40660750.

Why flagged: INCLUDE — INCLUDED: human record in which the medicine is implicated in a reported adverse event, tolerability or safety finding.
Basis: "This post hoc analysis evaluated the efficacy and safety of daridorexant 25 and 50 mg on objective and self-reported insomnia variables and self-reported daytime functioning in patients with untreated mild OSA and comorbid insomnia disorder (COMISA)." "No safety concerns were reported for daridorexant 50 or 25 mg."
Source: <https://pubmed.ncbi.nlm.nih.gov/40660750/>

PMID 40557879 — Huang Z, Wang H, Zhang B, Li C, Wang J, Xu L, et al. Efficacy and safety of daridorexant in Chinese patients with insomnia disorder: a multicenter, randomized, double-blind, placebo-controlled phase III clinical trial.. Sleep. 2025;48(12):zsaf170. doi:10.1093/sleep/zsaf170 PMID:40557879.

Why flagged: INCLUDE — INCLUDED: human record in which the medicine is implicated in a reported adverse event, tolerability or safety finding.
Basis: "Efficacy and safety of daridorexant in Chinese patients with insomnia disorder: a multicenter, randomized, double-blind, placebo-controlled phase III clinical trial." "STUDY OBJECTIVES: To evaluate the efficacy and safety of daridorexant in Chinese patients with insomnia disorder."
Source: <https://pubmed.ncbi.nlm.nih.gov/40557879/>

PMID 40083090 — Lederer K, Benes H, Fine A, Shoffner S, Bacchelli S, Diaz DC, et al. A randomised crossover trial of daridorexant for the treatment of chronic insomnia and nocturia.. Journal of sleep research. 2025;34(6):e70002. doi:10.1111/jsr.70002 PMID:40083090.

Why flagged: INCLUDE — INCLUDED: human record in which the medicine is implicated in a reported adverse event, tolerability or safety finding.
Basis: "This double-blind, placebo-controlled, two-way crossover trial evaluated the efficacy and safety of daridorexant in patients with chronic insomnia and comorbid nocturia." "No adverse events of special interest (falls/urinary incontinence) were reported during daridorexant treatment."
Source: <https://pubmed.ncbi.nlm.nih.gov/40083090/>

PMID 39985333 — Sun Y, Xu T, Xu H. Safety of dual orexin receptor antagonists: a real-world pharmacovigilance study.. Expert opinion on drug safety. 2026;25(9):1695-1701. doi:10.1080/14740338.2025.2471520 PMID:39985333.

Why flagged: INCLUDE — INCLUDED: human record in which the medicine is implicated in a reported adverse event, tolerability or safety finding.
Basis: "METHODS: Data related to daridorexant, suvorexant, and lemborexant were collected from the US Food and Drug Administration Adverse Event Reporting System between the first quarter of 2022 and the third quarter of 2024." "The highest signal of strength of PT was sleep paralysis for daridorexant and lemborexant, and abnormal sleep-related event for suvorexant."
Source: <https://pubmed.ncbi.nlm.nih.gov/39985333/>

PMID 39641404 — Magliocca M, Koopmans I, Vaillant C, Lemoine V, Zuiker R, Dingemanse J, et al. Nighttime safety of daridorexant: Evaluation of responsiveness to an external noise stimulus, postural stability, walking, and cognitive function.. Journal of psychopharmacology (Oxford, England). 2025;39(3):223-232. doi:10.1093/sleep/zsx086 PMID:39641404.

Why flagged: INCLUDE — INCLUDED: human record in which the medicine is implicated in a reported adverse event, tolerability or safety finding.
Basis: "Nighttime safety of daridorexant: Evaluation of responsiveness to an external noise stimulus, postural stability, walking, and cognitive function."
Source: <https://pubmed.ncbi.nlm.nih.gov/39641404/>

PMID 39166117 — Jiang M, Li H, Kong L. Data mining and safety analysis of dual orexin receptor antagonists (DORAs): a real-world pharmacovigilance study based on the FAERS database.. Frontiers in pharmacology. 2024;15:1436405. doi:10.3389/fphar.2021.766125 PMID:39166117.

