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 @ 4:03 AM
Ignite Modification Date: 2025-12-26 @ 2:58 AM
NCT ID: NCT01755702
Description: None
Frequency Threshold: 1
Time Frame: All adverse events that occured in the time frame of start of the investigational product and until five days following last administration of the investigational product, were recorded.
Study: NCT01755702
Study Brief: Paracetamol With Caffeine to Treat Episodic Tension Type Headache
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Paracetamol/Caffeine Participants were administered with two paracetamol/ caffeine caplets (500/65 mg each) and two placebo caplets (matching ibuprofen) orally with approx. 250 mL of water. None None 0 47 2 47 View
Ibuprofen Participants were administered with two 200 mg Ibuprofen caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water. None None 0 50 4 50 View
Paracetamol Participants were administered with two 500 mg paracetamol caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water. None None 0 45 0 45 View
Placebo Participants were administered with four placebo caplets (two caplets matching paracetamol/caffeine and two caplets matching ibuprofen) orally with approx. 250 mL of water. None None 0 45 3 45 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal Pain Upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dry Mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Oral Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pharyngitis Streptococcal SYSTEMATIC_ASSESSMENT Infections and infestations None View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Plantar Fascilitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View