Table 8

Adverse events

Outcome or subgroupStudiesPatientsEffect estimate(95% CI), heterogeneity (I2)
Serious adverse events72179RR 0.82 (0.62 to 1.08), 4%*
Subgroup: abarelix 100 mg31102RR 0.88 (0.60 to 1.28), 0%*
Subgroup: degarelix 240/160 mg1302RR 0.85 (0.46 to 1.57), NA*
Subgroup: degarelix 240/80 mg4775RR 0.68 (0.39 to 1.19), 35%*
Severe/life-threatening adverse event52064RR 0.76 (0.58 to 1.00), 4%*
Subgroup: abarelix 100 mg41454RR 0.79 (0.60 to 1.05), 0%*
Subgroup: degarelix 240/80 mg1308RR 0.16 (0.02 to 1.54), NA*
Subgroup: degarelix 240/160 mg1302RR 0.50 (0.07 to 3.46), NA*
Discontinuation due to adverse events82290RR 0.86 (0.57 to 1.31), 25%*
Subgroup: abarelix 100 mg31110RR 0.58 (0.31 to 1.08), 39%*
Subgroup: degarelix 240/80 mg5872RR 0.95 (0.44 to 2.04), 0%*
Subgroup: degarelix 240/160 mg1308RR 1.57 (0.65 to 3.81), NA*
Fatigue103784RR 0.88 (0.72 to 1.08), 0%*
Subgroup: abarelix 100 mg41456RR 0.96 (0.73 to 1.26), 0%*
Subgroup: degarelix 240/80 mg and 240/160 mg62328RR 0.80 (0.59 to 1.08), NA*
Hot flush83264RR 1.00 (0.92 to 1.08), 0%*
Subgroup: abarelix 100 mg2936RR 1.01 (0.93 to 1.10), 0%*
Subgroup: degarelix 240/80 mg and 240/160 mg62328RR 0.99 (0.88 to 1.11), NA*
Infection (abarelix 100 mg)2520RR 0.93 (0.42 to 2.05), NA*
Urinary tract infection82848RR 0.71 (0.41 to 1.25), 54%†
Subgroup: abarelix 100 mg2520RR 1.03 (0.52 to 2.07), NA†
Subgroup: degarelix 240/80 and 240/160 mg62328RR 0.57 (0.39 to 0.83), NA†
Loss of sexual interest2597RR 1.05 (0.38 to 2.91), 0%*
Subgroup: abarelix 100 mg1352RR 1.00 (0.06 to 15.86), NA*
Subgroup: degarelix 240/80 mg1245RR 1.06 (0.35 to 3.17), NA*
Sexual dysfunction (degarelix 240/80 mg)2427RR 0.83 (0.40 to 1.71), 0%*
Acute myocardial infarction1610RR 0.49 (0.07 to 3.48), 0%*
Subgroup: degarelix 240/160 mg1302RR 1.49 (0.06 to 36.31), NA*
Subgroup: degarelix 240/80 mg1308RR 0.16 (0.01 to 3.98), NA*
Cardiovascular events (degarelix 240/80 and 240/160 mg)62328RR 0.60 (0.38 to 0.94), NA‡
Ischaemic heart disease1610RR 0.42 (0.23 to 0.77), 0%*
Subgroup: degarelix 240/160 mg1302RR 0.50 (0.21 to 1.15), NA*
Subgroup: degarelix 240/80 mg1308RR 0.35 (0.15 to 0.85), NA*
Fatal cerebrovascular-related events (degarelix 240/80 mg and 240/160 mg)1610RR 0.49 (0.12 to 1.94), NA*
Asthenia (degarelix 240/80 mg)2427RR 0.91 (0.39 to 2.13), 0%*
Urinary retention41077RR 0.39 (0.12 to 1.32), 0%*
Subgroup: degarelix 240/160 mg1302RR 0.99 (0.09 to 10.79), NA*
Subgroup: degarelix 240/80 mg4775RR 0.28 (0.06 to 1.23), 0%*
Immediate onset allergic reactions (<1 h) (abarelix 100 mg)51694RR 2.36 (0.55 to 10.12), 0%*
Injection-site pain degarelix 240/80 mg and 240/160 mg62328RR 7.88 (5.65 to 10.98), NA*
Injection-site reaction (degarelix 240/80 mg and 240/160 mg)1610RR 79.61 (11.23 to 564.49), NA*
Diarrhoea (abarelix 100 mg)3872RR 1.21 (0.81 to 1.80), 0%*
Peripheral oedema (abarelix 100 mg)2520RR 0.51 (0.32 to 0.81), NA*
Constipation51522RR 0.99 (0.64 to 1.53), 0%*
Subgroup: abarelix 100 mg3872RR 1.00 (0.58 to 1.75), 0%*
Subgroup: degarelix 240/160 mg1303RR 0.60 (0.19 to 1.92), NA*
Subgroup: degarelix 240/80 mg2347RR 1.28 (0.49 to 3.33), 0%*
Arthralgia72680RR 0.64 (0.45 to 0.91), 0%*
Subgroup: abarelix 100 mg1352RR 0.40 (0.08 to 2.03), NA*
Subgroup: degarelix 240/80 mg and 240/160 mg62328RR 0.66 (0.46 to 0.94), NA*
Musculoskeletal adverse events (degarelix 240/80 mg)1408RR 0.65 (0.45 to 0.96), NA*
Chills1610RR 9.38 (1.26 to 69.58), 0%*
Subgroup: degarelix 240/80 mg1308RR 11.28 (0.67 to 189.51), NA*
Subgroup: degarelix 240/160 mg1302RR 7.46 (0.43 to 129.37), NA*
Back pain93200RR 0.74 (0.56 to 0.97), 4%*
Subgroup: abarelix 100 mg3872RR 0.81 (0.54 to 1.23), 38%*
Subgroup: degarelix 240/80 mg and 240/160 mg62328RR 0.68 (0.48 to 0.99), NA*

  • *Statistical method: Mantel-Haenszel, fixed-effect model.

  • †Statistical method: Mantel-Haenszel, random-effects model.

  • ‡Statistical method: Generic inverse variance, fixed-effect model.

  • MD, mean difference; NA, not applicable; RR, risk ratio.