Why flagged: INCLUDE — INCLUDED: human record in which the medicine is implicated in a reported adverse event, tolerability or safety finding.
Basis: "RESULTS: A total of 11,857 DORAs-related adverse reactions were detected, reported with suvorexant, lemborexant, and daridorexant as the main suspected drugs was 8717584, and 2556, respectively."
Source: <https://pubmed.ncbi.nlm.nih.gov/39166117/>

PMID 39128336 — Uchimura N, Ozone M, Suzuki M, Taniguchi M, Kuriyama K, Togo O, et al. Long-term safety and efficacy of daridorexant in Japanese patients with insomnia disorder.. Sleep medicine. 2024;122:64-70. doi:10.1016/j.sleep.2024.07.036 PMID:39128336.

Why flagged: INCLUDE — INCLUDED: human record in which the medicine is implicated in a reported adverse event, tolerability or safety finding.
Basis: "Long-term safety and efficacy of daridorexant in Japanese patients with insomnia disorder." "OBJECTIVE/BACKGROUND: The short-term efficacy and safety of daridorexant, a dual orexin receptor antagonist, has been demonstrated in Japanese patients with insomnia disorder."
Source: <https://pubmed.ncbi.nlm.nih.gov/39128336/>

PMID 39118245 — Uchiyama M, Mishima K, Yagi T, Yoshihara T, Eto T, Muehlan C, et al. Pharmacokinetics, safety, and efficacy of daridorexant in Japanese subjects: Results from phase 1 and 2 studies.. Journal of sleep research. 2025;34(1):e14302. doi:10.1111/jsr.14302 PMID:39118245.

Why flagged: INCLUDE — INCLUDED: human record in which the medicine is implicated in a reported adverse event, tolerability or safety finding.
Basis: "Pharmacokinetics, safety, and efficacy of daridorexant in Japanese subjects: Results from phase 1 and 2 studies."
Source: <https://pubmed.ncbi.nlm.nih.gov/39118245/>

PMID 39116704 — Uchimura N, Taniguchi M, Ariyoshi Y, Oka Y, Togo O, Uchiyama M. Daridorexant in Japanese patients with insomnia disorder: A phase 3, randomized, double-blind, placebo-controlled study.. Sleep medicine. 2024;122:27-34. doi:10.1016/j.sleep.2024.07.037 PMID:39116704.

Why flagged: INCLUDE — INCLUDED: human record in which the medicine is implicated in a reported adverse event, tolerability or safety finding.
Basis: "OBJECTIVE: This Phase 3 double-blind, placebo-controlled study evaluated the efficacy and safety of daridorexant in Japanese patients with insomnia disorder." "PATIENTS/METHODS: 490 patients with insomnia disorder from 95 sites in Japan were randomized to daridorexant 50 mg (n = 163), 25 mg (n = 163) or placebo (n = 164) for 4 weeks, followed by a 7-day placebo run-out and a 30-day safety follow-up."
Source: <https://pubmed.ncbi.nlm.nih.gov/39116704/>

PMID 39019232 — Wang Q, Zhou Q, Du Z, Lu R, Jiang Y, Zhu H. Clinical safety of daridorexant in insomnia treatment: Analysis of FDA adverse event reports.. Journal of affective disorders. 2024;362:552-559. doi:10.1016/j.jad.2024.07.034 PMID:39019232.

