Time Frame |
Adverse events were collected from the first dose of study drug through 30 days after the last dose of study drug. Treatment was administered for up to 49 weeks.
|
Adverse Event Reporting Description |
Per protocol, all grades of peripheral neuropathy and skeletal events, Grade 3/4 AEs, and all SAEs were recorded. There may be grade 1 or 2 events that were not required to be collected.
|
|
Arm/Group Title
|
Bortezomib and Dexamethasone
|
Bortezomib, Thalidomide, and Dexamethasone
|
Bortezomib, Melphalan and Prednisone
|
Arm/Group Description |
Participants received bortezomib (V...
|
Participants received bortezomib 1....
|
Participants received bortezomib 1....
|
Arm/Group Description |
Participants received bortezomib (Velcade) 1.3 mg/m^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
|
Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
|
Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and melphalan 9 mg/m^2 orally on Days 1-4 every other cycle and prednisone 60 mg/m^2 orally on Days 1-4 every other cycle for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
|
|
|
Bortezomib and Dexamethasone
|
Bortezomib, Thalidomide, and Dexamethasone
|
Bortezomib, Melphalan and Prednisone
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
--/-- |
--/-- |
--/-- |
|
|
Bortezomib and Dexamethasone
|
Bortezomib, Thalidomide, and Dexamethasone
|
Bortezomib, Melphalan and Prednisone
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
88/165 (53.33%) |
92/158 (58.23%) |
83/163 (50.92%) |
Blood and lymphatic system disorders |
|
|
|
Anaemia |
4/165 (2.42%) |
6/158 (3.80%) |
2/163 (1.23%) |
Haemorrhagic anaemia |
0/165 (0.00%) |
0/158 (0.00%) |
1/163 (0.61%) |
Thrombocytopenia |
1/165 (0.61%) |
1/158 (0.63%) |
3/163 (1.84%) |
Pancytopenia |
0/165 (0.00%) |
0/158 (0.00%) |
3/163 (1.84%) |
Febrile neutropenia |
0/165 (0.00%) |
0/158 (0.00%) |
1/163 (0.61%) |
Neutropenia |
0/165 (0.00%) |
0/158 (0.00%) |
1/163 (0.61%) |
Coagulopathy |
1/165 (0.61%) |
0/158 (0.00%) |
0/163 (0.00%) |
Cardiac disorders |
|
|
|
Atrial fibrillation |
7/165 (4.24%) |
7/158 (4.43%) |
1/163 (0.61%) |
Atrial flutter |
3/165 (1.82%) |
1/158 (0.63%) |
1/163 (0.61%) |
Supraventricular tachycardia |
1/165 (0.61%) |
0/158 (0.00%) |
1/163 (0.61%) |
Sinus tachycardia |
0/165 (0.00%) |
0/158 (0.00%) |
1/163 (0.61%) |
Cardiac failure congestive |
7/165 (4.24%) |
8/158 (5.06%) |
1/163 (0.61%) |
Angina pectoris |
1/165 (0.61%) |
1/158 (0.63%) |
1/163 (0.61%) |
Acute coronary syndrome |
1/165 (0.61%) |
0/158 (0.00%) |
0/163 (0.00%) |
Acute myocardial infarction |
1/165 (0.61%) |
0/158 (0.00%) |
0/163 (0.00%) |
Bradycardia |
1/165 (0.61%) |
2/158 (1.27%) |
0/163 (0.00%) |
Arrhythmia |
0/165 (0.00%) |
0/158 (0.00%) |
1/163 (0.61%) |
Tachycardia |
0/165 (0.00%) |
0/158 (0.00%) |
1/163 (0.61%) |
Cardiac arrest |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Cardio-respiratory arrest |
1/165 (0.61%) |
0/158 (0.00%) |
0/163 (0.00%) |
Ventricular fibrillation |
1/165 (0.61%) |
0/158 (0.00%) |
0/163 (0.00%) |
Pericardial effusion |
0/165 (0.00%) |
0/158 (0.00%) |
1/163 (0.61%) |
Right ventricular failure |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Tricuspid valve incompetence |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Orthostatic hypotension |
5/165 (3.03%) |
1/158 (0.63%) |
5/163 (3.07%) |
Gastrointestinal disorders |
|
|
|
Diarrhoea |
12/165 (7.27%) |
5/158 (3.16%) |
8/163 (4.91%) |
Vomiting |
3/165 (1.82%) |
5/158 (3.16%) |
6/163 (3.68%) |
Nausea |
2/165 (1.21%) |
4/158 (2.53%) |
4/163 (2.45%) |
Constipation |
6/165 (3.64%) |
