Adverse events (AEs)
| Description of event | Outcome at time of reporting AEs | Related to treatment | Time* (months) | DMARDs† |
|---|---|---|---|---|
| Placebo group | ||||
| Adverse reactions | ||||
| Admitted to hospital with severe abdominal pain | Resolved completely | Probably | 1.4 | No |
| Headache | Resolved completely | Probably | 0.07 | No |
| Nausea | Resolved completely | Probably | 0.07 | No |
| Adverse events | ||||
| Developed lung cancer | Patient died | Probably not | 3.2 | No |
| Developed breast cancer | Resolved partially | Probably not | 6.7 | Yes |
| Anaphylactic shock due to Zantac | Resolved completely | No | 4.9 | No |
| Metastatic adenocarcinoma | Not resolved | No | 10.0 | Yes |
| Pancreatitis | Resolved completely | No | 1.8 | No |
| Pleural effusion | Resolved partially | No | 6.8 | Yes |
| Carcinoma of sigmoid colon | Not known | No | 7.8 | Yes |
| Carcinoma of prostate | Resolved partially | No | 8.8 | Yes |
| Ischaemic heart disease | Patient died | No | 2.8 | No |
| Glucocorticoid group | ||||
| Adverse reactions | ||||
| Hospitalisation owing to severe reaction after injection | Resolved completely | Probably | 1.0 | No |
| Anaphylactic reaction | Resolved completely | Probably | 0.2 | No |
| Cramp in calves | Resolved partially | Probably | 0.6 | No |
| Sore leg | Resolved completely | Possibly | 0.3 | No |
| Mood swings | Resolved completely | Possibly | 0.1 | No |
| Fever and flu symptoms | NA | Possibly | 0.2 | No |
| Adverse events | ||||
| Raised ALT levels | Resolved completely | Possibly | 9.5 | Yes |
| Strangulated hernia | Patient died | Probably not | 13.5 | Yes |
| Rectal bleeding | Not resolved | Probably not | 0.1 | No |
| Intermittent cramp | Not resolved | Probably not | 0.3 | No |
| Rash | Resolved partially | Probably not | 1.6 | No |
| Nausea | Resolved completely | Probably not | 0.5 | No |
| Vomiting | Resolved completely | Probably not | 0.5 | No |
| Pneumonia | Resolved completely | Probably not | 4.0 | No |
| Overdose | Resolved completely | No | 4.2 | Yes |
| Admitted to hospital owing to worsening arthritis | Not resolved | No | 0.7 | Yes |
| Lower respiratory tract infection | Resolved completely | No | 11.1 | Yes |
| Glycosuria | Resolved completely | No | 3.0 | No |
| Chest infection | Resolved completely | No | 2.5 | No |
| Infected sinuses | Resolved completely | No | 3.5 | No |
| Cold | Resolved completely | No | 4.9 | No |
| Urinary tract infection | Not resolved | No | 0.07 | No |
| Intermittent pain and needles right foot | Not resolved | No | 6.0 | Yes |
| Raised ALT levels | Not resolved | No | 5.5 | No |
↵* Time between baseline visit and occurrence of adverse event; patient used disease-modifying antirheumatic drugs (DMARDs) at time of adverse event (yes or no).