TABLE 2.
Characteristics of disorders and drugs screened by the Junior Adverse Event Manager team
| A. Disorders by organ class (MedDRA classification) | Screened | Reported | Number needed to screen to report 1 ADR |
|---|---|---|---|
| General disorders and administration site conditions | 30 | 12 | 2 .5 |
| Nervous system disorders | 55 | 14 | 3.9 |
| Gastrointestinal disorders | 133 | 13 | 10.2 |
| Skin and subcutaneous tissue disorders | 12 | 4 | 3.0 |
| Respiratory, thoracic and mediastinal disorders | 62 | 6 | 10.3 |
| Psychiatric disorders | 72 | 18 | 4.0 |
| Musculoskeletal and connective tissue disorders | 32 | 4 | 8.0 |
| Blood and lymphatic system disorders | 211 | 16 | 13.2 |
| Eye disorders | 3 | 0 | ‐ |
| Ear, nose and throat disorders | 62 | 0 | ‐ |
| Renal and urinary disorders | 58 | 11 | 5.3 |
| Vascular disorders | 23 | 3 | 7.7 |
| Total | 753 | 101 | 7.5 |
| B. Type of drug (ATC classification) | Screened | Reported | Number needed to screen to report 1 ADR |
|---|---|---|---|
| A. Gastrointestinal | 591 | 10 | 59.1 |
| B. Blood and lymphatic | 101 | 8 | 12.6 |
| C. Cardiovascular | 496 | 41 | 12.1 |
| D. Skin and subcutaneous tissue | 62 | 0 | ‐ |
| G. Renal and urinary | 43 | 2 | 21.5 |
| H. Hormones | 121 | 5 | 24.2 |
| J. Antibiotics and antiparasitics | 215 | 14 | 15.4 |
| L. Immunomodulatory and chemotherapeutics | 16 | 4 | 4.0 |
| M. Musculoskeletal and connective tissue | 72 | 2 | 36.0 |
| N. Nervous system and senses | 215 | 12 | 17.9 |
| R. Pulmonary drugs | 171 | 2 | 85.5 |
| V. Over‐the‐counter drugs | 283 | 1 | 283 |
| Total | 2386 | 101 | 23.6 |
2A: Overview of the number of disorders screened (according to MedDRA classification), the number of reports per disorder and the reporting chance. 2B: Overview of the number of drugs screened (according to ATC classification), the number of reports per drug class and the reporting chance.