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 @ 5:19 AM
Ignite Modification Date: 2025-12-26 @ 4:26 AM
NCT ID: NCT04305327
Description: Data from the safety analysis set, all participants received at least 1 dose of the investigational medicinal product.
Frequency Threshold: 0
Time Frame: Up to approximately 5 months
Study: NCT04305327
Study Brief: Efficacy and Safety of Brodalumab in Adolescents From 12 to 17 Years of Age With Moderate-to-severe Plaque Psoriasis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Brodalumab Participants were randomised to receive brodalumab subcutaneously (SC) at Weeks 0, 1, 2, and then every 2 weeks until week 50. The dose was determined by the participant's body weight. Participants weighing 30 to \<70 kg received 140 mg brodalumab, participants weighing ≥70 kg received 210 mg brodalumab. Participants randomised at Week 0 to brodalumab would have continued with the allocated treatment until Week 52. 0 None 0 2 2 2 View
Ustekinumab Participants were randomised to receive ustekinumab SC at Week 0 and 4, and then every 12 weeks until Week 50. The dose was determined by the participant's body weight. Participants weighing 30 to \<60 kg received 0.75 mg ustekinumab per kg body weight. Participants weighing ≥60 and ≤100 kg received 45 mg ustekinumab, and those weighing \>100 kg received 90 mg ustekinumab. Participants randomised at Week 0 to ustekinumab would have continued with the allocated treatment until Week 52. 0 None 0 6 3 6 View
Placebo/Brodalumab Participants were randomised to receive placebo at Weeks 0, 1, 2, 4, 6, 8, and 10. Following the initial 12 Weeks of placebo, participants received brodalumab at Weeks 12, 13, 14, and every 2 weeks thereafter, with the last brodalumab dose administered at Week 50. The doses were body weight-dependent, participants weighing 30 to \<70 kg received 140 mg brodalumab or 1.0 mL placebo. Participants weighing ≥70 kg received 210 mg brodalumab or 1.5 mL placebo. 0 None 0 2 0 2 View
Placebo/Ustekinumab Participants were randomised to receive placebo at Weeks 0, 1, 2, 4, 6, 8, and 10. Following the initial 12 Weeks of placebo, participants received ustekimumab at Weeks 12, 16, 28, and 40. Doses of ustekimumab were body weight-dependent, participants weighing 30 to \<60 kg received 0.75 mg/kg. Participants weighing ≥60 and ≤100 kg received 45 mg ustekinumab, and those weighed \>100 kg received 90 mg ustekinumab. 0 None 0 2 2 2 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 25.0. View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 25.0. View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 25.0. View
Tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 25.0. View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 25.0. View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA version 25.0. View
Depression rating scale score increased SYSTEMATIC_ASSESSMENT Investigations MedDRA version 25.0. View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 25.0. View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA version 25.0. View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 25.0. View