What is the difference between adverse events and treatment emergent adverse events?

Q: What is the difference between treatment emergent and treatment related adverse events?

While the treatment emergent AEs refers to adverse events temporally related to the study treatment, the drug-related AEs refers to the causality assessment by the investigator.

Q: What are treatment emergent adverse events?

TEAE = treatment-emergent AE. a. TEAE is defined as an AE that began after the start of trial medication treatment; or if the event was continuous from baseline and was serious, trial medication-related, or resulted in death, discontinuation, or interruption or reduction of trial therapy.

Q: What are the different types of adverse events?

What is a Serious Adverse Event?.

Q: What is the difference between adverse event and serious adverse event?

Adverse Events (AEs) can be classified as mild, moderate or severe. An AE can be severe without being a Serious Adverse Event. A Serious Adverse Event (SAE) is an adverse event that meets one of the following criteria: results in death.

Observational Study

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Comparison of Treatment Emergent Adverse Events in Men With Premature Ejaculation Treated With Dapoxetine and Alternate Oral Treatments: Results From a Large Multinational Observational Trial
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What is the difference between treatment emergent and treatment related adverse events?
What are treatment emergent adverse events?
What are the different types of adverse events?
What is the difference between adverse event and serious adverse event?

doi: 10.1016/j.jsxm.2015.12.017. Epub 2016 Jan 21.

Affiliations

PMID: 26805941
DOI: 10.1016/j.jsxm.2015.12.017

Observational Study

Comparison of Treatment Emergent Adverse Events in Men With Premature Ejaculation Treated With Dapoxetine and Alternate Oral Treatments: Results From a Large Multinational Observational Trial

Paolo Verze et al. J Sex Med. 2016 Feb.

Abstract

Introduction: Dapoxetine (DPX) has a pharmacokinetic profile suggesting a low rate of class-related adverse events (AEs).

Aim: To assess the incidence of treatment emergent AEs (TEAEs) of special interest (known associations with selective serotonin reuptake inhibitors and/or potential clinically relevant AEs), and the related discontinuation rate in patients with premature ejaculation (PE) treated with DPX or alternate oral treatment (AOT), in routine clinical practice.

Methods: In a prospective, 12-week, open-label, postmarketing observational, multinational study (PAUSE), 7545 patients were enrolled and divided into 2 groups: DPX 30-60 mg and AOT.

Main outcome measures: The incidence rate of predefined TEAEs of special interest (mood and related, neurocognitive related, cardiovascular, urogenital and sexual function, accidental injury, and abnormal bleeding) in the DPX and the AOT groups, and the rate of AEs leading to study discontinuation.

Results: The safety analysis was performed on 6128 patients treated with DPX and 1417 with AOT. The incidence of TEAEs of special interest in each AE category was greater for patients treated with AOT than with DPX. The higher differences were observed in the neurocognitive-related category (DPX 1.9% vs. AOT 4.7%; P < .001), in the mood and related category (DPX 0.4% vs. AOT 1.1%; P < .001), and in the urogenital system/sexual function (DPX 0.4% vs. AOT 0.8%; P = .04). Cardiovascular TEAEs were the only AEs numerically greater in the DPX group (1.3 vs. 1.6%, P = .34). The overall discontinuation rate was 10.9% in the DPX group and 6.9% in the AOT group).

Conclusion: DPX has a favorable safety profile in terms of class-related TEAEs and clinically relevant AEs of special interest. In particular, it shows a significantly better safety profile in mood and related AEs, neurocognitive-related AEs, urogenital system, and sexual function, compared to the AOT group in the study population.

Keywords: Cardiovascular Events; Dapoxetine; Fluoxetine; Paroxetine; SSRI; Safety.

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While the treatment emergent AEs refers to adverse events temporally related to the study treatment, the drug-related AEs refers to the causality assessment by the investigator.

What are treatment emergent adverse events?

TEAE = treatment-emergent AE. a. TEAE is defined as an AE that began after the start of trial medication treatment; or if the event was continuous from baseline and was serious, trial medication-related, or resulted in death, discontinuation, or interruption or reduction of trial therapy.

What are the different types of adverse events?

What is a Serious Adverse Event?.

Death. ... .

Life-threatening. ... .

Hospitalization (initial or prolonged) ... .

Disability or Permanent Damage. ... .

Congenital Anomaly/Birth Defect. ... .

Required Intervention to Prevent Permanent Impairment or Damage (Devices) ... .

Other Serious (Important Medical Events).

What is the difference between adverse event and serious adverse event?

Adverse Events (AEs) can be classified as mild, moderate or severe. An AE can be severe without being a Serious Adverse Event. A Serious Adverse Event (SAE) is an adverse event that meets one of the following criteria: results in death.