Table 4

More AESI in prednisolone patients; safety population

Prednisolone (n=224)Placebo (n=225)
Number of patients with at least one AESI *134 (60%)111 (49%)
 SAE only2525
 Other AESI only7965
 SAE and other AESI3021
By organ class (per 100 person-years) †SAEOther
 Cardiac disorders‡
 Eye disorders0.
 Gastrointestinal disorders1.
 Infections and infestations§7.335.04.525.6
 Injury, poisoning and procedural complications0.
 Neoplasms benign, malignant and unspecified (incl cysts and polyps)¶
 Nervous system disorders2.
 Respiratory, thoracic and mediastinal disorders2.
By protocol-defined category
 Urinary tract449429
 Symptomatic fracture**21146
 New onset
 Diabetes mellitus02††01††
  • * Adjusted relative risk: 1.24, one-sided 95% bound 1.04, one-sided p: 0.02; number needed to harm: 9.5.

  • † In case of multiple organ class codings, the most important class was chosen from the description of the event.

  • ‡ Two deaths in placebo group on treatment (atrioventricular block, cardiac insufficiency). The protocol-defined category ‘Cardiovascular’ comprised myocardial infarction, cerebrovascular event, peripheral arterial vascular event.

  • §One death in prednisolone group on treatment (septic shock); another case excluded that occurred outside the assessment window of 3 months. This patient with septicemia was discharged alive and later reported (and initially included) as death with unknown date. Date of death was retrieved after database closure and found to be 5 months after discontinuation. The death of this patient was not counted in the primary analysis.

  • ¶Two deaths in prednisolone group (both, stage 4 pulmonary carcinoma; 1 respectively 2.5 months after premature discontinuation).

  • **See also table 5, bone health.

  • †† One patient in each group had a history of hyperglycemia.

  • ‡‡ One patient admitted twice for cataract surgery, thus both classified as SAE.

  • §§ ‘Other’ SAE: events in other organ classes. ‘Other’ other AESI: non-serious AE outside of the above predefined categories, but associated with premature discontinuation.

  • AESI, adverse event of special interest; comprises serious adverse events (SAE) and 'other AESI'.