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 @ 4:16 PM
Ignite Modification Date: 2025-12-25 @ 2:14 PM
NCT ID: NCT02402166
Description: None
Frequency Threshold: 5
Time Frame: From Start of Treatment up to Safety Follow up (Week 9)
Study: NCT02402166
Study Brief: Safety, Tolerability, Pharmacokinetic, and Efficacy Study of SPD489 in Preschool Children With Attention-deficit/Hyperactivity Disorder
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
SPD489 5mg Participants received 5 mg capsule of SPD489 orally once daily from Week 1 up to Week 8 based on the investigator's assessment of participants' response and tolerability. 0 None 0 24 6 24 View
SPD489 10mg Participants received 10 mg capsule of SPD489 orally once daily from Week 2 up to Week 8 based on the investigator's assessment of participants' response and tolerability. 0 None 0 23 7 23 View
SPD489 15mg Participants received 15 mg capsule of SPD489 orally once daily from Week 3 up to Week 8 based on the investigator's assessment of participants' response and tolerability. 0 None 0 18 7 18 View
SPD489 20mg Participants received 20 mg capsule of SPD489 orally once daily from Week 4 up to Week 8 based on the investigator's assessment of participants' response and tolerability. 0 None 0 12 6 12 View
SPD489 30mg Participants received 30 mg capsule of SPD489 orally once daily from Week 5 up to Week 8 based on the investigator's assessment of participants' response and tolerability. 0 None 0 10 6 10 View
SPD489 Participants received 5 mg capsule of SPD489 orally once daily and titrated up to either 10 mg, 15 mg, 20 mg, or 30 mg until an optimal dose was reached within 8 weeks. 0 None 0 24 15 24 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Chest discomfort NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Gastroenteritis viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Blood pressure diastolic increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Weight decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Decreased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.0 View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.0 View
Initial insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.0 View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.0 View
Irritability NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.0 View
Middle insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.0 View
Mood swings NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.0 View
Nasal congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Abdominal pain upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Affect lability NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.0 View
Urticaria NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.0 View