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 @ 2:08 AM
Ignite Modification Date: 2025-12-26 @ 12:35 AM
NCT ID: NCT00769860
Description: Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
Frequency Threshold: 0
Time Frame: Adverse event data was collected for the duration of the subject's participation, 12 months.
Study: NCT00769860
Study Brief: Arimoclomol in Sporadic Inclusion Body Myositis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Arimoclomol Arimoclomol 100 mg TID for 4 months None None 0 16 16 16 View
Placebo Matched placebo pills, 100 mg TID for 4 months None None 1 8 8 8 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Stroke SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Bowel movement problems SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Epigastralgia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Dizziness/tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Conjunctivitis SYSTEMATIC_ASSESSMENT Eye disorders None View
Eye pain SYSTEMATIC_ASSESSMENT Eye disorders None View
Dry eyes SYSTEMATIC_ASSESSMENT Eye disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Throat irritation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Loose stools SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Painful parotids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gas pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pyrosis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Geographic tongue SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Weight loss SYSTEMATIC_ASSESSMENT General disorders None View
Dizziness SYSTEMATIC_ASSESSMENT General disorders None View
Loss of consciousness SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Sinus infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Tooth infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Erysipelas SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Leg ulcer infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Fall/contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Post-biopsy pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Post-biopsy fatigue SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Pruritus in biopsy scar SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Finger cut SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hyponatremia SYSTEMATIC_ASSESSMENT Investigations None View
High thyroxine levels SYSTEMATIC_ASSESSMENT Investigations None View
Spinal stenosis SYSTEMATIC_ASSESSMENT Investigations None View
Herniated disk SYSTEMATIC_ASSESSMENT Investigations None View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Cramps SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Rheumatoid arthritis flare SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Heat and soreness of proximal lower limbs SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Worsening of restless leg syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Paresthesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Stroke SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Decreased libido SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rosacea SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Insect bite with erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Cold sores SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Tooth extraction SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Sinus surgery SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Solar lentigines removal SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Edema SYSTEMATIC_ASSESSMENT Vascular disorders None View