ACUITY DB result tables

It is the most important part of ACUITY database. These tables contain the main data that AdminUI prepares and then VAHub presents.

Mostly, dataset data is just events' data. Events are the main entities whose data is shown on some particular plot, e.g., adverse events data, or lung function data, or conmeds data etc. Typically, an event relates just to a result_patient entry, but there are also more complicated cases.

Common main data

There is some special tables whose data is important in many cases throughout a dataset.

• result_project - projects' data. Projects (drug programmes) are the most common unit of meaning in ACUITY. Generally, each drug programme is dedicated to some particular drug(s) investigation.
• result_study - clinical studies' and datasets' data. They are lower units of meaning than a drug programme, but still quite common. Business hierarchy looks like: each clinical study belongs to some drug programme and is a separate investigation of the drug in some aspect (there can be many of them for some drug), and each dataset belongs to some clinical study and represents basically the set of data belonging to this study. In most cases there is only one dataset in a study, but sometimes there is a need to create some separate set, e.g. fixed for a particular moment, and then there are many datasets belonging to one clinical study. Technically, though, the most important unit of meaning is dataset: there is always a separate set of files for a dataset, other data entities mostly belong to some dataset, and generally it's a dataset that we always work with. That's why, despite that the table named is result_study (for history reasons), each entry represents not a clinical study, but a dataset. There is no unique separate representation for clinical study concept in ACUITY database.
• result_patient - data of patients (subjects) that participated in the drug investigation. The most part of other events in a dataset is related to some patients, so it is quite a common information that is retrieved together with any other dataset information, on each plot etc. Also, there is a set of special plots (Single Subject View) that provides information about one particular subject.
• result_patient_group - data about patients membership in groups and group unification in different groupings.
• result_sc - info about subject ethnic groups.
• result_test - for several types of events (cardiac events, laboratory data, vitals etc), there are some common properties that are taken out to this table (patient ID between them - so these events are linked to patients through this table entries, not directly).
• result_source - info about sources of events data.
• result_drug - info about drugs being investigated in a particular dataset. It may be one or more of them for a dataset.
• result_visit - information about visit of patients. Frequently used for any plots showing any temporal data distribution about patient(s).
• result_withdrawal_completion - data about patient withdrawal; used as temporary storage only during ETL, not used directly in VAHub for presentation.

Adverse events

Adverse events (AE) model is more complicated than for other events.

• result_ae - the adverse events themselves
• result_event_type - types to one of which each AE belongs (e.g. an AE described as "hyperemia in left and right eyes" can belong to the type "EYES RED")
• result_ae_severity - severities of particular AE event (there may be more than one entry for single AE because a severity entry describes AE severity during a particular period of time, and there can be many such periods during the investigation with different severity in each of them)
• result_ae_action_taken - actions taken (about drug administering) on an AE: drug can be discontinued temporarily or permanently, dose may be increased or reduced etc. Relates not to an AE directly, but to an entry of result_ae_severity because more or less severe AE may take different measures).
• result_ae_causality - information about the possibility that an AE cause is some of drugs under investigation.
• result_serious_adverse_event - some AEs are considered as "serious" (defined by result_ae.ae_serious field value); if so, there is some additional data for such AE that is stored in this table.
• result_ae_num_act_taken- info about AE number caused action taken
• result_ae_num_del - info about AE number caused treatment cycle delayed

Conmeds related events

• result_medicine - info about conmeds (drugs other than the investigated one) potentially used by patients during the investigation or before that
• result_conmed_schedule - info about conmed use cases during the investigation. Relates to result_medicine and result_patient

Oncology related events

• result_ctdna - info about circulating tumour DNA
• result_disease_extent - info about oncologic disease extent inside patient body
• result_recist_assessment - info about RECIST (Response Evaluation Criteria in Solid Tumors) assessments
• result_recist_nontarget_lesion - info about RECIST non-target lesions
• result_recist_target_lesion - info about RECIST target lesions

Cardiac data events

• result_eg - info about electrocardiograms
• result_decg - info about dECG
• result_algorithm_outcomes - info about algorithm outcomes. Currently, in ACUITY it is relevant for ECG data only.
• result_lvef - heart left ventricle ejection fraction data.
• result_ci_event - info cardiac ischemic events
• result_cvot - info about cardiovascular outcome trials

Laboratory related events

• result_laboratory - info about laboratory tests; has FKs for result_test, result_source and result_lab_group
• result_lab_group - info about laboratory tests grouping. Currently, is not presented directly anyhow in VAHub.

Liver related events

• result_liver - liver data.
• result_liver_risk_factors - info about liver risk factors.

Lung function related events

• result_lungfunc - info about lung function.
• result_exacerbation - info about lung function disorders exacerbations
• result_exa_severity_map - info about custom severities of exacerbations. Exacerbation severity normally has a text name calculated based on 6 different exacerbation boolean-like properties. The mapping of these properties to the text name may be either standard (that is hardcoded) or custom (that is stored in this table). It is used to calculate severity field and update result_exacerbation table with it during ETL, and VAHub does not use result_exa_severity_map at all, so possibly it should be moved to the mapping tables category.

Pharmacokinetic data related events

• result_pk_concentration - info about pharmacokinetic concentrations (used for exposure data calculation)
• result_stacked_pk_results - drugs pharmacokinetic results data
• result_specimen_collection - info about collection of specimen (userd for exposure data calculation)

Dosing related events

• result_target_med_dos_disc - info about dose discontinuations.
• result_trg_med_dos_schedule - info about dosing schedules (main table about drug doses).

Other events

• result_alcohol_sub_use - info about using of alcohol substances by patient
• result_biomarkers - info about biomarkers
• result_cerebrovascular - cerebrovascular data
• result_chemotherapy - info about chemotherapy
• result_death - info about patient deaths
• result_medical_history - info about medical histories.
• result_nicotine_sub_use - info about nicotine substances use.
• result_patient_reported_data - data reported by patients
• result_randomisation - data used in baseline calculation
• result_surgical_history - info about surgical history
• result_vitals - vitals data