3/158 (1.90%) |
3/163 (1.84%) |
Abdominal pain |
4/165 (2.42%) |
3/158 (1.90%) |
4/163 (2.45%) |
Gastrointestinal haemorrhage |
2/165 (1.21%) |
4/158 (2.53%) |
1/163 (0.61%) |
Ileus |
1/165 (0.61%) |
1/158 (0.63%) |
3/163 (1.84%) |
Intestinal obstruction |
1/165 (0.61%) |
0/158 (0.00%) |
0/163 (0.00%) |
Pancreatitis acute |
1/165 (0.61%) |
0/158 (0.00%) |
1/163 (0.61%) |
Pancreatitis |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Small intestinal obstruction |
1/165 (0.61%) |
1/158 (0.63%) |
1/163 (0.61%) |
Intestinal perforation |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Large intestinal ulcer |
1/165 (0.61%) |
0/158 (0.00%) |
0/163 (0.00%) |
Large intestine perforation |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Colitis |
1/165 (0.61%) |
0/158 (0.00%) |
0/163 (0.00%) |
Colitis ischaemic |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Rectal haemorrhage |
1/165 (0.61%) |
1/158 (0.63%) |
0/163 (0.00%) |
Abdominal hernia |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Faecaloma |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Gastric perforation |
1/165 (0.61%) |
0/158 (0.00%) |
0/163 (0.00%) |
Gastritis |
1/165 (0.61%) |
0/158 (0.00%) |
0/163 (0.00%) |
Enterocolitis |
0/165 (0.00%) |
0/158 (0.00%) |
1/163 (0.61%) |
Abdominal discomfort |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Diverticular perforation |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Intestinal ischaemia |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Ileus paralytic |
0/165 (0.00%) |
0/158 (0.00%) |
1/163 (0.61%) |
Stomatitis |
1/165 (0.61%) |
0/158 (0.00%) |
0/163 (0.00%) |
General disorders |
|
|
|
Asthenia |
6/165 (3.64%) |
3/158 (1.90%) |
3/163 (1.84%) |
Fatigue |
1/165 (0.61%) |
4/158 (2.53%) |
2/163 (1.23%) |
Pyrexia |
7/165 (4.24%) |
2/158 (1.27%) |
2/163 (1.23%) |
Pain |
0/165 (0.00%) |
1/158 (0.63%) |
2/163 (1.23%) |
Chest pain |
1/165 (0.61%) |
0/158 (0.00%) |
1/163 (0.61%) |
Non-cardiac chest pain |
0/165 (0.00%) |
2/158 (1.27%) |
0/163 (0.00%) |
Oedema peripheral |
1/165 (0.61%) |
2/158 (1.27%) |
1/163 (0.61%) |
Generalised oedema |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Death |
2/165 (1.21%) |
1/158 (0.63%) |
1/163 (0.61%) |
Multi-organ failure |
1/165 (0.61%) |
0/158 (0.00%) |
1/163 (0.61%) |
Chills |
0/165 (0.00%) |
0/158 (0.00%) |
1/163 (0.61%) |
Nodule |
1/165 (0.61%) |
0/158 (0.00%) |
0/163 (0.00%) |
Hepatobiliary disorders |
|
|
|
Cholecystitis |
1/165 (0.61%) |
1/158 (0.63%) |
0/163 (0.00%) |
Cholecystitis acute |
0/165 (0.00%) |
0/158 (0.00%) |
1/163 (0.61%) |
Hepatitis |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Hepatitis acute |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Hyperbilirubinaemia |
1/165 (0.61%) |
0/158 (0.00%) |
0/163 (0.00%) |
Immune system disorders |
|
|
|
Anaphylactic reaction |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Infections and infestations |
|
|
|
Pneumonia |
18/165 (10.91%) |
12/158 (7.59%) |
10/163 (6.13%) |
Lobar pneumonia |
1/165 (0.61%) |
2/158 (1.27%) |
1/163 (0.61%) |
Bronchitis |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Sepsis |
3/165 (1.82%) |
1/158 (0.63%) |
2/163 (1.23%) |
Bacteraemia |
1/165 (0.61%) |
1/158 (0.63%) |
2/163 (1.23%) |
Septic shock |
0/165 (0.00%) |
2/158 (1.27%) |
0/163 (0.00%) |
Bacterial sepsis |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Device related sepsis |
1/165 (0.61%) |
0/158 (0.00%) |
0/163 (0.00%) |
Urosepsis |
1/165 (0.61%) |
0/158 (0.00%) |
0/163 (0.00%) |
Urinary tract infection |
2/165 (1.21%) |
2/158 (1.27%) |
4/163 (2.45%) |
