Time Frame |
Adverse events reported during Period 1 (Weeks 0 to 26) are presented by Period 1 treatment group. Adverse events reported during Period 2 (Weeks 26 to 78) are presented by Period 2 treatment arm (Arm 1 through Arm 5).
|
Adverse Event Reporting Description |
[Not Specified]
|
|
Arm/Group Title
|
ADA+MTX/PBO+MTX (Arm 1)
|
ADA+MTX/ADA+MTX (Arm 2)
|
ADA+MTX/OL ADA+MTX (Arm 3)
|
PBO+MTX/PBO+MTX (Arm 4)
|
PBO+MTX/OL ADA+MTX (Arm 5)
|
Period 1 ADA+MTX
|
Period 1 PBO+MTX
|
Arm/Group Description |
Blinded combination ADA+MTX therapy...
|
Blinded combination ADA+MTX therapy...
|
Blinded combination therapy during ...
|
Blinded MTX monotherapy during Peri...
|
Blinded MTX monotherapy during Peri...
|
Combination therapy with methotrexa...
|
Combination therapy with methotrexa...
|
Arm/Group Description |
Blinded combination ADA+MTX therapy during Period 1 and blinded MTX monotherapy during Period 2
|
Blinded combination ADA+MTX therapy during Period 1 and Period 2
|
Blinded combination therapy during Period 1, open-label combination therapy during Period 2
|
Blinded MTX monotherapy during Period 1 and Period 2
|
Blinded MTX monotherapy during Period 1, open-label combination therapy during Period 2
|
Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1
|
Combination therapy with methotrexate (MTX) and blinded placebo (PBO) during Period 1
|
|
|
ADA+MTX/PBO+MTX (Arm 1)
|
ADA+MTX/ADA+MTX (Arm 2)
|
ADA+MTX/OL ADA+MTX (Arm 3)
|
PBO+MTX/PBO+MTX (Arm 4)
|
PBO+MTX/OL ADA+MTX (Arm 5)
|
Period 1 ADA+MTX
|
Period 1 PBO+MTX
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
--/-- |
--/-- |
--/-- |
--/-- |
--/-- |
--/-- |
--/-- |
|
|
ADA+MTX/PBO+MTX (Arm 1)
|
ADA+MTX/ADA+MTX (Arm 2)
|
ADA+MTX/OL ADA+MTX (Arm 3)
|
PBO+MTX/PBO+MTX (Arm 4)
|
PBO+MTX/OL ADA+MTX (Arm 5)
|
Period 1 ADA+MTX
|
Period 1 PBO+MTX
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
11/102 (10.78%) |
12/105 (11.43%) |
18/259 (6.95%) |
9/112 (8.04%) |
32/348 (9.20%) |
37/515 (7.18%) |
32/517 (6.19%) |
Cardiac disorders |
|
|
|
|
|
|
|
Acute myocardial infarction |
0/102 (0.00%) |
1/105 (0.95%) |
0/259 (0.00%) |
0/112 (0.00%) |
0/348 (0.00%) |
0/515 (0.00%) |
0/517 (0.00%) |
Angina unstable |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
0/348 (0.00%) |
0/515 (0.00%) |
1/517 (0.19%) |
Atrial fibrillation |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
0/348 (0.00%) |
1/515 (0.19%) |
1/517 (0.19%) |
Bradycardia |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
0/348 (0.00%) |
0/515 (0.00%) |
1/517 (0.19%) |
Cardiac failure |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
1/348 (0.29%) |
0/515 (0.00%) |
0/517 (0.00%) |
Cardiac failure congestive |
0/102 (0.00%) |
0/105 (0.00%) |
1/259 (0.39%) |
0/112 (0.00%) |
1/348 (0.29%) |
0/515 (0.00%) |
1/517 (0.19%) |
Coronary artery disease |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
1/348 (0.29%) |
2/515 (0.39%) |
0/517 (0.00%) |
Coronary artery insufficiency |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
0/348 (0.00%) |
0/515 (0.00%) |
1/517 (0.19%) |
Myocardial infarction |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
0/348 (0.00%) |
0/515 (0.00%) |
1/517 (0.19%) |
Right ventricular failure |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
0/348 (0.00%) |
1/515 (0.19%) |
0/517 (0.00%) |
Sinus bradycardia |
1/102 (0.98%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
0/348 (0.00%) |
