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: 2025-12-24 @ 5:29 PM
Ignite Modification Date: 2025-12-25 @ 3:03 PM
NCT ID: NCT02080468
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT02080468
Study Brief: Evaluate the Effect of Ethinyl Estradiol/Norgestimate on the Pharmacokinetics of Lomitapide in Healthy Female Subjects
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Lomitapide & EE/Norgestimate - Taken Together 2 single oral doses of lomitapide (20 mg) (Day 1 \& Day 22) 21 single oral doses of EE/Norgestimate(Day 8 through day 28) lomitapide: 20 mg EE/norgestimate: 1x0.035-mg EE/0.25-mg norgestimate tablet 0 None 0 16 8 16 View
Lomitapide & EE/Norgestimate - Taken 12 Hours Apart 2 single oral doses of lomitapide (20 mg) (Day 1 \& Day 22) 21 single oral doses of EE/Norgestimate(Day 9 through day 29) lomitapide: 20 mg EE/norgestimate: 1x0.035-mg EE/0.25-mg norgestimate tablet 0 None 0 16 7 16 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (16.1) View
Vomitting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (16.1) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (16.1) View
Procedural dizziness SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (16.1) View
Procedural Nausea SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (16.1) View
Laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (16.1) View
Vessel Punction Site Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA (16.1) View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (16.1) View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (16.1) View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (16.1) View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (16.1) View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (16.1) View
Sensory disturbance SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (16.1) View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (16.1) View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (16.1) View
Pulmonary congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (16.1) View
Rhinorrhea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (16.1) View
Sneezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (16.1) View
Dysmenorrhoea SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (16.1) View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (16.1) View
hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (16.1) View
Fungal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (16.1) View
Body temperature increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (16.1) View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (16.1) View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (16.1) View
Hot flush SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (16.1) View