Pyelonephritis acute |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Gastroenteritis |
1/165 (0.61%) |
1/158 (0.63%) |
2/163 (1.23%) |
Diverticulitis |
0/165 (0.00%) |
1/158 (0.63%) |
1/163 (0.61%) |
Appendicitis |
0/165 (0.00%) |
0/158 (0.00%) |
1/163 (0.61%) |
Peritonitis |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Cellulitis |
3/165 (1.82%) |
1/158 (0.63%) |
0/163 (0.00%) |
Periorbital cellulitis |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Peritonitis bacterial |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Pneumonia bacterial |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Herpes zoster |
1/165 (0.61%) |
0/158 (0.00%) |
2/163 (1.23%) |
Herpes zoster disseminated |
0/165 (0.00%) |
0/158 (0.00%) |
1/163 (0.61%) |
Clostridium difficile colitis |
1/165 (0.61%) |
1/158 (0.63%) |
1/163 (0.61%) |
Staphylococcal abscess |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Staphylococcal bacteraemia |
1/165 (0.61%) |
0/158 (0.00%) |
0/163 (0.00%) |
Bursitis infective |
0/165 (0.00%) |
0/158 (0.00%) |
1/163 (0.61%) |
Oesophageal candidiasis |
1/165 (0.61%) |
0/158 (0.00%) |
0/163 (0.00%) |
Escherichia urinary tract infection |
0/165 (0.00%) |
0/158 (0.00%) |
1/163 (0.61%) |
Fungal skin infection |
0/165 (0.00%) |
0/158 (0.00%) |
1/163 (0.61%) |
Device related infection |
1/165 (0.61%) |
0/158 (0.00%) |
0/163 (0.00%) |
Pneumonia pneumococcal |
1/165 (0.61%) |
0/158 (0.00%) |
0/163 (0.00%) |
Viral infection |
0/165 (0.00%) |
0/158 (0.00%) |
1/163 (0.61%) |
Duodenal perforation |
0/165 (0.00%) |
0/158 (0.00%) |
1/163 (0.61%) |
Injury, poisoning and procedural complications |
|
|
|
Spinal compression fracture |
3/165 (1.82%) |
5/158 (3.16%) |
1/163 (0.61%) |
Ankle fracture |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Hip fracture |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Lower limb fracture |
1/165 (0.61%) |
0/158 (0.00%) |
0/163 (0.00%) |
Brain contusion |
0/165 (0.00%) |
0/158 (0.00%) |
1/163 (0.61%) |
Extradural haematoma |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Fall |
1/165 (0.61%) |
1/158 (0.63%) |
0/163 (0.00%) |
Fractured ischium |
1/165 (0.61%) |
0/158 (0.00%) |
0/163 (0.00%) |
Pelvic fracture |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Pubis fracture |
1/165 (0.61%) |
0/158 (0.00%) |
0/163 (0.00%) |
Laceration |
1/165 (0.61%) |
1/158 (0.63%) |
0/163 (0.00%) |
Coronary artery restenosis |
0/165 (0.00%) |
0/158 (0.00%) |
1/163 (0.61%) |
Drug dispensing error |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Tendon rupture |
0/165 (0.00%) |
0/158 (0.00%) |
1/163 (0.61%) |
Rib fracture |
1/165 (0.61%) |
0/158 (0.00%) |
0/163 (0.00%) |
Humerus fracture |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Investigations |
|
|
|
International normalised ratio increased |
1/165 (0.61%) |
1/158 (0.63%) |
1/163 (0.61%) |
Prothrombin time prolonged |
1/165 (0.61%) |
0/158 (0.00%) |
0/163 (0.00%) |
Alanine aminotransferase increased |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Aspartate aminotransferase increased |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Hepatic enzyme increased |
0/165 (0.00%) |
0/158 (0.00%) |
1/163 (0.61%) |
Blood creatinine increased |
1/165 (0.61%) |
0/158 (0.00%) |
1/163 (0.61%) |
Klebsiella test positive |
0/165 (0.00%) |
0/158 (0.00%) |
1/163 (0.61%) |
Blood culture positive |
0/165 (0.00%) |
0/158 (0.00%) |
1/163 (0.61%) |
Blood potassium decreased |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Haemoglobin decreased |
1/165 (0.61%) |
0/158 (0.00%) |
0/163 (0.00%) |
Troponin I increased |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
