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 @ 5:12 PM
Ignite Modification Date: 2025-12-25 @ 2:50 PM
NCT ID: NCT01468350
Description: Part A: up to 8 days Part B: up to 31 days
Frequency Threshold: 4.2
Time Frame: Up to 31 days
Study: NCT01468350
Study Brief: Safety and Tolerability of Dalfampridine in Subjects With Cerebral Palsy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
PART A: Placebo 6 subjects randomized into Sequence BA (placebo - dalfampridine-ER) 5 subjects randomized into Sequence AB (dalfampridine-ER - placebo) A single witnessed dose of placebo and a single witnessed dose of dalfampridine-ER 10 mg, two days apart None None 0 11 1 11 View
PART A: Dalfampridine-ER 10mg 6 subjects randomized into Sequence BA (placebo - dalfampridine-ER) 5 subjects randomized into Sequence AB (dalfampridine-ER - placebo) A single witnessed dose of placebo and a single witnessed dose of dalfampridine-ER 10 mg, two days apart None None 0 11 2 11 View
PART B: Placebo 12 subjects randomized into Sequence BA (placebo - dalfampridine-ER) 12 subjects randomized into Sequence AB (dalfampridine-ER - placebo) Subjects received multiple doses of placebo and multiple doses of dalfampridine-ER 10mg None None 0 24 6 24 View
PART B: Dalfampridine-ER 10mg 12 subjects randomized into Sequence BA (placebo - dalfampridine-ER) 12 subjects randomized into Sequence AB (dalfampridine-ER - placebo) Subjects received multiple doses of placebo and multiple doses of dalfampridine-ER 10mg None None 0 24 9 24 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache None Nervous system disorders MedDRA (14.1) View
Fatigue None General disorders MedDRA (14.1) View
Diarrhoea None Gastrointestinal disorders MedDRA (14.1) View
Fall None Injury, poisoning and procedural complications MedDRA (14.1) View
Musculoskeletal pain None Musculoskeletal and connective tissue disorders MedDRA (14.1) View
Nasal congestion None Respiratory, thoracic and mediastinal disorders MedDRA (14.1) View
Dyspepsia None Gastrointestinal disorders MedDRA (14.1) View
Gastrooesophageal reflux disease None Gastrointestinal disorders MedDRA (14.1) View
Pain in extremity None Musculoskeletal and connective tissue disorders MedDRA (14.1) View
Somnolence None Nervous system disorders MedDRA (14.1) View
Vomiting None Gastrointestinal disorders MedDRA (14.1) View
Insomnia None Psychiatric disorders MedDRA (14.1) View
Hypoaesthesia None Nervous system disorders MedDRA (14.1) View
Nausea None Gastrointestinal disorders MedDRA (14.1) View
Joint crepitation None Musculoskeletal and connective tissue disorders MedDRA (14.1) View
Rash None Skin and subcutaneous tissue disorders MedDRA (14.1) View