Why flagged: INCLUDE — INCLUDED: human record in which the medicine is implicated in a reported adverse event, tolerability or safety finding.
Basis: "Clinical safety of daridorexant in insomnia treatment: Analysis of FDA adverse event reports." "The aim of this study is to delve into the adverse events (AEs) of daridorexant by analyzing data from the FAERS database, to assess its safety and effectiveness in clinical applications."
Source: <https://pubmed.ncbi.nlm.nih.gov/39019232/>

PMID 38814132 — Chalet FX, Luyet PP, Rabasa C, Vaillant C, Saskin P, Ahuja A, et al. Daridorexant for patients with chronic insomnia disorder: number needed to treat, number needed to harm, and likelihood to be helped or harmed.. Postgraduate medicine. 2024;136(4):396-405. doi:10.1080/00325481.2024.2359891 PMID:38814132.

Why flagged: INCLUDE — INCLUDED: human record in which the medicine is implicated in a reported adverse event, tolerability or safety finding.
Basis: "Daridorexant for patients with chronic insomnia disorder: number needed to treat, number needed to harm, and likelihood to be helped or harmed." "OBJECTIVES: Appraise the evidence for daridorexant 50 mg and 25 mg versus placebo when treating chronic insomnia disorder in terms of number needed to treat (NNT), number needed to harm (NNH), and likelihood to be helped or harmed (LHH)."
Source: <https://pubmed.ncbi.nlm.nih.gov/38814132/>

PMID 38804896 — McIntyre RS, Wong S, Kwan ATH, Rhee TG, Teopiz KM, Ho R, et al. Association between dual orexin receptor antagonists (DORAs) and suicidality: reports to the United States Food and Drug Administration Adverse Event Reporting System (FAERS).. Expert opinion on drug safety. 2025;24(6):753-757. doi:10.1080/14740338.2024.2361300 PMID:38804896.

Why flagged: INCLUDE — INCLUDED: human record in which the medicine is implicated in a reported adverse event, tolerability or safety finding.
Basis: "BACKGROUND: Package inserts for the FDA-approved dual orexin receptor antagonists (DORAs) suvorexant, lemborexant and daridorexant state that suicide risk should be monitored."
Source: <https://pubmed.ncbi.nlm.nih.gov/38804896/>

PMID 38644625 — Di Marco T, Djonlagic I, Dauvilliers Y, Sadeghi K, Little D, Datta AN, et al. Effect of daridorexant on sleep architecture in patients with chronic insomnia disorder: a pooled post hoc analysis of two randomized phase 3 clinical studies.. Sleep. 2024;47(11):zsae098. doi:10.1016/j.ijpsycho.2021.07.626 PMID:38644625.

Why flagged: INCLUDE — INCLUDED: human record in which the medicine is implicated in a reported adverse event, tolerability or safety finding.
Basis: "CLINICAL TRIALS: ClinicalTrials.gov NCT03545191: study to assess the efficacy and safety of ACT-541468 (daridorexant) in adult and elderly participants with insomnia disorder." "URL: Study Details | study to assess the efficacy and safety of ACT-541468 (daridorexant) in adult and elderly participants with insomnia disorder | ClinicalTrials.gov ClinicalTrials.gov NCT03575104:study to assess the efficacy and safety of ACT-541468 (daridorexant) in adult and elderly participants who experience difficulties sleeping."
Source: <https://pubmed.ncbi.nlm.nih.gov/38644625/>

PMID 38622003 — Álamo C, Sáiz Ruiz J, Zaragozá Arnáez C. Orexinergic Receptor Antagonists as a New Therapeutic Target to Overcome Limitations of Current Pharmacological Treatment of Insomnia Disorder.. Actas espanolas de psiquiatria. 2024;52(2):172-182. doi:10.62641/aep.v52i2.1659 PMID:38622003.