0/515 (0.00%) |
0/517 (0.00%) |
Supraventricular tachycardia |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
0/348 (0.00%) |
0/515 (0.00%) |
1/517 (0.19%) |
Congenital, familial and genetic disorders |
|
|
|
|
|
|
|
Microgenia |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
1/348 (0.29%) |
0/515 (0.00%) |
0/517 (0.00%) |
Ear and labyrinth disorders |
|
|
|
|
|
|
|
Cerumen impaction |
0/102 (0.00%) |
0/105 (0.00%) |
1/259 (0.39%) |
0/112 (0.00%) |
0/348 (0.00%) |
0/515 (0.00%) |
0/517 (0.00%) |
Vertigo |
0/102 (0.00%) |
0/105 (0.00%) |
1/259 (0.39%) |
0/112 (0.00%) |
0/348 (0.00%) |
0/515 (0.00%) |
0/517 (0.00%) |
Eye disorders |
|
|
|
|
|
|
|
Cataract |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
0/348 (0.00%) |
1/515 (0.19%) |
0/517 (0.00%) |
Gastrointestinal disorders |
|
|
|
|
|
|
|
Abdominal hernia |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
1/112 (0.89%) |
0/348 (0.00%) |
0/515 (0.00%) |
0/517 (0.00%) |
Abdominal pain |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
0/348 (0.00%) |
1/515 (0.19%) |
0/517 (0.00%) |
Colitis ulcerative |
0/102 (0.00%) |
0/105 (0.00%) |
1/259 (0.39%) |
0/112 (0.00%) |
0/348 (0.00%) |
0/515 (0.00%) |
0/517 (0.00%) |
Diarrhoea |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
0/348 (0.00%) |
1/515 (0.19%) |
0/517 (0.00%) |
Duodenal ulcer |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
0/348 (0.00%) |
1/515 (0.19%) |
0/517 (0.00%) |
Gastric dilatation |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
0/348 (0.00%) |
1/515 (0.19%) |
0/517 (0.00%) |
Gastric ulcer |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
1/348 (0.29%) |
0/515 (0.00%) |
2/517 (0.39%) |
Gastritis haemorrhagic |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
1/348 (0.29%) |
0/515 (0.00%) |
0/517 (0.00%) |
Gastrointestinal haemorrhage |
1/102 (0.98%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
0/348 (0.00%) |
0/515 (0.00%) |
1/517 (0.19%) |
Haemorrhoids |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
1/112 (0.89%) |
0/348 (0.00%) |
0/515 (0.00%) |
0/517 (0.00%) |
Intestinal perforation |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
0/348 (0.00%) |
1/515 (0.19%) |
0/517 (0.00%) |
Nausea |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
0/348 (0.00%) |
1/515 (0.19%) |
0/517 (0.00%) |
Oedematous pancreatitis |
0/102 (0.00%) |
1/105 (0.95%) |
0/259 (0.00%) |
0/112 (0.00%) |
0/348 (0.00%) |
0/515 (0.00%) |
0/517 (0.00%) |
Oesophageal achalasia |
0/102 (0.00%) |
0/105 (0.00%) |
1/259 (0.39%) |
0/112 (0.00%) |
0/348 (0.00%) |
0/515 (0.00%) |
0/517 (0.00%) |
Oesophageal ulcer |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
0/348 (0.00%) |
1/515 (0.19%) |
0/517 (0.00%) |
Vomiting |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
0/348 (0.00%) |
1/515 (0.19%) |
0/517 (0.00%) |
General disorders |
|
|
|
|
|
|
|
Death |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
0/348 (0.00%) |
1/515 (0.19%) |
0/517 (0.00%) |
Drug intolerance |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
0/348 (0.00%) |
1/515 (0.19%) |
1/517 (0.19%) |
Medical device complication |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
0/348 (0.00%) |
1/515 (0.19%) |
0/517 (0.00%) |
Pyrexia |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
1/348 (0.29%) |
0/515 (0.00%) |
0/517 (0.00%) |
Sudden death |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
0/348 (0.00%) |
0/515 (0.00%) |
