Healthcare
16 columns
100 rows
8 formats

Clinical Trial Adverse Events and Safety Data

This dataset provides comprehensive, standardized reporting of adverse events and safety data from clinical trials, including event details, severity, regulatory coding, and pharmacovigilance notes. It enables robust safety monitoring, regulatory submissions, and data-driven risk assessments for investigational drugs.

last updated 2 Nov 2025
by GoMask

The brief that made it

Regulatory submission and compliance reporting

Sample rows

preview · 8 of 100 rows · all 16 columns

adverse_event_idstring	action_takenstring	severity_gradeinteger	serious_adverse_eventboolean	clinical_trial_idstring	subject_idstring	event_start_datedate	event_end_datedate	related_to_study_drugboolean	meddra_codestring	meddra_termstring	outcomestring	report_datedate	reporter_rolestring	safety_monitoring_notesstring	event_descriptionstring
AE00001	none	2	false	CT2024-001	SUBJ-1001	2024-03-15	2024-03-17	true	10029205	Headache	recovered	2024-03-18	study nurse	Symptoms resolved without intervention.	Patient experienced mild headache and dizziness after study drug administration.
AE00002	dose reduced	3	false	CT2024-002	SUBJ-1012	2024-04-02	2024-04-06	true	10028813	Nausea	recovering	2024-04-07	investigator	Monitored for dehydration, improved after dose reduction.	Subject reported nausea and vomiting post dose.
AE00003	none	1	false	CT2024-003	SUBJ-1023	2024-03-21	blank	false	10037844	Rash	recovering	2024-03-22	study nurse	Subject has history of skin allergies.	Mild rash observed on forearms.
AE00004	medication added	2	false	CT2024-001	SUBJ-1004	2024-03-28	2024-04-01	false	10043063	Dyspnea	recovered	2024-04-02	investigator	Prescribed inhaler, symptoms resolved.	Shortness of breath reported during follow-up.
AE00005	medication added	3	false	CT2024-002	SUBJ-1016	2024-04-10	2024-04-11	true	10036638	Pyrexia	recovered	2024-04-12	study nurse	Acetaminophen administered, fever subsided.	Subject developed fever after second dose.
AE00006	hospitalized	4	true	CT2024-003	SUBJ-1025	2024-03-25	2024-03-28	true	10021900	Abdominal pain	recovered	2024-03-29	investigator	Admitted for observation, no surgical intervention needed.	Severe abdominal pain requiring hospitalization.
AE00007	none	1	false	CT2024-004	SUBJ-1031	2024-04-18	blank	false	10016256	Fatigue	recovering	2024-04-19	study nurse	No intervention needed, monitoring ongoing.	Subject reported mild fatigue during study period.
AE00008	hospitalized	5	true	CT2024-001	SUBJ-1007	2024-03-30	2024-04-02	true	10022117	Anaphylactic reaction	recovered	2024-04-03	investigator	Immediate intervention, patient stabilized.	Patient developed severe allergic reaction, treated in ER.
AE00009	none	1	false	CT2024-002	SUBJ-1013	2024-04-04	2024-04-06	true	10021865	Injection site reaction	recovered	2024-04-07	study nurse	Localized swelling, resolved spontaneously.	Mild injection site reaction.
AE00010	drug discontinued	4	true	CT2024-003	SUBJ-1026	2024-03-27	2024-03-29	true	10012735	Diarrhea	recovering	2024-03-30	investigator	Drug stopped, patient monitored for dehydration.	Severe diarrhea post study drug administration.
AE00011	hospitalized	3	true	CT2024-004	SUBJ-1033	2024-04-21	blank	false	10007541	Chest pain	recovering	2024-04-22	sponsor	Admitted for cardiac evaluation, no acute findings.	Patient experienced chest pain during exercise.
AE00012	dose reduced	2	false	CT2024-001	SUBJ-1009	2024-03-25	2024-03-27	true	10017947	Hepatic enzyme increased	recovered	2024-03-28	investigator	Monitoring continued, values normalized post dose reduction.	Mild elevated liver enzymes detected.
AE00013	medication added	2	false	CT2024-002	SUBJ-1015	2024-04-12	2024-04-13	false	10022001	Insomnia	recovering	2024-04-14	study nurse	Sleep hygiene counseling provided.	Moderate insomnia reported by subject.
AE00014	none	1	false	CT2024-003	SUBJ-1028	2024-03-31	blank	false	10003658	Cough	recovered	2024-04-01	study nurse	No medication required.	Patient developed mild cough.
AE00015	hospitalized	5	true	CT2024-004	SUBJ-1036	2024-04-25	2024-04-27	true	10029519	Neutropenia	recovering	2024-04-28	investigator	Hospitalized, G-CSF administered.	Patient experienced severe neutropenia.
AE00016	none	2	false	CT2024-001	SUBJ-1010	2024-03-29	2024-03-31	true	10012666	Dizziness	recovered	2024-04-01	study nurse	Monitoring, resolved within 48 hours.	Subject reported dizziness after morning dose.
AE00017	none	1	false	CT2024-002	SUBJ-1018	2024-04-15	blank	true	10010774	Constipation	recovering	2024-04-16	investigator	Dietary advice given.	Subject developed mild constipation post medication.
AE00018	medication added	2	false	CT2024-003	SUBJ-1030	2024-04-02	2024-04-05	false	10028411	Myalgia	recovered	2024-04-06	sponsor	NSAIDs prescribed, pain resolved.	Patient developed moderate muscle pain.
AE00019	hospitalized	5	true	CT2024-004	SUBJ-1038	2024-04-27	2024-04-29	true	10041056	Sepsis	fatal	2024-04-30	investigator	Patient expired after ICU admission.	Patient developed severe sepsis.
AE00020	none	1	false	CT2024-001	SUBJ-1011	2024-04-01	2024-04-05	false	10001429	Anxiety	recovering	2024-04-06	study nurse	Referred to counseling.	Patient reported mild anxiety.

