Serious adverse event

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A serious adverse event (SAE) in human drug trials are defined as any untoward medical occurrence that at any dose results in

  1. death,
  2. is life-threatening
  3. requires inpatient hospitalization or prolongation of existing hospitalization
  4. results in persistent or significant disability/incapacity, or
  5. is a congenital anomaly/birth defect.[1]


The term "life-threatening" in the definition of "serious" refers to an event in which the patient was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe.[1] Adverse events are further defined as “Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.”[1]

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[edit] Research

Investigators in human clinical trials are obligated to report these events in clinical study reports [2] . Research suggests that these events are often inadequately reported in publicly available reports.[3] Because of the lack of these data and uncertainty about methods for synthesising them, individuals conducting systematic reviews and meta-analysis of therapeutic interventions often unknowingly overemphasise health benefit.[4] In order to balance the overemphasis on benefit, scholars have called for more complete reporting of harm from clinical trials.[5]


[edit] Related Terms

Serious adverse effects , serious adverse reactions, or suspected unexpected serious adverse reactions (SUSAR) are serious adverse events judged to be related to therapy. A SUSAR is to be reported to the regulatory authority by using the CIOMS form:

  • The event must be a SAE.
  • There must be a certain degree of probability that the event is an adverse reaction on the administered drug.
  • The adverse reaction must be unexpected, that is to say, not foreseen in the SPC text (Summary of Product Characteristics (for an authorised medicinal product)) or the Investigator’s Brochure (for an unauthorised medicinal product).

[edit] Footnotes

  1. ^ a b c Expert Working Group (Efficacy) of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). (August 25, 2007). Guideline for Industry - Clinical safety data management: definitions and standards for expedited reporting. (PDF). FDA Center for Drug Evaluation and Research.}
  2. ^ Expert working group (efficacy) of the international conference on harmonization of technical requirements for registration of pharmaceuticals for human use. (August 25, 2007). [http://www.fda.gov/cder/guidance/iche3.pdf Guideline for Industry Structure and Content of Clinical Study Reports.] (PDF). FDA Center for Drug Evaluation and Research.}
  3. ^ Ioannidis JP, Lau J. (2001). "Completeness of safety reporting in randomized trials: an evaluation of 7 medical areas.". JAMA 285(4): 437–43. doi:10.1001/jama.285.4.437. PMID 11242428. 
  4. ^ Chou R, Helfand M. (2005). "Challenges in systematic reviews that assess treatment harms.". Ann Intern Med 142(12 Pt 2): 1090–0. PMID 15968034. 
  5. ^ Ioannidis JP, Evans SJ, Gøtzsche PC, O'Neill RT, Altman DG, Schulz K, Moher D; CONSORT Group. (2004). "Better reporting of harms in randomized trials: an extension of the CONSORT statement.". Ann Intern Med 141(10): 781–8. PMID 15545678. 

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