1/517 (0.19%) |
Hepatobiliary disorders |
|
|
|
|
|
|
|
Cholecystitis |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
1/112 (0.89%) |
0/348 (0.00%) |
0/515 (0.00%) |
1/517 (0.19%) |
Cholelithiasis |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
1/348 (0.29%) |
0/515 (0.00%) |
0/517 (0.00%) |
Ischaemic hepatitis |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
1/348 (0.29%) |
0/515 (0.00%) |
0/517 (0.00%) |
Infections and infestations |
|
|
|
|
|
|
|
Atypical mycobacterial infection |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
0/348 (0.00%) |
1/515 (0.19%) |
0/517 (0.00%) |
Bronchitis |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
1/112 (0.89%) |
0/348 (0.00%) |
0/515 (0.00%) |
0/517 (0.00%) |
Bronchopneumonia |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
1/348 (0.29%) |
0/515 (0.00%) |
0/517 (0.00%) |
Bronchopulmonary aspergillosis |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
1/348 (0.29%) |
0/515 (0.00%) |
0/517 (0.00%) |
Candida sepsis |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
1/348 (0.29%) |
0/515 (0.00%) |
0/517 (0.00%) |
Cellulitis |
0/102 (0.00%) |
1/105 (0.95%) |
0/259 (0.00%) |
0/112 (0.00%) |
0/348 (0.00%) |
2/515 (0.39%) |
1/517 (0.19%) |
Diverticulitis |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
1/348 (0.29%) |
0/515 (0.00%) |
0/517 (0.00%) |
Enterocolitis infectious |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
0/348 (0.00%) |
1/515 (0.19%) |
0/517 (0.00%) |
Erysipelas |
0/102 (0.00%) |
0/105 (0.00%) |
1/259 (0.39%) |
0/112 (0.00%) |
0/348 (0.00%) |
0/515 (0.00%) |
0/517 (0.00%) |
Gangrene |
0/102 (0.00%) |
0/105 (0.00%) |
1/259 (0.39%) |
0/112 (0.00%) |
0/348 (0.00%) |
0/515 (0.00%) |
0/517 (0.00%) |
Gastroenteritis |
1/102 (0.98%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
0/348 (0.00%) |
0/515 (0.00%) |
0/517 (0.00%) |
Herpes zoster |
1/102 (0.98%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
0/348 (0.00%) |
1/515 (0.19%) |
0/517 (0.00%) |
Infection |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
1/348 (0.29%) |
0/515 (0.00%) |
0/517 (0.00%) |
Influenza |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
1/112 (0.89%) |
0/348 (0.00%) |
0/515 (0.00%) |
0/517 (0.00%) |
Lobar pneumonia |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
1/348 (0.29%) |
0/515 (0.00%) |
0/517 (0.00%) |
Lower respiratory tract infection |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
0/348 (0.00%) |
0/515 (0.00%) |
1/517 (0.19%) |
Lower respiratory tract infection bacterial |
0/102 (0.00%) |
0/105 (0.00%) |
1/259 (0.39%) |
0/112 (0.00%) |
0/348 (0.00%) |
0/515 (0.00%) |
0/517 (0.00%) |
Orchitis |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
0/348 (0.00%) |
0/515 (0.00%) |
1/517 (0.19%) |
Osteomyelitis |
1/102 (0.98%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
0/348 (0.00%) |
0/515 (0.00%) |
0/517 (0.00%) |
Peritoneal tuberculosis |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
0/348 (0.00%) |
1/515 (0.19%) |
0/517 (0.00%) |
Pharyngitis |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
0/348 (0.00%) |
1/515 (0.19%) |
0/517 (0.00%) |
Pneumonia |
1/102 (0.98%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
2/348 (0.57%) |
4/515 (0.78%) |
1/517 (0.19%) |
Pneumonia bacterial |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
0/348 (0.00%) |
1/515 (0.19%) |
0/517 (0.00%) |
Pneumonia legionella |
