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Table 1 The Naranjo scale for adverse drug reaction assessment.

From: Dermatomyositis associated with omalizumab therapy for severe asthma: a case report

 

Question

Yes

No

Don’t know score

1.

Are there previous conclusive reports on this reaction?

+ 1

0

0

2.

Did the adverse event appear after the suspected drug was administered?

+ 2

− 1

0

3.

Did the adverse reaction improve when the drug was discontinued, or a specific antagonist was administered?

+ 1

0

0

4.

Did the adverse reaction reappear when the drug was readministered?

+ 2

− 1

0

5.

Are there alternative causes (other than the drug) that could on their own have caused the reaction?

− 1

+ 2

0

6.

Did the reaction reappear when a placebo was given?

− 1

+ 1

0

7.

Was the drug detected in the blood (or other fluids) in concentrations known to be toxic?

+ 1

0

0

8.

Was the reaction more severe when the dose was increased, or less severe when the dose was decreased?

+ 1

0

0

9.

Did the patient have a similar reaction to the same or similar drug in any previous exposure?

+ 1

0

0

10.

Was the adverse event confirmed by any objective evidence?

+ 1

0

0

  1. Scores of ≥ 9, 5–8, 1–4, ≤ 0 indicate definite, probable, possible, and doubtful reactions, respectively
  2. Total score
  3. Likelihood that the adverse reaction was drug related
  4. ≥ 9 = highly probable
  5. 5–8 = probable
  6. 1–4 = possible
  7. ≤ 0 = doubtful