Serious Event

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Serious Event

Serious Adverse Events (SAEs) are adverse events that result in death, are life-threatening, require or prolong hospitalization, cause persistent or significant disability/incapacity, or are congenital anomalies/birth defects. Each serious event is categorized by term, organ system, assessment type, and source vocabulary to provide standardized reporting across clinical trials.

Serious Event path is as follows:

Study -> Results Section -> Adverse Events Module -> Serious Event

Study -> Results Section -> Adverse Events Module -> Serious Event -> Serious Event Stats

Serious Event

Ignite Creation Date: 2025-12-24 @ 10:13 PM
Ignite Modification Date: 2025-12-25 @ 7:48 PM
NCT ID: NCT00934635
Term: Exacerbation of schizophrenic symptoms
Organ System: Psychiatric disorders
Assessment Type: SYSTEMATIC_ASSESSMENT
Source Vocabulary: None
Notes: 13 days after patient completed study a SAE report indicated exacerbation of symptoms after illegal drug intake.He was transferred to locked ward, switched to clozapine and symptoms resolved without sequel.SAE classified unrelated to study medication
Study: NCT00934635
Study Brief: A Positron-Emission-Tomography (PET) Study to Measure the Blockade of Dopamine Receptors (D2) in Specific Areas of the Brain in Relation to the Plasma Concentrations of Paliperidone Extended Release (ER) and Oral Risperidone in Schizophrenia Patients and Healthy Controls
Serious Event Stats (If Any):

Serious Event Stats

Group ID # Events # Affected # At Risk View
EG000 0 0 0 View
EG001 1 1 1 View
EG002 0 0 0 View
EG003 0 0 0 View
EG004 0 0 0 View
EG005 0 0 0 View
EG006 0 0 0 View
EG007 0 0 0 View
EG008 0 0 1 View