Why flagged: INCLUDE — INCLUDED: human record in which the medicine is implicated in a reported adverse event, tolerability or safety finding.
Basis: "Dual orexin receptor antagonists (DORAs) such as daridorexant, lemborexant, and suvorexant, represent a novel approach to insomnia treatment by inhibiting wakefulness rather than enhancing sedation." "As the only DORA approved for insomnia treatment by the European Medicines Agency (EMA) and Food and Drug Administration (FDA), daridorexant has demonstrated sustained efficacy over a 12-month period, improving nocturnal sleep parameters and daytime functionality, with a favorable safety and tolerability profile."
Source: <https://pubmed.ncbi.nlm.nih.gov/38622003/>

PMID 38543128 — Cicala G, Barbieri MA, Russo G, Salvo F, Spina E. Safety of Dual Orexin Receptor Antagonist Daridorexant: A Disproportionality Analysis of Publicly Available FAERS Data.. Pharmaceuticals (Basel, Switzerland). 2024;17(3):342. doi:10.1007/s40801-021-00278-z PMID:38543128.

Why flagged: INCLUDE — INCLUDED: human record in which the medicine is implicated in a reported adverse event, tolerability or safety finding.
Basis: "Safety of Dual Orexin Receptor Antagonist Daridorexant: A Disproportionality Analysis of Publicly Available FAERS Data." "These data provide valuable insights into the real-world safety profile of daridorexant, supporting the existence of safety signals related to nightmares, depression, and hangovers."
Source: <https://pubmed.ncbi.nlm.nih.gov/38543128/>

PMID 38280086 — Fernandes M, Placidi F, Mercuri NB, Liguori C. Daridorexant treatment for chronic insomnia: a real-world retrospective single-center study.. Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology. 2024;45(7):3443-3448. doi:10.1016/j.smrv.2020.101332 PMID:38280086.

Why flagged: INCLUDE — INCLUDED: human record in which the medicine is implicated in a reported adverse event, tolerability or safety finding.
Basis: "This retrospective observational study aimed to describe real-world data on daridorexant effectiveness and safety in adult patients with CID." "CONCLUSIONS: This study suggests daridorexant to be effective and safe in real-world CID treatment whether used as a first-ever treatment, switch, or add-on, as reflected by subjective and objective measures and the absence of serious treatment-related adverse events."
Source: <https://pubmed.ncbi.nlm.nih.gov/38280086/>

