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Table 3 Severity grade of adverse events

From: Probiotics [LGG-BB12 or RC14-GR1] versus placebo as prophylaxis for urinary tract infection in persons with spinal cord injury [ProSCIUTTU]: a study protocol for a randomised controlled trial

ESTIMATING SEVERITY GRADE

PARAMETER

GRADE 1

GRADE 2

GRADE 3

GRADE 4

Clinical adverse event

Symptoms causing no or minimal interference with usual social & functional activities

Symptoms causing greater than minimal interference with usual social & functional activities

Symptoms causing inability to perform usual social & functional activities

Symptoms causing inability to perform basic self-care functions OR Medical or operative intervention indicated to prevent permanent impairment, persistent disability

  1. Grades 1 and 2 Laboratory Abnormality or Clinical Event Continue intervention at the discretion of the investigator
  2. Grade 3 Laboratory Abnormality or Clinical Event Grade 3 clinically significant laboratory abnormalities should be confirmed by repeat testing within three to five calendar days of receipt of results and before discontinuation, unless such a delay is not consistent with good medical practice For grade 3 clinical events, continue if the event is considered to be unrelated to the intervention. For a grade 3 clinical event, or clinically significant laboratory abnormality confirmed by repeat testing, that is considered to be related to the intervention, both oral and bodywash interventions should be withheld until the toxicity returns to ≤ grade 2. When restarting following resolution of the adverse event, both interventions to be restarted simultaneously following discussion with the study monitor
  3. Grade 4 Laboratory Abnormality or Clinical Event For grade 4 clinical event or clinically significant laboratory abnormality confirmed by repeat testing that is considered related to the intervention, the intervention should be permanently discontinued and subjects managed according to local practice. The subject should be followed as clinically indicated until the event resolves to baseline, or is otherwise explained, whichever occurs first. Study interventions may be continued without modification for non-clinically significant grade 4 laboratory abnormality (e.g. triglyceride elevation that is non-fasting or that can be medically managed) or clinical event considered unrelated to the study intervention
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BMC Urology

ISSN: 1471-2490

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