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 @ 4:35 PM
Ignite Modification Date: 2025-12-25 @ 2:26 PM
NCT ID: NCT01449266
Description: Adverse events (AEs) were followed from the subject's screening to the first safety follow-up visit (3 weeks +/- 2 days after the Dotarem® injection). At the second safety follow-up visit (3 months +/- 4 days after the Dotarem® injection), only Serious Adverse Events (SAEs) were evaluated.
Frequency Threshold: 0
Time Frame: Safety assessment was performed at the day 1, day 2, and day 4 after Dotarem® injection. Two safety follow-up visits were performed at 3 weeks (+/- 2 days) and at 3 months (+/- 4 days) after Dotarem® injection.
Study: NCT01449266
Study Brief: Safety and Dialysability of Dotarem® in Dialysed Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Dotarem® Injected Patients Male or female, aged ≥18 years • Subjects suffering from end-stage renal failure who require hemodialysis treatment for 3 times per week (or equivalent to allow overnight dialysis being rescheduled as appropriate per protocol) Dotarem: Dotarem® was administered at a single dose of 0.1 mmoL/kg (0.2 mL/kg). None None 4 10 8 10 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
moderate sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (15.0) View
severe respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (15.0) View
severe peripheral ischemia SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (15.0) View
moderate thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (15.0) View
severe urosepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (15.0) View
Dialysis device insertion SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (15.0) View
Nephrectomy SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (15.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (15.0) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (15.0) View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (15.0) View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (15.0) View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (15.0) View
influenza-like illness SYSTEMATIC_ASSESSMENT General disorders MedDRA (15.0) View
thirst SYSTEMATIC_ASSESSMENT General disorders MedDRA (15.0) View
Procedural pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (15.0) View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (15.0) View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (15.0) View
Dizziness postural SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (15.0) View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (15.0) View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (15.0) View