Healthcare
17 columns
200 rows
8 formats

Patient Clinical Trial Adverse Events

This dataset provides a comprehensive, structured record of adverse events reported by participants in clinical trials, including detailed event descriptions, severity, outcomes, and relationships to study drugs. It enables robust safety monitoring, regulatory compliance, and in-depth analysis of clinical trial safety data across multiple sites and studies.

last updated 22 Jul 2025
by GoMask

The brief that made it

Regulatory safety reporting and compliance for clinical trials

Sample rows

preview · 8 of 200 rows · all 17 columns

adverse_event_idstring	reporter_rolestring	serious_eventboolean	trial_idstring	patient_idstring	site_idstring	event_termstring	event_start_datedate	event_end_datedate	event_severitystring	event_outcomestring	related_to_study_drugboolean	action_taken_with_study_drugstring	concomitant_medicationstring	event_reported_datedatetime	reporter_idstring	event_descriptionstring
AE000001	Patient	false	T-01	P0001	S-101	Headache	2024-05-13	2024-05-14	Mild	Recovered	false	None	None	2024-05-14T10:34:16	PT-3021	Mild headache lasting several hours, no medication required.
AE000002	Patient	false	T-03	P0002	S-114	Nausea	2024-04-26	2024-04-27	Mild	Recovered	false	Not Applicable	blank	2024-04-27T13:21:40	PT-2132	Patient reported mild nausea in the morning.
AE000003	Patient	false	T-04	P0003	S-129	Dizziness	2024-04-29	2024-04-30	Mild	Recovered	false	None	None	2024-04-30T09:42:11	PT-1087	Dizziness after medication, resolved after rest.
AE000004	Patient	false	T-02	P0004	blank	Mild Rash	2024-05-31	2024-06-02	Mild	Recovered	false	None	Cetirizine	2024-06-02T17:24:03	PT-2369	blank
AE000005	Patient	false	T-01	P0005	blank	Fatigue	2024-04-17	blank	Mild	Not Recovered	false	None	blank	2024-04-20T11:35:30	PT-1874	blank
AE000006	Patient	false	T-05	P0006	S-133	Cough	2024-03-29	2024-03-31	Mild	Recovered	false	Not Applicable	Dextromethorphan	2024-03-31T15:15:12	PT-1467	Dry cough, lasted for 2 days.
AE000007	Patient	false	T-03	P0007	blank	Injection site pain	2024-05-19	2024-05-20	Mild	Recovered	false	None	blank	2024-05-20T19:08:50	PT-1220	Mild pain at injection site, resolved after 1 day.
AE000008	Patient	false	T-01	P0008	S-108	Runny nose	2024-03-24	2024-03-26	Mild	Recovered	false	None	Loratadine	2024-03-26T09:04:38	PT-1208	Patient had runny nose for two days.
AE000009	Patient	false	T-02	P0009	blank	Mild Insomnia	2024-04-12	blank	Mild	Not Recovered	false	Not Applicable	blank	2024-04-15T13:21:29	PT-1145	blank
AE000010	Patient	false	T-01	P0010	S-101	Back pain	2024-05-10	2024-05-12	Mild	Recovered	false	None	Acetaminophen	2024-05-12T18:03:09	PT-1740	Lower back pain, managed with acetaminophen.
AE000011	Study Nurse	false	T-06	P0011	S-145	Nasal congestion	2024-05-02	2024-05-05	Moderate	Recovered	false	None	Cetirizine	2024-05-05T14:07:54	RN-1121	Moderate nasal congestion, resolved with antihistamines.
AE000012	Study Nurse	false	T-01	P0012	S-101	Vomiting	2024-03-15	2024-03-17	Moderate	Recovered	true	Dose Reduced	blank	2024-03-17T08:13:22	RN-1112	blank
AE000013	Study Nurse	false	T-03	P0013	S-114	Joint pain	2024-04-03	2024-04-09	Moderate	Recovered	true	Drug Interrupted	Ibuprofen	2024-04-09T16:25:03	RN-1194	Reported moderate joint pain in knees and elbows.
AE000014	Study Nurse	false	T-04	P0014	S-129	Abdominal pain	2024-02-24	2024-02-28	Moderate	Recovered	false	None	Omeprazole	2024-02-28T11:59:36	RN-1053	Intermittent moderate abdominal pain, improved after 4 days.
AE000015	Study Nurse	false	T-01	P0015	S-108	Mild chest pain	2024-05-23	blank	Moderate	Not Recovered	false	None	None	2024-05-25T12:10:44	RN-1278	blank
AE000016	Study Nurse	false	T-02	P0016	S-112	Moderate fever	2024-03-14	2024-03-16	Moderate	Recovered	false	Not Applicable	Acetaminophen	2024-03-16T07:33:11	RN-1284	Fever reached 38.2C, resolved with acetaminophen.
AE000017	Study Nurse	false	T-06	P0017	S-145	Allergic reaction	2024-04-06	2024-04-08	Moderate	Recovering	true	Dose Reduced	Diphenhydramine	2024-04-08T10:47:26	RN-1301	Moderate allergic reaction, treated with antihistamines.
AE000018	Study Nurse	false	T-03	P0018	blank	Moderate dizziness	2024-05-03	2024-05-10	Moderate	Recovered	true	Dose Reduced	None	2024-05-10T16:21:41	RN-1109	blank
AE000019	Study Nurse	false	T-05	P0019	S-133	Moderate muscle pain	2024-02-19	2024-02-24	Moderate	Recovered	false	None	Ibuprofen	2024-02-24T08:18:14	RN-1142	Muscle pain in arms and legs, lasted 5 days.
AE000020	Study Nurse	false	T-01	P0020	S-108	Moderate nausea	2024-05-22	2024-05-25	Moderate	Recovered	true	Drug Interrupted	blank	2024-05-25T18:14:31	RN-1093	Patient experienced moderate nausea, resolved in three days.