Every record, with its decision

PMID	Decision	Code	Reason
42888253	INCLUDE	INCLUDE	INCLUDE — INCLUDED: human record in which the medicine is implicated in a reported adverse event, tolerability or safety finding.
42873187	EXCLUDE	X2	X2 — NO_NEW_CASES: a review, editorial, comment, guideline or meta-analysis carrying no new case data.
42864752	EXCLUDE	X4	X4 — DRUG_NOT_IMPLICATED: the medicine is mentioned, but no reported adverse event is attributed to it.
42813493	EXCLUDE	X2	X2 — NO_NEW_CASES: a review, editorial, comment, guideline or meta-analysis carrying no new case data.
42674807	INCLUDE	INCLUDE	INCLUDE — INCLUDED: human record in which the medicine is implicated in a reported adverse event, tolerability or safety finding.
42595319	EXCLUDE	X2	X2 — NO_NEW_CASES: a review, editorial, comment, guideline or meta-analysis carrying no new case data.
42453571	EXCLUDE	X2	X2 — NO_NEW_CASES: a review, editorial, comment, guideline or meta-analysis carrying no new case data.
42437946	EXCLUDE	X6	X6 — STUDY_PROTOCOL: a study protocol or design paper reporting no results; it can contain no case.
42422713	EXCLUDE	X3	X3 — NO_SAFETY_DATA: the record reports no adverse event, tolerability or safety outcome.
42206495	EXCLUDE	X2	X2 — NO_NEW_CASES: a review, editorial, comment, guideline or meta-analysis carrying no new case data.
42171662	INCLUDE	INCLUDE	INCLUDE — INCLUDED: human record in which the medicine is implicated in a reported adverse event, tolerability or safety finding.
42143581	EXCLUDE	X2	X2 — NO_NEW_CASES: a review, editorial, comment, guideline or meta-analysis carrying no new case data.
42045086	EXCLUDE	X2	X2 — NO_NEW_CASES: a review, editorial, comment, guideline or meta-analysis carrying no new case data.
41942161	EXCLUDE	X6	X6 — STUDY_PROTOCOL: a study protocol or design paper reporting no results; it can contain no case.
41817674	EXCLUDE	X2	X2 — NO_NEW_CASES: a review, editorial, comment, guideline or meta-analysis carrying no new case data.
41719767	EXCLUDE	X4	X4 — DRUG_NOT_IMPLICATED: the medicine is mentioned, but no reported adverse event is attributed to it.
41700897	EXCLUDE	X4	X4 — DRUG_NOT_IMPLICATED: the medicine is mentioned, but no reported adverse event is attributed to it.
41665171	EXCLUDE	X2	X2 — NO_NEW_CASES: a review, editorial, comment, guideline or meta-analysis carrying no new case data.
41506007	INCLUDE	INCLUDE	INCLUDE — INCLUDED: human record in which the medicine is implicated in a reported adverse event, tolerability or safety finding.
41490393	EXCLUDE	X4	X4 — DRUG_NOT_IMPLICATED: the medicine is mentioned, but no reported adverse event is attributed to it.
41273062	EXCLUDE	X2	X2 — NO_NEW_CASES: a review, editorial, comment, guideline or meta-analysis carrying no new case data.
41262489	INCLUDE	INCLUDE	INCLUDE — INCLUDED: human record in which the medicine is implicated in a reported adverse event, tolerability or safety finding.
41217192	INCLUDE	INCLUDE	INCLUDE — INCLUDED: human record in which the medicine is implicated in a reported adverse event, tolerability or safety finding.
41109037	EXCLUDE	X2	X2 — NO_NEW_CASES: a review, editorial, comment, guideline or meta-analysis carrying no new case data.
41101148	EXCLUDE	X2	X2 — NO_NEW_CASES: a review, editorial, comment, guideline or meta-analysis carrying no new case data.
40943625	EXCLUDE	X2	X2 — NO_NEW_CASES: a review, editorial, comment, guideline or meta-analysis carrying no new case data.
40776640	INCLUDE	INCLUDE	INCLUDE — INCLUDED: human record in which the medicine is implicated in a reported adverse event, tolerability or safety finding.
40660750	INCLUDE	INCLUDE	INCLUDE — INCLUDED: human record in which the medicine is implicated in a reported adverse event, tolerability or safety finding.
40649305	EXCLUDE	X4	X4 — DRUG_NOT_IMPLICATED: the medicine is mentioned, but no reported adverse event is attributed to it.
40644919	EXCLUDE	X4	X4 — DRUG_NOT_IMPLICATED: the medicine is mentioned, but no reported adverse event is attributed to it.
40557879	INCLUDE	INCLUDE	INCLUDE — INCLUDED: human record in which the medicine is implicated in a reported adverse event, tolerability or safety finding.
40555730	EXCLUDE	X2	X2 — NO_NEW_CASES: a review, editorial, comment, guideline or meta-analysis carrying no new case data.
