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 @ 11:16 PM
Ignite Modification Date: 2025-12-25 @ 8:54 PM
NCT ID: NCT03785756
Description: None
Frequency Threshold: 0
Time Frame: Adverse events were monitored and recorded from the time of signing of the informed consent form until the Follow-up Visit (or Early Termination Visit); a period of up to 30 days. Only treatment-emergent adverse events (those that started or worsened in intensity or relationship to treatment on or after the first dose of study drug) are reported here.
Study: NCT03785756
Study Brief: Efficacy of 300 mg Ibuprofen Prolonged-Release Tablets for the Treatment of Pain After Surgical Removal of Impacted Third Molars
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Prolonged Release Group 2 × 300 mg ibuprofen PR tablets at Hours 0 and 12 2 × placebo of PR tablets at Hours 8 and 16 2 × placebo of IR tablets at Hours 0, 8, 12, and 16 0 None 0 120 11 120 View
Immediate Release Group 2 × 200 mg ibuprofen IR tablets at Hours 0, 8, and 16 2 × placebo of IR tablets at Hour 12 2 × placebo of PR tablets at Hours 0, 8, 12, and 16 0 None 0 120 15 120 View
Placebo Group 2 × placebo of PR tablets at Hours 0, 8, 12, and 16 2 × placebo of IR tablets at Hours 0, 8, 12, and 16 0 None 0 39 12 39 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Aphthous ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Facial pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Puncture site haemorrhage SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Swelling face SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 23.0 View
Alveolar osteitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Tooth infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Vulvovaginal mycotic infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Product administration error SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Throat irritation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View