What the 200 rows show

from the 200-row sample

Investigator (reporter role) stands out: 71 of its 72 rows have serious_event = true, against 3 of 124 for the rest.

37%serious_event = true
5event severities
6event outcomes
6action taken with study drugs

Serious event rate by reporter_roleserious_event = true

trial_id200 rows · top 10 of 16 values

T-0149
T-0321
T-0517
T-0416
T-0616
T-0213
T-1213
T-0712
T-0911
T-0811

17 columns by typefrom the column list below

string 12
date 2
datetime 1
boolean 2

Columns

17 columns in three groups

blueprint · 17 columns
column	type	description	example
Text 12 columns
`adverse_event_id`	string	Unique identifier for each reported adverse event.unique	AE000001
`patient_id`	string	Unique identifier for the clinical trial participant experiencing the adverse event.	P0001
`trial_id`	string	Unique identifier for the clinical trial in which the patient is enrolled.	T-01
`site_id`	string	Identifier for the clinical trial site where the event was reported.optional	S-101
`event_term`	string	Standardized medical term describing the adverse event (e.g., MedDRA preferred term).	Headache
`event_description`	string	Detailed narrative description of the adverse event.optional	Mild headache lasting sev…
`event_severity`	string	Severity of the adverse event as assessed by the investigator.Mild · Moderate · Severe · Life-threatening · Fatal	Mild
`event_outcome`	string	Outcome of the adverse event.6 values	Recovered
`action_taken_with_study_drug`	string	Action taken with the study drug as a result of the adverse event.6 values · optional	None
`concomitant_medication`	string	Name(s) of any concomitant medication(s) taken at the time of the adverse event.optional	None
`reporter_role`	string	Role of the individual reporting the event (e.g., Investigator, Study Nurse, Patient).Investigator · Study Nurse · Patient · Other · optional	Patient
`reporter_id`	string	Unique identifier for the person reporting the adverse event.optional	PT-3021
Dates and times 3 columns
`event_start_date`	date	Date when the adverse event began.	2024-05-13
`event_end_date`	date	Date when the adverse event resolved or ended (if applicable).optional	2024-05-14
`event_reported_date`	datetime	Date and time when the adverse event was reported to the study team.	2024-05-14T10:34:16
True or false 2 columns
`serious_event`	boolean	Indicates whether the adverse event is classified as serious according to regulatory definitions.	false
`related_to_study_drug`	boolean	Indicates if the adverse event was assessed as related to the investigational product.	false

Use it for

A healthcare dashboard
The serious_event rate, serious_event by reporter_role and a breakdown of trial_id. Excel, Power BI or Tableau.
Why do 74 of 200 rows have serious_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 events200
AE000001Patient
AE000021Investig…
AE000022Investig…
A software demo
Believable adverse events with patient_id, trial_id and site_id to fill a screen in front of a buyer.

This dataset200 rows17 columns

Yours1,000 rows17 columnssite_id: UK only

blueprint · patient-clinical-trial-adverse-events

Behind this dataset

Same schema. As many rows as you need.

These 200 rows came out of a blueprint — 17 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

Each event links to patient, drug, and trial phase.
Event severity and outcome recorded.
Onset and resolution dates provided.
Multiple events per patient possible.

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: patient-clinical-trial-adverse-events

What should your data show?

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Sample rows

What the 200 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?