0/102 (0.00%) |
0/105 (0.00%) |
1/259 (0.39%) |
0/112 (0.00%) |
1/348 (0.29%) |
0/515 (0.00%) |
0/517 (0.00%) |
Pulmonary tuberculosis |
1/102 (0.98%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
2/348 (0.57%) |
0/515 (0.00%) |
0/517 (0.00%) |
Respiratory tract infection |
0/102 (0.00%) |
1/105 (0.95%) |
0/259 (0.00%) |
0/112 (0.00%) |
0/348 (0.00%) |
0/515 (0.00%) |
1/517 (0.19%) |
Sepsis |
0/102 (0.00%) |
1/105 (0.95%) |
0/259 (0.00%) |
0/112 (0.00%) |
0/348 (0.00%) |
0/515 (0.00%) |
0/517 (0.00%) |
Sinusitis |
0/102 (0.00%) |
0/105 (0.00%) |
1/259 (0.39%) |
0/112 (0.00%) |
0/348 (0.00%) |
0/515 (0.00%) |
0/517 (0.00%) |
Staphylococcal abscess |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
0/348 (0.00%) |
1/515 (0.19%) |
0/517 (0.00%) |
Staphylococcal infection |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
0/348 (0.00%) |
0/515 (0.00%) |
1/517 (0.19%) |
Staphylococcal sepsis |
0/102 (0.00%) |
1/105 (0.95%) |
0/259 (0.00%) |
0/112 (0.00%) |
0/348 (0.00%) |
0/515 (0.00%) |
0/517 (0.00%) |
Urinary tract infection |
0/102 (0.00%) |
1/105 (0.95%) |
0/259 (0.00%) |
0/112 (0.00%) |
0/348 (0.00%) |
0/515 (0.00%) |
0/517 (0.00%) |
Viral infection |
0/102 (0.00%) |
1/105 (0.95%) |
0/259 (0.00%) |
0/112 (0.00%) |
0/348 (0.00%) |
0/515 (0.00%) |
0/517 (0.00%) |
Vulvovaginitis |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
0/348 (0.00%) |
1/515 (0.19%) |
0/517 (0.00%) |
Injury, poisoning and procedural complications |
|
|
|
|
|
|
|
Femur fracture |
0/102 (0.00%) |
1/105 (0.95%) |
0/259 (0.00%) |
0/112 (0.00%) |
0/348 (0.00%) |
1/515 (0.19%) |
0/517 (0.00%) |
Forearm fracture |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
0/348 (0.00%) |
1/515 (0.19%) |
0/517 (0.00%) |
Hip fracture |
0/102 (0.00%) |
1/105 (0.95%) |
0/259 (0.00%) |
0/112 (0.00%) |
0/348 (0.00%) |
1/515 (0.19%) |
0/517 (0.00%) |
Intentional overdose |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
0/348 (0.00%) |
0/515 (0.00%) |
1/517 (0.19%) |
Kidney rupture |
1/102 (0.98%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
0/348 (0.00%) |
0/515 (0.00%) |
0/517 (0.00%) |
Overdose |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
0/348 (0.00%) |
0/515 (0.00%) |
1/517 (0.19%) |
Rib fracture |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
0/348 (0.00%) |
1/515 (0.19%) |
0/517 (0.00%) |
Thoracic vertebral fracture |
1/102 (0.98%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
0/348 (0.00%) |
0/515 (0.00%) |
0/517 (0.00%) |
Upper limb fracture |
0/102 (0.00%) |
0/105 (0.00%) |
1/259 (0.39%) |
0/112 (0.00%) |
0/348 (0.00%) |
0/515 (0.00%) |
0/517 (0.00%) |
Vaccination complication |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
1/348 (0.29%) |
0/515 (0.00%) |
0/517 (0.00%) |
Wrist fracture |
1/102 (0.98%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
1/348 (0.29%) |
0/515 (0.00%) |
0/517 (0.00%) |
Metabolism and nutrition disorders |
|
|
|
|
|
|
|
Gout |
0/102 (0.00%) |
0/105 (0.00%) |
1/259 (0.39%) |
0/112 (0.00%) |
0/348 (0.00%) |
0/515 (0.00%) |
0/517 (0.00%) |
Hypoglycaemia |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
1/348 (0.29%) |
0/515 (0.00%) |
0/517 (0.00%) |
Malnutrition |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
0/348 (0.00%) |
0/515 (0.00%) |
1/517 (0.19%) |
Musculoskeletal and connective tissue disorders |
|
|
|
|
|
|
|
Arthralgia |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
0/348 (0.00%) |