White blood cell count decreased |
0/165 (0.00%) |
0/158 (0.00%) |
1/163 (0.61%) |
Metabolism and nutrition disorders |
|
|
|
Dehydration |
8/165 (4.85%) |
6/158 (3.80%) |
9/163 (5.52%) |
Hypovolaemia |
2/165 (1.21%) |
1/158 (0.63%) |
0/163 (0.00%) |
Hyponatraemia |
3/165 (1.82%) |
1/158 (0.63%) |
4/163 (2.45%) |
Hypokalaemia |
2/165 (1.21%) |
3/158 (1.90%) |
1/163 (0.61%) |
Hyperkalaemia |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Hyperglycaemia |
2/165 (1.21%) |
2/158 (1.27%) |
0/163 (0.00%) |
Hypoglycaemia |
2/165 (1.21%) |
1/158 (0.63%) |
1/163 (0.61%) |
Hypercalcaemia |
0/165 (0.00%) |
1/158 (0.63%) |
1/163 (0.61%) |
Hypocalcaemia |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Decreased appetite |
1/165 (0.61%) |
1/158 (0.63%) |
0/163 (0.00%) |
Cachexia |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Failure to thrive |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Diabetes mellitus inadequate control |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Electrolyte imbalance |
0/165 (0.00%) |
0/158 (0.00%) |
1/163 (0.61%) |
Lactic acidosis |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Fluid overload |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Musculoskeletal and connective tissue disorders |
|
|
|
Back pain |
3/165 (1.82%) |
3/158 (1.90%) |
5/163 (3.07%) |
Pain in extremity |
2/165 (1.21%) |
2/158 (1.27%) |
2/163 (1.23%) |
Musculoskeletal chest pain |
0/165 (0.00%) |
0/158 (0.00%) |
2/163 (1.23%) |
Musculoskeletal pain |
1/165 (0.61%) |
0/158 (0.00%) |
1/163 (0.61%) |
Neck pain |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Muscular weakness |
2/165 (1.21%) |
3/158 (1.90%) |
3/163 (1.84%) |
Arthralgia |
1/165 (0.61%) |
1/158 (0.63%) |
0/163 (0.00%) |
Cervical spinal stenosis |
0/165 (0.00%) |
0/158 (0.00%) |
1/163 (0.61%) |
Lumbar spinal stenosis |
1/165 (0.61%) |
0/158 (0.00%) |
0/163 (0.00%) |
Bone pain |
0/165 (0.00%) |
0/158 (0.00%) |
1/163 (0.61%) |
Costochondritis |
1/165 (0.61%) |
0/158 (0.00%) |
0/163 (0.00%) |
Intervertebral disc compression |
1/165 (0.61%) |
0/158 (0.00%) |
0/163 (0.00%) |
Osteolysis |
1/165 (0.61%) |
0/158 (0.00%) |
0/163 (0.00%) |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
|
|
Multiple myeloma |
1/165 (0.61%) |
2/158 (1.27%) |
1/163 (0.61%) |
Plasmacytoma |
1/165 (0.61%) |
1/158 (0.63%) |
0/163 (0.00%) |
Cancer pain |
0/165 (0.00%) |
2/158 (1.27%) |
1/163 (0.61%) |
Metastases to liver |
0/165 (0.00%) |
0/158 (0.00%) |
1/163 (0.61%) |
Metastases to lung |
0/165 (0.00%) |
0/158 (0.00%) |
1/163 (0.61%) |
Nervous system disorders |
|
|
|
Neuropathy peripheral |
2/165 (1.21%) |
5/158 (3.16%) |
4/163 (2.45%) |
Peripheral sensory neuropathy |
3/165 (1.82%) |
3/158 (1.90%) |
0/163 (0.00%) |
Peripheral motor neuropathy |
2/165 (1.21%) |
1/158 (0.63%) |
0/163 (0.00%) |
Neuralgic amyotrophy |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Syncope |
5/165 (3.03%) |
5/158 (3.16%) |
5/163 (3.07%) |
Lethargy |
0/165 (0.00%) |
0/158 (0.00%) |
1/163 (0.61%) |
Cerebrovascular accident |
0/165 (0.00%) |
1/158 (0.63%) |
1/163 (0.61%) |
Haemorrhage intracranial |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Spinal haematoma |
1/165 (0.61%) |
0/158 (0.00%) |
0/163 (0.00%) |
Encephalopathy |
1/165 (0.61%) |
2/158 (1.27%) |
0/163 (0.00%) |
Dizziness |
0/165 (0.00%) |
1/158 (0.63%) |
1/163 (0.61%) |
Dizziness postural |
1/165 (0.61%) |
0/158 (0.00%) |
0/163 (0.00%) |
