Table 2

Summary of safety including incidence of most frequent (≥3% in any treatment group) adverse events

Placebo+NSAID*
(n=539)
Tanezumab
5 mg
(n=541)
Tanezumab
10 mg
(n=542)
Tanezumab
5 mg+NSAID*
(n=536)
Tanezumab
10 mg+NSAID*
(n=542)
Any adverse event, n (%)364 (67.5)405 (74.9)399 (73.6)390 (72.8)400 (73.8)
Any serious adverse event, n (%)43 (8.0)44 (8.1)46 (8.5)54 (10.1)64 (11.8)
Any withdrawal due to adverse event, n (%)49 (9.1)65 (12.0)86 (15.9)77 (14.4)99 (18.3)
Most frequent adverse events, n (%)
Gastrointestinal disorders
 Diarrhoea12 (2.2)15 (2.8)11 (2.0)19 (3.5)16 (3.0)
General disorders and administrative site conditions
 Peripheral oedema12 (2.2)33 (6.1)27 (5.0)38 (7.1)50 (9.2)
Infections and infestations
 Influenza16 (3.0)16 (3.0)16 (3.0)10 (1.9)10 (1.8)
 Nasopharyngitis23 (4.3)22 (4.1)19 (3.5)30 (5.6)21 (3.9)
 Sinusitis21 (3.9)14 (2.6)12 (2.2)11 (2.1)10 (1.8)
 Upper respiratory tract infection30 (5.6)22 (4.1)19 (3.5)22 (4.1)24 (4.4)
 Urinary tract infection30 (5.6)31 (5.7)27 (5.0)25 (4.7)24 (4.4)
Injury, poisoning and procedural complication
 Fall16 (3.0)18 (3.3)20 (3.7)25 (4.7)25 (4.6)
Investigations
 Blood creatine phosphokinase increased14 (2.6)13 (2.4)15 (2.8)18 (3.4)12 (2.2)
Musculoskeletal and connective tissue disorders
 Arthralgia48 (8.9)72 (13.3)89 (16.4)73 (13.6)61 (11.3)
 Back pain20 (3.7)31 (5.7)22 (4.1)21 (3.9)24 (4.4)
 Joint swelling7 (1.3)22 (4.1)27 (5.0)18 (3.4)17 (3.1)
 Muscle spasms10 (1.9)14 (2.6)8 (1.5)16 (3.0)12 (2.2)
 Musculoskeletal pain17 (3.2)16 (3.0)17 (3.1)20 (3.7)15 (2.8)
 Osteoarthritis28 (5.2)31 (5.7)37 (6.8)45 (8.4)37 (6.8)
 Pain in extremity18 (3.3)19 (3.5)36 (6.6)21 (3.9)30 (5.5)
Nervous system disorders, n (%)
 Carpal tunnel syndrome4 (0.7)9 (1.7)23 (4.2)11 (2.1)11 (2.0)
 Dizziness12 (2.2)17 (3.1)14 (2.6)16 (3.0)11 (2.0)
 Headache21 (3.9)30 (5.5)31 (5.7)22 (4.1)16 (3.0)
 Hypoesthesia14 (2.6)25 (4.6)31 (5.7)35 (6.5)35 (6.5)
 Paraesthesia17 (3.2)33 (6.1)39 (7.2)48 (9.0)60 (11.1)
Vascular disorders, n (%)
 Hypertension22 (4.1)13 (2.4)16 (3.0)19 (3.5)13 (2.4)
  • *Naproxen 500 mg twice daily or celecoxib 100 mg twice daily.

  • NSAID, non-steroidal anti-inflammatory drug.