1/515 (0.19%) |
1/517 (0.19%) |
Back pain |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
0/348 (0.00%) |
1/515 (0.19%) |
0/517 (0.00%) |
Intervertebral disc protrusion |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
0/348 (0.00%) |
1/515 (0.19%) |
1/517 (0.19%) |
Knee deformity |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
1/348 (0.29%) |
0/515 (0.00%) |
0/517 (0.00%) |
Monarthritis |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
0/348 (0.00%) |
1/515 (0.19%) |
0/517 (0.00%) |
Osteoarthritis |
0/102 (0.00%) |
0/105 (0.00%) |
1/259 (0.39%) |
0/112 (0.00%) |
1/348 (0.29%) |
0/515 (0.00%) |
2/517 (0.39%) |
Osteoporotic fracture |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
1/112 (0.89%) |
0/348 (0.00%) |
0/515 (0.00%) |
0/517 (0.00%) |
Polyarthritis |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
0/348 (0.00%) |
1/515 (0.19%) |
0/517 (0.00%) |
Rheumatoid arthritis |
0/102 (0.00%) |
0/105 (0.00%) |
1/259 (0.39%) |
0/112 (0.00%) |
4/348 (1.15%) |
1/515 (0.19%) |
2/517 (0.39%) |
Synovitis |
0/102 (0.00%) |
1/105 (0.95%) |
0/259 (0.00%) |
0/112 (0.00%) |
0/348 (0.00%) |
0/515 (0.00%) |
0/517 (0.00%) |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
|
|
|
|
|
|
Basal cell carcinoma |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
2/348 (0.57%) |
0/515 (0.00%) |
0/517 (0.00%) |
Benign mediastinal neoplasm |
1/102 (0.98%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
0/348 (0.00%) |
0/515 (0.00%) |
0/517 (0.00%) |
Bile duct cancer |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
1/112 (0.89%) |
0/348 (0.00%) |
0/515 (0.00%) |
0/517 (0.00%) |
Breast cancer |
0/102 (0.00%) |
0/105 (0.00%) |
2/259 (0.77%) |
1/112 (0.89%) |
1/348 (0.29%) |
0/515 (0.00%) |
0/517 (0.00%) |
Lung neoplasm malignant |
0/102 (0.00%) |
0/105 (0.00%) |
1/259 (0.39%) |
0/112 (0.00%) |
1/348 (0.29%) |
0/515 (0.00%) |
0/517 (0.00%) |
Oesophageal squamous cell carcinoma |
1/102 (0.98%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
0/348 (0.00%) |
0/515 (0.00%) |
0/517 (0.00%) |
Nervous system disorders |
|
|
|
|
|
|
|
Carotid artery aneurysm |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
0/348 (0.00%) |
0/515 (0.00%) |
1/517 (0.19%) |
Cerebrovascular accident |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
0/348 (0.00%) |
1/515 (0.19%) |
0/517 (0.00%) |
Dizziness |
1/102 (0.98%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
0/348 (0.00%) |
0/515 (0.00%) |
0/517 (0.00%) |
Facial palsy |
0/102 (0.00%) |
0/105 (0.00%) |
1/259 (0.39%) |
0/112 (0.00%) |
0/348 (0.00%) |
0/515 (0.00%) |
0/517 (0.00%) |
Headache |
1/102 (0.98%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
0/348 (0.00%) |
0/515 (0.00%) |
0/517 (0.00%) |
Syncope |
0/102 (0.00%) |
0/105 (0.00%) |
1/259 (0.39%) |
0/112 (0.00%) |
0/348 (0.00%) |
1/515 (0.19%) |
1/517 (0.19%) |
Pregnancy, puerperium and perinatal conditions |
|
|
|
|
|
|
|
Abortion spontaneous |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
0/348 (0.00%) |
0/515 (0.00%) |
1/517 (0.19%) |
Psychiatric disorders |
|
|
|
|
|
|
|
Acute stress disorder |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
1/348 (0.29%) |
0/515 (0.00%) |
0/517 (0.00%) |
Confusional state |
0/102 (0.00%) |
0/105 (0.00%) |
1/259 (0.39%) |
0/112 (0.00%) |
0/348 (0.00%) |
0/515 (0.00%) |
0/517 (0.00%) |
Suicide attempt |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
0/348 (0.00%) |
0/515 (0.00%) |
