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 @ 6:28 PM
Ignite Modification Date: 2025-12-25 @ 3:58 PM
NCT ID: NCT01179568
Description: We observed no serious adverse medication effects. CGT therapists monitored participant response to emotionally activating procedures; no serious untoward responses were documented.
Frequency Threshold: 0
Time Frame: 5 years
Study: NCT01179568
Study Brief: A Study of Medication With or Without Psychotherapy for Complicated Grief
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Citalopram Citalopram is an Selective Serotonin Reuptake Inhibitor (SSRI) medication. It is combined with grief-focused clinical management. Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion. None None 0 101 0 101 View
Placebo (Sugar Pill) Inactive medication. It is combined with grief-focused clinical management. Placebo: 16 weeks of daily inactive medication. It is administered in a double-blind fashion. None None 0 99 0 99 View
CGT With Citalopram The targeted psychotherapy for complicated grief combined with SSRI medication. Complicated Grief Treatment: Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks. Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion. None None 1 99 0 99 View
CGT With Placebo The targeted psychotherapy for complicated grief combined with inactive medication. Complicated Grief Treatment: Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks. Placebo: 16 weeks of daily inactive medication. Medication is administered in a double-blind fashion. None None 0 96 0 96 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
death by suicide NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Other Events(If Any):