Table 4

Adverse events (AEs)

Description of eventOutcome at time of reporting AEsRelated to treatmentTime* (months)DMARDs†
Placebo group
Adverse reactions
 Admitted to hospital with severe abdominal painResolved completelyProbably1.4No
 HeadacheResolved completelyProbably0.07No
 NauseaResolved completelyProbably0.07No
Adverse events
 Developed lung cancerPatient diedProbably not3.2No
 Developed breast cancerResolved partiallyProbably not6.7Yes
 Anaphylactic shock due to ZantacResolved completelyNo4.9No
 Metastatic adenocarcinomaNot resolvedNo10.0Yes
 PancreatitisResolved completelyNo1.8No
 Pleural effusionResolved partiallyNo6.8Yes
 Carcinoma of sigmoid colonNot knownNo7.8Yes
 Carcinoma of prostateResolved partiallyNo8.8Yes
 Ischaemic heart diseasePatient diedNo2.8No
Glucocorticoid group
Adverse reactions
 Hospitalisation owing to severe reaction after injectionResolved completelyProbably1.0No
 Anaphylactic reactionResolved completelyProbably0.2No
 Cramp in calvesResolved partiallyProbably0.6No
 Sore legResolved completelyPossibly0.3No
 Mood swingsResolved completelyPossibly0.1No
 Fever and flu symptomsNAPossibly0.2No
Adverse events
 Raised ALT levelsResolved completelyPossibly9.5Yes
 Strangulated herniaPatient diedProbably not13.5Yes
 Rectal bleedingNot resolvedProbably not0.1No
 Intermittent crampNot resolvedProbably not0.3No
 RashResolved partiallyProbably not1.6No
 NauseaResolved completelyProbably not0.5No
 VomitingResolved completelyProbably not0.5No
 PneumoniaResolved completelyProbably not4.0No
 OverdoseResolved completelyNo4.2Yes
 Admitted to hospital owing to worsening arthritisNot resolvedNo0.7Yes
 Lower respiratory tract infectionResolved completelyNo11.1Yes
 GlycosuriaResolved completelyNo3.0No
 Chest infectionResolved completelyNo2.5No
 Infected sinusesResolved completelyNo3.5No
 ColdResolved completelyNo4.9No
 Urinary tract infectionNot resolvedNo0.07No
 Intermittent pain and needles right footNot resolvedNo6.0Yes
Raised ALT levelsNot resolvedNo5.5No
  • * Time between baseline visit and occurrence of adverse event; patient used disease-modifying antirheumatic drugs (DMARDs) at time of adverse event (yes or no).