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 @ 10:22 PM
Ignite Modification Date: 2025-12-25 @ 7:54 PM
NCT ID: NCT04622735
Description: None
Frequency Threshold: 0
Time Frame: 10 days
Study: NCT04622735
Study Brief: Nefopam/Paracetamol Fixed Dose Combination in Acute Pain After Impacted Third Molar Extraction
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
FDC Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2) Each dose: 2 tablets (included in masking capsule) nefopam hydrochloride 30mg / paracetamol 500mg X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day. 0 None 0 107 39 107 View
Paracetamol 500 mg (X2) Each dose: 2 tablets (included in masking capsule) Paracetamol 500 Mg Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day. 0 None 0 108 25 108 View
Nefopam Hydrochloride 30 mg (X2) Each dose: 2 tablets (included in masking capsule) Nefopam HCl 30 MG Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day. 0 None 0 106 35 106 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
LYMPHADENOPATHY SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
PALPITATIONS SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
TACHYCARDIA SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
EAR PAIN SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
EAR DISCOMFORT SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
MOTION SICKNESS SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
VISUAL IMPAIRMENT SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
VOMITIN SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
DRY MOUTH SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
DIARRHOEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
TOOTHACHE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
ABDOMINAL PAIN SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
ABDOMINAL PAIN UPPER SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
CONSTIPATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
DYSPEPSIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
MOUTH ULCERATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
RETCHING SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
PYREXIA SYSTEMATIC_ASSESSMENT General disorders MedDRA View
FATIGUE SYSTEMATIC_ASSESSMENT General disorders MedDRA View
SWELLING FACE SYSTEMATIC_ASSESSMENT General disorders MedDRA View
ASTHENIA SYSTEMATIC_ASSESSMENT General disorders MedDRA View
CHILLS SYSTEMATIC_ASSESSMENT General disorders MedDRA View
FEELING HOT SYSTEMATIC_ASSESSMENT General disorders MedDRA View
ILLNESS SYSTEMATIC_ASSESSMENT General disorders MedDRA View
NON-CARDIAC CHEST PAIN SYSTEMATIC_ASSESSMENT General disorders MedDRA View
ALVEOLAR OSTEITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
WOUND INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
ABSCESS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
POST PROCEDURAL INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
RHINITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
RHINITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
OROPHARYNGEAL PAIN SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
HYPERHIDROSIS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
NIGHT SWEATS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
RASH PRURITIC SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
SKIN DISCOLOURATION SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
HOT FLUSH SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
FLUSHING SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
CONTUSION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
POST PROCEDURAL HAEMATOMA SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
POST PROCEDURAL OEDEMA SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
PROCEDURAL PAIN SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
PROCEDURAL VOMITING SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
BODY TEMPERATURE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA View
HEART RATE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA View
MUSCLE TWITCHING SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
MUSCULOSKELETAL CHEST PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
MUSCULOSKELETAL STIFFNESS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
PAIN IN JAW SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
TRISMUS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
DIZZINESS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
SOMNOLENCE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
PRESYNCOPE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
DYSGEUSIA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
HYPOAESTHESIA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
LETHARGY SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
PARAESTHESIA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
SYNCOPE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
TREMOR SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
INSOMNIA SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
SLEEP DISORDER SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
CHROMATURIA SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
DYSURIA SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
ERECTILE DYSFUNCTION SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View