Dementia |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Dementia with Lewy bodies |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Hepatic encephalopathy |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Metabolic encephalopathy |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Hypoaesthesia |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Neuralgia |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
VIth nerve paralysis |
0/165 (0.00%) |
0/158 (0.00%) |
1/163 (0.61%) |
Sciatica |
1/165 (0.61%) |
0/158 (0.00%) |
0/163 (0.00%) |
Cognitive disorder |
0/165 (0.00%) |
0/158 (0.00%) |
1/163 (0.61%) |
Quadriplegia |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Convulsion |
1/165 (0.61%) |
0/158 (0.00%) |
0/163 (0.00%) |
Spinal cord compression |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Psychiatric disorders |
|
|
|
Confusional state |
1/165 (0.61%) |
0/158 (0.00%) |
1/163 (0.61%) |
Depression |
1/165 (0.61%) |
1/158 (0.63%) |
0/163 (0.00%) |
Mental status changes |
0/165 (0.00%) |
2/158 (1.27%) |
0/163 (0.00%) |
Panic attack |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Acute psychosis |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Withdrawal syndrome |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Renal and urinary disorders |
|
|
|
Renal failure |
2/165 (1.21%) |
1/158 (0.63%) |
3/163 (1.84%) |
Renal failure acute |
1/165 (0.61%) |
2/158 (1.27%) |
2/163 (1.23%) |
Renal impairment |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Urinary retention |
2/165 (1.21%) |
0/158 (0.00%) |
1/163 (0.61%) |
Nephrolithiasis |
0/165 (0.00%) |
0/158 (0.00%) |
1/163 (0.61%) |
Hydronephrosis |
0/165 (0.00%) |
0/158 (0.00%) |
1/163 (0.61%) |
Renal tubular necrosis |
0/165 (0.00%) |
0/158 (0.00%) |
1/163 (0.61%) |
Haematuria |
0/165 (0.00%) |
0/158 (0.00%) |
1/163 (0.61%) |
Respiratory, thoracic and mediastinal disorders |
|
|
|
Dyspnoea |
4/165 (2.42%) |
4/158 (2.53%) |
2/163 (1.23%) |
Pulmonary embolism |
5/165 (3.03%) |
4/158 (2.53%) |
1/163 (0.61%) |
Chronic obstructive pulmonary disease |
2/165 (1.21%) |
1/158 (0.63%) |
0/163 (0.00%) |
Asthma |
0/165 (0.00%) |
2/158 (1.27%) |
0/163 (0.00%) |
Respiratory failure |
1/165 (0.61%) |
2/158 (1.27%) |
0/163 (0.00%) |
Acute respiratory failure |
1/165 (0.61%) |
1/158 (0.63%) |
0/163 (0.00%) |
Pneumonitis |
2/165 (1.21%) |
0/158 (0.00%) |
1/163 (0.61%) |
Pneumonia aspiration |
0/165 (0.00%) |
0/158 (0.00%) |
1/163 (0.61%) |
Pulmonary hypertension |
0/165 (0.00%) |
3/158 (1.90%) |
0/163 (0.00%) |
Hypoxia |
2/165 (1.21%) |
0/158 (0.00%) |
0/163 (0.00%) |
Lung infiltration |
0/165 (0.00%) |
2/158 (1.27%) |
0/163 (0.00%) |
Pleural effusion |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Pneumothorax |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Pleuritic pain |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Skin and subcutaneous tissue disorders |
|
|
|
Hyperhidrosis |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Vascular disorders |
|
|
|
Hypotension |
3/165 (1.82%) |
3/158 (1.90%) |
6/163 (3.68%) |
Deep vein thrombosis |
7/165 (4.24%) |
4/158 (2.53%) |
2/163 (1.23%) |
Jugular vein thrombosis |
1/165 (0.61%) |
0/158 (0.00%) |
0/163 (0.00%) |
Peripheral embolism |
0/165 (0.00%) |
0/158 (0.00%) |
1/163 (0.61%) |
Shock haemorrhagic |
0/165 (0.00%) |
0/158 (0.00%) |
1/163 (0.61%) |
Phlebitis |
0/165 (0.00%) |
0/158 (0.00%) |
1/163 (0.61%) |
Indicates events were collected by systematic assessment
Term from vocabulary, MedDRA (15.0)
|
|
Frequency Threshold for Reporting Other Adverse Events
|
0%
|
|
Bortezomib and Dexamethasone
|
Bortezomib, Thalidomide, and Dexamethasone
|
Bortezomib, Melphalan and Prednisone
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
57/165 (34.55%) |
