Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-25 @ 1:25 AM
Ignite Modification Date: 2025-12-25 @ 11:36 PM
NCT ID: NCT02643693
Description: The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products as part of the study (including P3L system, the VUSE e-cigarette system or CC). Overall safety population = 22 subjects; P3L exposure = 21 subjects; VUSE exposure = 19 subjects; CC exposure = 19 subjects.
Frequency Threshold: 0
Time Frame: Adverse events were collected over the entire study duration of up to 5 months, with individual subject participation of between three and 11 weeks from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
Study: NCT02643693
Study Brief: User Acceptability of a Nicotine Lactate Delivery System (P3L)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
P3L Product Subject product use was randomly assigned for each ad libitum use session, following a sequence of product exposure comprised of the three products (P3L, VUSE, and CC). 0 None 0 21 14 21 View
VUSE Product Subject product use was randomly assigned for each ad libitum use session, following a sequence of product exposure comprised of the three products (P3L, VUSE, and CC). 0 None 0 19 13 19 View
CC Product Subject product use was randomly assigned for each ad libitum use session, following a sequence of product exposure comprised of the three products (P3L, VUSE, and CC). 0 None 0 19 9 19 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (18.0) View
Disturbance In Attention SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (18.0) View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (18.0) View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (18.0) View
Throat Irritation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (18.0) View
Nasal Discomfort SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (18.0) View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (18.0) View
Feeling Jittery SYSTEMATIC_ASSESSMENT General disorders MedDRA (18.0) View
Chest Discomfort SYSTEMATIC_ASSESSMENT General disorders MedDRA (18.0) View
Chest Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA (18.0) View
Unevaluable Event SYSTEMATIC_ASSESSMENT General disorders MedDRA (18.0) View
Dry Mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
Hypertriglyceridaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (18.0) View
Viral Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.0) View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (18.0) View
Pain in Extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (18.0) View