1/517 (0.19%) |
Renal and urinary disorders |
|
|
|
|
|
|
|
Nephrolithiasis |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
0/348 (0.00%) |
0/515 (0.00%) |
1/517 (0.19%) |
Renal failure acute |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
1/348 (0.29%) |
0/515 (0.00%) |
0/517 (0.00%) |
Ureteric obstruction |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
0/348 (0.00%) |
0/515 (0.00%) |
1/517 (0.19%) |
Reproductive system and breast disorders |
|
|
|
|
|
|
|
Benign prostatic hyperplasia |
0/102 (0.00%) |
2/105 (1.90%) |
0/259 (0.00%) |
0/112 (0.00%) |
0/348 (0.00%) |
0/515 (0.00%) |
0/517 (0.00%) |
Cervical dysplasia |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
0/348 (0.00%) |
0/515 (0.00%) |
1/517 (0.19%) |
Metrorrhagia |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
0/348 (0.00%) |
1/515 (0.19%) |
0/517 (0.00%) |
Micromastia |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
0/348 (0.00%) |
0/515 (0.00%) |
1/517 (0.19%) |
Prostatitis |
0/102 (0.00%) |
1/105 (0.95%) |
0/259 (0.00%) |
0/112 (0.00%) |
0/348 (0.00%) |
0/515 (0.00%) |
0/517 (0.00%) |
Uterine prolapse |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
0/348 (0.00%) |
0/515 (0.00%) |
1/517 (0.19%) |
Respiratory, thoracic and mediastinal disorders |
|
|
|
|
|
|
|
Acute respiratory distress syndrome |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
0/348 (0.00%) |
1/515 (0.19%) |
0/517 (0.00%) |
Alveolitis allergic |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
0/348 (0.00%) |
2/515 (0.39%) |
0/517 (0.00%) |
Asthma |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
0/348 (0.00%) |
0/515 (0.00%) |
1/517 (0.19%) |
Chronic obstructive pulmonary disease |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
0/348 (0.00%) |
0/515 (0.00%) |
1/517 (0.19%) |
Emphysema |
0/102 (0.00%) |
0/105 (0.00%) |
1/259 (0.39%) |
0/112 (0.00%) |
0/348 (0.00%) |
0/515 (0.00%) |
0/517 (0.00%) |
Haemothorax |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
0/348 (0.00%) |
1/515 (0.19%) |
0/517 (0.00%) |
Interstitial lung disease |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
2/348 (0.57%) |
2/515 (0.39%) |
0/517 (0.00%) |
Pleural effusion |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
0/348 (0.00%) |
1/515 (0.19%) |
0/517 (0.00%) |
Pneumonitis |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
0/348 (0.00%) |
2/515 (0.39%) |
1/517 (0.19%) |
Pulmonary embolism |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
1/112 (0.89%) |
0/348 (0.00%) |
0/515 (0.00%) |
0/517 (0.00%) |
Pulmonary fibrosis |
0/102 (0.00%) |
1/105 (0.95%) |
0/259 (0.00%) |
0/112 (0.00%) |
0/348 (0.00%) |
0/515 (0.00%) |
0/517 (0.00%) |
Respiratory failure |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
1/348 (0.29%) |
0/515 (0.00%) |
1/517 (0.19%) |
Skin and subcutaneous tissue disorders |
|
|
|
|
|
|
|
Dermatitis allergic |
0/102 (0.00%) |
0/105 (0.00%) |
1/259 (0.39%) |
0/112 (0.00%) |
0/348 (0.00%) |
0/515 (0.00%) |
0/517 (0.00%) |
Social circumstances |
|
|
|
|
|
|
|
Physical abuse |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
1/348 (0.29%) |
0/515 (0.00%) |
0/517 (0.00%) |
Surgical and medical procedures |
|
|
|
|
|
|
|
Abortion induced |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
1/112 (0.89%) |
0/348 (0.00%) |
0/515 (0.00%) |
0/517 (0.00%) |
Vascular disorders |
|
|
|
|
|
|
|
Aortic stenosis |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
