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: 2025-12-26 @ 11:13 PM
Ignite Modification Date: 2025-12-26 @ 11:13 PM
NCT ID: NCT00135512
Description: All participants who had participated in the study and had received at least 1 dose of the investigational product were included in the safety population and were used for reporting non-SAE and SAE.
Frequency Threshold: 5
Time Frame: All adverse events (AE) and serious adverse events (SAE) were reported up to Week 52.
Study: NCT00135512
Study Brief: Study Of 323U66 SR In Major Depressive 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
Bupropion SR During treatment period, participants received Dose Level 2; bupropion SR 100 mg tablets once daily for 1 week in the morning and then the Dose Level 3; bupropion SR 100 mg tablets BID; morning and evening for the next 1 week of the treatment phase. If no problems were observed in tolerability with insufficient efficacy, then Dose Level 4; bupropion SR 150 mg tablets BID for 6 weeks. Dose reduction back to Dose Level 3 was allowed in participants judged by the investigator to have a safety concern after dose increase to Dose Level 4 and dose adjustment between Dose Levels 3 and 4 was to be chosen optionally. If no tolerability issues were observed at Week 8 of treatment phase, the treatment continued up to a maximum of 52 weeks. One tablet was administered per dose during each dose level. 1 None 14 233 210 233 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA version View
Suicidal ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA version View
Back injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version View
Intentional misuse SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version View
Tibia fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version View
Grand mal convulsion SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version View
Hepatic function abnormal SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA version View
Gastroenteritis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version View
Spinal osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version View
Abortion spontaneous SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA version View
Genital haemorrhage SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA version View
Drug eruption SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA version View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA version View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version View
Thirst SYSTEMATIC_ASSESSMENT General disorders MedDRA version View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA version View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version View
Stomach discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version View