68/158 (43.04%) |
68/163 (41.72%) |
Blood and lymphatic system disorders |
|
|
|
Leukopenia |
2/165 (1.21%) |
1/158 (0.63%) |
12/163 (7.36%) |
Lymphopenia |
0/165 (0.00%) |
2/158 (1.27%) |
4/163 (2.45%) |
Leukocytosis |
0/165 (0.00%) |
1/158 (0.63%) |
1/163 (0.61%) |
Lymphadenopathy |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Cardiac disorders |
|
|
|
Pericarditis |
0/165 (0.00%) |
0/158 (0.00%) |
1/163 (0.61%) |
Restrictive cardiomyopathy |
0/165 (0.00%) |
0/158 (0.00%) |
1/163 (0.61%) |
Sick sinus syndrome |
0/165 (0.00%) |
0/158 (0.00%) |
1/163 (0.61%) |
Sinus bradycardia |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Ventricular extrasystoles |
1/165 (0.61%) |
0/158 (0.00%) |
0/163 (0.00%) |
Ventricular tachycardia |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Ear and labyrinth disorders |
|
|
|
Hypoacusis |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Endocrine disorders |
|
|
|
Adrenal insufficiency |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Cushingoid |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Inappropriate antidiuretic hormone secretion |
0/165 (0.00%) |
0/158 (0.00%) |
1/163 (0.61%) |
Eye disorders |
|
|
|
Vision blurred |
3/165 (1.82%) |
5/158 (3.16%) |
1/163 (0.61%) |
Conjunctivitis |
1/165 (0.61%) |
2/158 (1.27%) |
1/163 (0.61%) |
Eye swelling |
2/165 (1.21%) |
0/158 (0.00%) |
0/163 (0.00%) |
Visual impairment |
0/165 (0.00%) |
2/158 (1.27%) |
0/163 (0.00%) |
Blepharitis |
1/165 (0.61%) |
0/158 (0.00%) |
0/163 (0.00%) |
Conjunctivitis allergic |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Diplopia |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Eye haemorrhage |
0/165 (0.00%) |
0/158 (0.00%) |
1/163 (0.61%) |
Eye pruritus |
0/165 (0.00%) |
0/158 (0.00%) |
1/163 (0.61%) |
Lacrimation increased |
0/165 (0.00%) |
0/158 (0.00%) |
1/163 (0.61%) |
Ocular hyperaemia |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Gastrointestinal disorders |
|
|
|
Dyspepsia |
3/165 (1.82%) |
3/158 (1.90%) |
0/163 (0.00%) |
Abdominal pain upper |
1/165 (0.61%) |
2/158 (1.27%) |
1/163 (0.61%) |
Abdominal distension |
0/165 (0.00%) |
1/158 (0.63%) |
1/163 (0.61%) |
Dry mouth |
0/165 (0.00%) |
1/158 (0.63%) |
1/163 (0.61%) |
Gastrooesophageal reflux disease |
0/165 (0.00%) |
2/158 (1.27%) |
0/163 (0.00%) |
Ascites |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Flatulence |
0/165 (0.00%) |
0/158 (0.00%) |
1/163 (0.61%) |
Hiatus hernia |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Toothache |
1/165 (0.61%) |
0/158 (0.00%) |
0/163 (0.00%) |
General disorders |
|
|
|
Gait disturbance |
0/165 (0.00%) |
1/158 (0.63%) |
2/163 (1.23%) |
Catheter site erythema |
0/165 (0.00%) |
0/158 (0.00%) |
1/163 (0.61%) |
Drug withdrawal syndrome |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Face oedema |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Feeling jittery |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Influenza like illness |
1/165 (0.61%) |
0/158 (0.00%) |
0/163 (0.00%) |
Irritability |
1/165 (0.61%) |
0/158 (0.00%) |
0/163 (0.00%) |
Malaise |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Oedema |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Soft tissue inflammation |
1/165 (0.61%) |
0/158 (0.00%) |
0/163 (0.00%) |
Hepatobiliary disorders |
|
|
|
Cholelithiasis |
0/165 (0.00%) |
0/158 (0.00%) |
1/163 (0.61%) |
Immune system disorders |
|
|
|
Seasonal allergy |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Infections and infestations |
|
|
|
Oral candidiasis |
1/165 (0.61%) |
0/158 (0.00%) |
4/163 (2.45%) |