What the 100 rows show

from the 100-row sample

Hospitalized (action taken) stands out: 16 of its 16 rows have serious_adverse_event = true, against 9 of 84 for the rest.

25%serious_adverse_event = true
2median severity_grade
3reporter roles
4outcomes

Serious adverse event rate by action_takenserious_adverse_event = true

severity_grade100 rows, in bands of 0.5

Median 2, from 1 to 5.

clinical_trial_id100 rows · top 10 of 14 values

CT2024-00113
CT2024-00213
CT2024-00313
CT2024-00411
CT-091-B5
CT-092-C5
CT-093-D5
CT-094-E5
CT-095-F5
CT-096-G5

16 columns by typefrom the column list below

string 10
integer 1
date 3
boolean 2

Columns

16 columns in four groups

blueprint · 16 columns
column	type	description	example
Text 10 columns
`adverse_event_id`	string	Unique identifier for each reported adverse eventunique	AE00001
`clinical_trial_id`	string	Identifier for the clinical trial in which the adverse event occurred	CT2024-001
`subject_id`	string	Unique identifier for the subject/patient experiencing the adverse event	SUBJ-1001
`event_description`	string	Detailed description of the adverse event	Patient experienced mild …
`meddra_code`	string	MedDRA (Medical Dictionary for Regulatory Activities) code for standardized event classification	10029205
`meddra_term`	string	MedDRA preferred term for the adverse event	Headache
`action_taken`	string	Action taken in response to the adverse event (e.g., dose reduced, drug discontinued, no action)6 values · optional	none
`outcome`	string	Outcome of the adverse event (e.g., recovered, ongoing, fatal)recovered · recovering · not recovered · fatal · unknown	recovered
`reporter_role`	string	Role of the person reporting the event (e.g., investigator, study nurse, sponsor)investigator · study nurse · sponsor · other · optional	study nurse
`safety_monitoring_notes`	string	Additional notes or comments from safety monitoring or pharmacovigilance activitiesoptional	No medication required.
Numbers 1 column
`severity_grade`	integer	Severity grade of the adverse event, typically on a standardized scale (e.g., CTCAE 1-5)1 to 5	2
Dates and times 3 columns
`event_start_date`	date	Date when the adverse event started	2024-03-15
`event_end_date`	date	Date when the adverse event ended (if applicable)optional	2024-03-17
`report_date`	date	Date the adverse event was reported	2024-03-18
True or false 2 columns
`related_to_study_drug`	boolean	Indicates whether the adverse event is related to the study drug	true
`serious_adverse_event`	boolean	Flag indicating if the event qualifies as a Serious Adverse Event (SAE)	false

Use it for

A healthcare dashboard
The serious_adverse_event rate, severity_grade by action_taken and a breakdown of clinical_trial_id. Excel, Power BI or Tableau.
Why do 25 of 100 rows have serious_adverse_event = true?
A root-cause class exercise
Hand out the rows and one question. The answer is in the data, not in the brief.
Adverse events100
AE000012none
AE000064hospital…
AE000085hospital…
A software demo
Believable adverse events with clinical_trial_id, subject_id and event_start_date to fill a screen in front of a buyer.

This dataset100 rows16 columns

Yours1,000 rows16 columns

blueprint · clinical-trial-adverse-events-and-safety-data

Behind this dataset

Same schema. As many rows as you need.

These 100 rows came out of a blueprint — 16 columns with generation rules behind each one. Open it in Data Factory to retune a column, add your own, wire in foreign keys, and run it at the size you actually need.

Rules it was built with

AE ID unique per adverse event
Subject ID and treatment arm
Event term (verbatim) and MedDRA preferred term
Onset date/time and resolution date/time
Severity: mild (Grade 1), moderate (2), severe (3), life-threatening (4), death (5)
CTCAE (Common Terminology Criteria for Adverse Events) grading
Relatedness: unrelated, unlikely, possible, probable, definite
Serious AE (SAE) criteria: death, hospitalization, disability, life-threatening

Rows1,000 rows10,000 rows100,000 rows1,000,000 rows

Open the blueprint in Data Factory

1 credit per row. Preview 20 rows free. Buy rows for the full run.

Exports: CSV, JSON, JSONL, Parquet, SQL, Excel, TSV, XML
Licence: yours to use, including commercially
API slug: clinical-trial-adverse-events-and-safety-data

What should your data show?

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Sample rows

What the 100 rows show

Columns

Use it for

A healthcare dashboard

A root-cause class exercise

A software demo

Make it yours.

Same schema. As many rows as you need.

More in Healthcare

What should your data show?