40153194	EXCLUDE	X4	X4 — DRUG_NOT_IMPLICATED: the medicine is mentioned, but no reported adverse event is attributed to it.
40143154	EXCLUDE	X4	X4 — DRUG_NOT_IMPLICATED: the medicine is mentioned, but no reported adverse event is attributed to it.
40133470	EXCLUDE	X2	X2 — NO_NEW_CASES: a review, editorial, comment, guideline or meta-analysis carrying no new case data.
40083090	INCLUDE	INCLUDE	INCLUDE — INCLUDED: human record in which the medicine is implicated in a reported adverse event, tolerability or safety finding.
39985333	INCLUDE	INCLUDE	INCLUDE — INCLUDED: human record in which the medicine is implicated in a reported adverse event, tolerability or safety finding.
39641404	INCLUDE	INCLUDE	INCLUDE — INCLUDED: human record in which the medicine is implicated in a reported adverse event, tolerability or safety finding.
39543812	EXCLUDE	X2	X2 — NO_NEW_CASES: a review, editorial, comment, guideline or meta-analysis carrying no new case data.
39166117	INCLUDE	INCLUDE	INCLUDE — INCLUDED: human record in which the medicine is implicated in a reported adverse event, tolerability or safety finding.
39128336	INCLUDE	INCLUDE	INCLUDE — INCLUDED: human record in which the medicine is implicated in a reported adverse event, tolerability or safety finding.
39118245	INCLUDE	INCLUDE	INCLUDE — INCLUDED: human record in which the medicine is implicated in a reported adverse event, tolerability or safety finding.
39116704	INCLUDE	INCLUDE	INCLUDE — INCLUDED: human record in which the medicine is implicated in a reported adverse event, tolerability or safety finding.
39047305	EXCLUDE	X2	X2 — NO_NEW_CASES: a review, editorial, comment, guideline or meta-analysis carrying no new case data.
39019232	INCLUDE	INCLUDE	INCLUDE — INCLUDED: human record in which the medicine is implicated in a reported adverse event, tolerability or safety finding.
38814132	INCLUDE	INCLUDE	INCLUDE — INCLUDED: human record in which the medicine is implicated in a reported adverse event, tolerability or safety finding.
38804896	INCLUDE	INCLUDE	INCLUDE — INCLUDED: human record in which the medicine is implicated in a reported adverse event, tolerability or safety finding.
38736033	EXCLUDE	X4	X4 — DRUG_NOT_IMPLICATED: the medicine is mentioned, but no reported adverse event is attributed to it.
38657467	EXCLUDE	X4	X4 — DRUG_NOT_IMPLICATED: the medicine is mentioned, but no reported adverse event is attributed to it.
38644625	INCLUDE	INCLUDE	INCLUDE — INCLUDED: human record in which the medicine is implicated in a reported adverse event, tolerability or safety finding.
38622003	INCLUDE	INCLUDE	INCLUDE — INCLUDED: human record in which the medicine is implicated in a reported adverse event, tolerability or safety finding.
38586124	EXCLUDE	X4	X4 — DRUG_NOT_IMPLICATED: the medicine is mentioned, but no reported adverse event is attributed to it.
38551874	EXCLUDE	X4	X4 — DRUG_NOT_IMPLICATED: the medicine is mentioned, but no reported adverse event is attributed to it.
38543128	INCLUDE	INCLUDE	INCLUDE — INCLUDED: human record in which the medicine is implicated in a reported adverse event, tolerability or safety finding.
38472696	EXCLUDE	X4	X4 — DRUG_NOT_IMPLICATED: the medicine is mentioned, but no reported adverse event is attributed to it.
38401406	EXCLUDE	X2	X2 — NO_NEW_CASES: a review, editorial, comment, guideline or meta-analysis carrying no new case data.
38280086	INCLUDE	INCLUDE	INCLUDE — INCLUDED: human record in which the medicine is implicated in a reported adverse event, tolerability or safety finding.
37950346	EXCLUDE	X2	X2 — NO_NEW_CASES: a review, editorial, comment, guideline or meta-analysis carrying no new case data.
37858005	EXCLUDE	X4	X4 — DRUG_NOT_IMPLICATED: the medicine is mentioned, but no reported adverse event is attributed to it.
37086045	EXCLUDE	X2	X2 — NO_NEW_CASES: a review, editorial, comment, guideline or meta-analysis carrying no new case data.

What this record is not

It is not a causality, expectedness or seriousness assessment. Those are the client's qualified person's determination.
It is not a regulatory submission, and it does not replace the MAH's own literature-search record.
Single-pass demonstration run. Production delivery applies dual independent screening with adjudication.