Upper respiratory tract infection |
2/165 (1.21%) |
1/158 (0.63%) |
2/163 (1.23%) |
Conjunctivitis bacterial |
0/165 (0.00%) |
2/158 (1.27%) |
0/163 (0.00%) |
Hordeolum |
0/165 (0.00%) |
2/158 (1.27%) |
0/163 (0.00%) |
Oral fungal infection |
0/165 (0.00%) |
1/158 (0.63%) |
1/163 (0.61%) |
Sinusitis |
1/165 (0.61%) |
1/158 (0.63%) |
0/163 (0.00%) |
Bronchopulmonary aspergillosis |
0/165 (0.00%) |
0/158 (0.00%) |
1/163 (0.61%) |
Cystitis |
0/165 (0.00%) |
0/158 (0.00%) |
1/163 (0.61%) |
Folliculitis |
0/165 (0.00%) |
0/158 (0.00%) |
1/163 (0.61%) |
Furuncle |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Gastroenteritis viral |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Herpes zoster ophthalmic |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Localised infection |
1/165 (0.61%) |
0/158 (0.00%) |
0/163 (0.00%) |
Nasopharyngitis |
1/165 (0.61%) |
0/158 (0.00%) |
0/163 (0.00%) |
Pneumococcal sepsis |
1/165 (0.61%) |
0/158 (0.00%) |
0/163 (0.00%) |
Skin bacterial infection |
0/165 (0.00%) |
0/158 (0.00%) |
1/163 (0.61%) |
Subcutaneous abscess |
1/165 (0.61%) |
0/158 (0.00%) |
0/163 (0.00%) |
Injury, poisoning and procedural complications |
|
|
|
Avulsion fracture |
0/165 (0.00%) |
0/158 (0.00%) |
1/163 (0.61%) |
Contusion |
1/165 (0.61%) |
0/158 (0.00%) |
0/163 (0.00%) |
Excoriation |
0/165 (0.00%) |
0/158 (0.00%) |
1/163 (0.61%) |
Facial bones fracture |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Foot fracture |
1/165 (0.61%) |
0/158 (0.00%) |
0/163 (0.00%) |
Jaw fracture |
0/165 (0.00%) |
0/158 (0.00%) |
1/163 (0.61%) |
Lumbar vertebral fracture |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Thoracic vertebral fracture |
0/165 (0.00%) |
0/158 (0.00%) |
1/163 (0.61%) |
Investigations |
|
|
|
Weight decreased |
4/165 (2.42%) |
2/158 (1.27%) |
6/163 (3.68%) |
Platelet count decreased |
3/165 (1.82%) |
1/158 (0.63%) |
7/163 (4.29%) |
Blood sodium decreased |
3/165 (1.82%) |
3/158 (1.90%) |
3/163 (1.84%) |
Blood uric acid increased |
2/165 (1.21%) |
3/158 (1.90%) |
3/163 (1.84%) |
Neutrophil count decreased |
0/165 (0.00%) |
0/158 (0.00%) |
6/163 (3.68%) |
Blood alkaline phosphatase increased |
0/165 (0.00%) |
0/158 (0.00%) |
3/163 (1.84%) |
Blood urea increased |
1/165 (0.61%) |
1/158 (0.63%) |
1/163 (0.61%) |
Protein total increased |
1/165 (0.61%) |
1/158 (0.63%) |
1/163 (0.61%) |
Weight increased |
0/165 (0.00%) |
3/158 (1.90%) |
0/163 (0.00%) |
Blood bilirubin increased |
0/165 (0.00%) |
1/158 (0.63%) |
1/163 (0.61%) |
Troponin T increased |
1/165 (0.61%) |
0/158 (0.00%) |
1/163 (0.61%) |
Blood calcium increased |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Blood chloride decreased |
0/165 (0.00%) |
0/158 (0.00%) |
1/163 (0.61%) |
Blood creatinine decreased |
0/165 (0.00%) |
0/158 (0.00%) |
1/163 (0.61%) |
Blood glucose increased |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Blood immunoglobulin G increased |
1/165 (0.61%) |
0/158 (0.00%) |
0/163 (0.00%) |
Blood phosphorus decreased |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Blood potassium increased |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Breath sounds abnormal |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Carbon monoxide diffusing capacity decreased |
1/165 (0.61%) |
0/158 (0.00%) |
0/163 (0.00%) |
Lymphocyte count decreased |
0/165 (0.00%) |
0/158 (0.00%) |
1/163 (0.61%) |
Lymphocyte count increased |
1/165 (0.61%) |
0/158 (0.00%) |
0/163 (0.00%) |
Red blood cell count decreased |
1/165 (0.61%) |
0/158 (0.00%) |
0/163 (0.00%) |
Metabolism and nutrition disorders |
|
|
|
Hyperuricaemia |
3/165 (1.82%) |
