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 @ 10:56 PM
Ignite Modification Date: 2025-12-25 @ 8:24 PM
NCT ID: NCT01029769
Description: spontaneous reporting
Frequency Threshold: 5
Time Frame: Entire 8 weeks of treatment
Study: NCT01029769
Study Brief: Efficacy of an Early Antipsychotic Switch in Case of Poor Initial Response to the Treatment of Schizophrenia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Period 2: Extended 6-week Treatment - Early Non-responders Not Switched double blind continuation of treatment as in period 1; oral olanzapine 5mg to 20mg/d; OR oral amisulpride 200mg to 800mg/d; preferably once daily, encapsulated for blinding 0 None 4 72 7 72 View
Period 1: Initital 2-week Treatment - Amisulpride Treated Patients oral amisulpride 200mg to 800mg/d; preferably once daily, encapsulated for blinding 0 None 3 163 36 163 View
Period 1: Initital 2-week Treatment - Olanzapine Treated Patients oral olanzapine 5mg to 20mg/d; preferably once daily, encapsulated for blinding 1 None 3 164 33 164 View
Period 2: Extended 6-week Treatment - Early Responders double blind continuation of treatment as in period 1; oral olanzapine 5mg to 20mg/d; OR oral amisulpride 200mg to 800mg/d; preferably once daily, encapsulated for blinding 1 None 7 140 32 140 View
Period 2: Extended 6-week Treatment - Early Non-responders Switched double blind switch to the alternative drug not used in period 1; oral olanzapine 5mg to 20mg/d; OR oral amisulpride 200mg to 800mg/d; preferably once daily, encapsulated for blinding 0 None 5 70 21 70 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
prolongation of hospitalisation NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
hospitalisation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
life threatening event NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
life threatening event NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
death NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
life threatening event NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
akathisia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
tremor NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
weight increase NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Insomnia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View