Table 3.

Patients with reported pulmonary abnormalities.

PatientAdverse Event RecordedSupporting InvestigationsSeverity Grade*Causality** MTX or LEF
1Pleural effusionCT, PFT4Unrelated
2Interstitial lung diseaseCT, PFT2LEF unrelated, MTX possible
3Fibrosing alveolitisCT, PFT2Unrelated
4Pulmonary infiltrateCT, PFT, bronchoscopy, biopsy3MTX probable, LEF unrelated
5Interstitial lung diseaseCT3LEF unrelated, MTX possible
6Fibrosing alveolitisNone3LEF unrelated, MTX unlikely
7PneumoniaCT2MTX possible, LEF unrelated
8Interstitial lung diseaseCT2Unrelated

  • ↵* According to the Common Terminology Criteria for Adverse Events7.

  • ↵** Relationship to study drug. CT: computed tomography; PFT: pulmonary function tests; MTX: methotrexate; LEF: leflunomide.