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 @ 6:48 PM
Ignite Modification Date: 2025-12-25 @ 4:20 PM
NCT ID: NCT02397057
Description: 209 participants were randomized of whom 208 received study drug: 105 who were randomized to Injectafer and 103 who were randomized to placebo. Two participants randomized to Placebo received Injectafer. Therefore the Numbers at Risk comprised 107 for Injectafer 101 for placebo.
Frequency Threshold: 2
Time Frame: 2 years, I month
Study: NCT02397057
Study Brief: Placebo-Controlled Study to Investigate the Efficacy & Safety of Injectafer in the Treatment of RLS
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Injectafer Two doses of Injectafer 750 mg undiluted dose at 100 mg/minute given 5 days apart for a total of 1500 mgs. Injectafer 1 None 6 107 72 107 View
Normal Saline IV Placebo (15ml of Normal Saline) IV push at 2ml/minute Placebo 0 None 4 101 19 101 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Colon cancer stage IV SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 17.0 View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 17.0 View
Gout SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 17.0 View
Cerebral haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 17.0 View
Haemorrhagic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 17.0 View
Diabetes mellitus inadequate control SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 17.0 View
Hypophosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 17.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 17.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 17.0 View
Forearm fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 17.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Feeling hot SYSTEMATIC_ASSESSMENT General disorders MedDRA 17.0 View
Blood pressure increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 17.0 View
Blood phosphorus decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 17.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 17.0 View
Hypophosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 17.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 17.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 17.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 17.0 View
Flushing SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 17.0 View
Gamma-Glutamyl Transferase Increase SYSTEMATIC_ASSESSMENT Investigations MedDRA 17.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 17.0 View
Blood pressure systolic increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 17.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 17.0 View
Hot flush SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 17.0 View