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 only | 25 | 25 | ||
| Other AESI only | 79 | 65 | ||
| SAE and other AESI | 30 | 21 | ||
| By organ class (per 100 person-years) † | SAE | Other AESI |
SAE | Other AESI |
| Cardiac disorders‡ | 1.7 | 0.0 | 2.2 | 0.0 |
| Eye disorders | 0.0 | 3.1 | 0.6 | 2.0 |
| Gastrointestinal disorders | 1.7 | 1.7 | 0.6 | 2.0 |
| Infections and infestations§ | 7.3 | 35.0 | 4.5 | 25.6 |
| Injury, poisoning and procedural complications | 0.8 | 4.0 | 1.7 | 2.2 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps)¶ | 2.5 | 1.1 | 2.0 | 0.3 |
| Nervous system disorders | 2.0 | 0.0 | 2.5 | 0.3 |
| Respiratory, thoracic and mediastinal disorders | 2.0 | 2.5 | 0.8 | 0.6 |
| Other | 4.5 | 2.3 | 2.8 | 1.4 |
| Total | 23 | 55 | 18 | 39 |
| By protocol-defined category | ||||
| Infection | 26 | 124 | 16 | 91 |
| Urinary tract | 4 | 49 | 4 | 29 |
| Pneumonia | 2 | 17 | 2 | 13 |
| Other | 20 | 58 | 10 | 49 |
| Cardiovascular‡ | 8 | 2 | 6 | 0 |
| Symptomatic fracture** | 2 | 11 | 4 | 6 |
| New onset | ||||
| Hypertension | 1 | 4 | 0 | 7 |
| Diabetes mellitus | 0 | 2†† | 0 | 1†† |
| Cataract | 0 | 7 | 2‡‡ | 6 |
| Glaucoma | 0 | 1 | 0 | 3 |
| Other§§ | 43 | 43 | 35 | 26 |
| Total | 80 | 194 | 63 | 140 |
* 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'.