0/348 (0.00%) |
0/515 (0.00%) |
1/517 (0.19%) |
Deep vein thrombosis |
0/102 (0.00%) |
0/105 (0.00%) |
1/259 (0.39%) |
0/112 (0.00%) |
0/348 (0.00%) |
0/515 (0.00%) |
0/517 (0.00%) |
Hypertension |
0/102 (0.00%) |
0/105 (0.00%) |
1/259 (0.39%) |
0/112 (0.00%) |
0/348 (0.00%) |
0/515 (0.00%) |
0/517 (0.00%) |
Thrombophlebitis superficial |
0/102 (0.00%) |
0/105 (0.00%) |
0/259 (0.00%) |
0/112 (0.00%) |
0/348 (0.00%) |
0/515 (0.00%) |
1/517 (0.19%) |
Indicates events were collected by non-systematic assessment
Term from vocabulary, MedDRA 13.0
Adverse event resulted in death of subject
Adverse event resulted in death of 1 subject in Arm 5
Adverse event resulted in death of subject, who also had a fatal adverse event of confusional state (cause of death possibly cerebrovascular accident)
Adverse event resulted in death of subject, who also had a fatal adverse event of facial palsy (cause of death possibly cerebrovascular accident)
Adverse event resulted in death of 2 subjects in ADA+MTX group during Period 1
|
|
Frequency Threshold for Reporting Other Adverse Events
|
5%
|
|
ADA+MTX/PBO+MTX (Arm 1)
|
ADA+MTX/ADA+MTX (Arm 2)
|
ADA+MTX/OL ADA+MTX (Arm 3)
|
PBO+MTX/PBO+MTX (Arm 4)
|
PBO+MTX/OL ADA+MTX (Arm 5)
|
Period 1 ADA+MTX
|
Period 1 PBO+MTX
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
28/102 (27.45%) |
38/105 (36.19%) |
106/259 (40.93%) |
44/112 (39.29%) |
134/348 (38.51%) |
149/515 (28.93%) |
128/517 (24.76%) |
Gastrointestinal disorders |
|
|
|
|
|
|
|
Diarrhoea |
1/102 (0.98%) |
1/105 (0.95%) |
10/259 (3.86%) |
1/112 (0.89%) |
15/348 (4.31%) |
23/515 (4.47%) |
27/517 (5.22%) |
Nausea |
7/102 (6.86%) |
4/105 (3.81%) |
15/259 (5.79%) |
9/112 (8.04%) |
27/348 (7.76%) |
60/515 (11.65%) |
55/517 (10.64%) |
Infections and infestations |
|
|
|
|
|
|
|
Bronchitis |
3/102 (2.94%) |
2/105 (1.90%) |
14/259 (5.41%) |
6/112 (5.36%) |
19/348 (5.46%) |
16/515 (3.11%) |
20/517 (3.87%) |
Influenza |
3/102 (2.94%) |
6/105 (5.71%) |
9/259 (3.47%) |
3/112 (2.68%) |
11/348 (3.16%) |
22/515 (4.27%) |
12/517 (2.32%) |
Nasopharyngitis |
5/102 (4.90%) |
6/105 (5.71%) |
23/259 (8.88%) |
4/112 (3.57%) |
23/348 (6.61%) |
34/515 (6.60%) |
25/517 (4.84%) |
Sinusitis |
3/102 (2.94%) |
2/105 (1.90%) |
9/259 (3.47%) |
8/112 (7.14%) |
19/348 (5.46%) |
13/515 (2.52%) |
15/517 (2.90%) |
Upper respiratory tract infection |
5/102 (4.90%) |
5/105 (4.76%) |
29/259 (11.20%) |
7/112 (6.25%) |
27/348 (7.76%) |
35/515 (6.80%) |
38/517 (7.35%) |
Urinary tract infection |
2/102 (1.96%) |
5/105 (4.76%) |
12/259 (4.63%) |
5/112 (4.46%) |
22/348 (6.32%) |
25/515 (4.85%) |
22/517 (4.26%) |
Investigations |
|
|
|
|
|
|
|
Alanine aminotransferase increased |
5/102 (4.90%) |
4/105 (3.81%) |
16/259 (6.18%) |
3/112 (2.68%) |
16/348 (4.60%) |
11/515 (2.14%) |
14/517 (2.71%) |
Nervous system disorders |
|
|
|
|
|
|
|
Headache |
2/102 (1.96%) |
3/105 (2.86%) |
9/259 (3.47%) |
2/112 (1.79%) |
10/348 (2.87%) |
26/515 (5.05%) |
24/517 (4.64%) |
Respiratory, thoracic and mediastinal disorders |
|
|
|
|
|
|
|
Cough |
3/102 (2.94%) |
7/105 (6.67%) |
13/259 (5.02%) |
4/112 (3.57%) |
14/348 (4.02%) |
20/515 (3.88%) |
18/517 (3.48%) |
Vascular disorders |
|
|
|
|
|
|
|
Hypertension |
1/102 (0.98%) |
5/105 (4.76%) |
6/259 (2.32%) |
6/112 (5.36%) |
7/348 (2.01%) |
18/515 (3.50%) |
19/517 (3.68%) |
Indicates events were collected by non-systematic assessment
Term from vocabulary, MedDRA 13.0
|