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 @ 11:54 PM
Ignite Modification Date: 2025-12-25 @ 9:49 PM
NCT ID: NCT01205451
Description: Serious and non-serious adverse events were collected in members of the Safety Set Population, which included all of the enrolled and treated participants.
Frequency Threshold: 0
Time Frame: Serious and non-serious adverse events were collected from the Screening visit (-1 Week) until the end of study visit (Week 12) or earlier, in case of early withdrawal.
Study: NCT01205451
Study Brief: A Multicenter, Open-label, Single Dose Study of the Safety and Efficacy of GSK1358820 (Botulinum Toxin Type A) in Chinese Subjects With Post-stroke Focal Upper Limb Spasticity
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
BOTOX in Original DB Study; BOTOX in OL Study Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters \[mL\]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0). None None 1 53 4 53 View
Placebo in Original DB Study; BOTOX in OL Study Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters \[mL\]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0). None None 0 56 7 56 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cerebral arteriovenous malformation haemorrhagic SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood potassium increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Renal function test abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Hyperlipidaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Dyslipidaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hyperuricaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood glucose increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Protein total decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Epilepsy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View