8/158 (5.06%) |
4/163 (2.45%) |
Hypomagnesaemia |
0/165 (0.00%) |
1/158 (0.63%) |
2/163 (1.23%) |
Diabetes mellitus |
0/165 (0.00%) |
2/158 (1.27%) |
0/163 (0.00%) |
Hypophosphataemia |
1/165 (0.61%) |
1/158 (0.63%) |
0/163 (0.00%) |
Gout |
0/165 (0.00%) |
0/158 (0.00%) |
1/163 (0.61%) |
Hyperlipidaemia |
0/165 (0.00%) |
0/158 (0.00%) |
1/163 (0.61%) |
Hypoalbuminaemia |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Vitamin B12 deficiency |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Musculoskeletal and connective tissue disorders |
|
|
|
Muscle spasms |
1/165 (0.61%) |
2/158 (1.27%) |
1/163 (0.61%) |
Myalgia |
3/165 (1.82%) |
0/158 (0.00%) |
0/163 (0.00%) |
Groin pain |
0/165 (0.00%) |
2/158 (1.27%) |
0/163 (0.00%) |
Flank pain |
0/165 (0.00%) |
0/158 (0.00%) |
1/163 (0.61%) |
Joint swelling |
1/165 (0.61%) |
0/158 (0.00%) |
0/163 (0.00%) |
Muscle tightness |
0/165 (0.00%) |
0/158 (0.00%) |
1/163 (0.61%) |
Musculoskeletal stiffness |
1/165 (0.61%) |
0/158 (0.00%) |
0/163 (0.00%) |
Neck mass |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Osteonecrosis |
0/165 (0.00%) |
0/158 (0.00%) |
1/163 (0.61%) |
Pain in jaw |
0/165 (0.00%) |
0/158 (0.00%) |
1/163 (0.61%) |
Pathological fracture |
0/165 (0.00%) |
0/158 (0.00%) |
1/163 (0.61%) |
Rotator cuff syndrome |
0/165 (0.00%) |
0/158 (0.00%) |
1/163 (0.61%) |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
|
|
Tumour pain |
0/165 (0.00%) |
0/158 (0.00%) |
1/163 (0.61%) |
Nervous system disorders |
|
|
|
Dysgeusia |
2/165 (1.21%) |
4/158 (2.53%) |
2/163 (1.23%) |
Post herpetic neuralgia |
2/165 (1.21%) |
2/158 (1.27%) |
1/163 (0.61%) |
Tremor |
2/165 (1.21%) |
2/158 (1.27%) |
1/163 (0.61%) |
Balance disorder |
2/165 (1.21%) |
2/158 (1.27%) |
0/163 (0.00%) |
Paraesthesia |
1/165 (0.61%) |
0/158 (0.00%) |
3/163 (1.84%) |
Headache |
1/165 (0.61%) |
1/158 (0.63%) |
1/163 (0.61%) |
Peripheral sensorimotor neuropathy |
0/165 (0.00%) |
1/158 (0.63%) |
2/163 (1.23%) |
Somnolence |
1/165 (0.61%) |
2/158 (1.27%) |
0/163 (0.00%) |
Ageusia |
1/165 (0.61%) |
0/158 (0.00%) |
1/163 (0.61%) |
Cranial nerve disorder |
0/165 (0.00%) |
2/158 (1.27%) |
0/163 (0.00%) |
Dysarthria |
0/165 (0.00%) |
2/158 (1.27%) |
0/163 (0.00%) |
Memory impairment |
1/165 (0.61%) |
1/158 (0.63%) |
0/163 (0.00%) |
Ataxia |
0/165 (0.00%) |
0/158 (0.00%) |
1/163 (0.61%) |
Hemiparesis |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Hypogeusia |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Polyneuropathy |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Presyncope |
1/165 (0.61%) |
0/158 (0.00%) |
0/163 (0.00%) |
Psychiatric disorders |
|
|
|
Insomnia |
9/165 (5.45%) |
6/158 (3.80%) |
6/163 (3.68%) |
Anxiety |
1/165 (0.61%) |
1/158 (0.63%) |
1/163 (0.61%) |
Mood altered |
2/165 (1.21%) |
1/158 (0.63%) |
0/163 (0.00%) |
Disorientation |
1/165 (0.61%) |
1/158 (0.63%) |
0/163 (0.00%) |
Mood swings |
2/165 (1.21%) |
0/158 (0.00%) |
0/163 (0.00%) |
Agitation |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Anhedonia |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Anxiety disorder due to a general medical condition |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Delusion |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Depressed mood |
1/165 (0.61%) |
0/158 (0.00%) |
0/163 (0.00%) |
Dysphoria |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Psychotic disorder |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Restlessness |
1/165 (0.61%) |
0/158 (0.00%) |
0/163 (0.00%) |
Renal and urinary disorders |
|
|
|
Dysuria |
2/165 (1.21%) |
0/158 (0.00%) |
3/163 (1.84%) |
Pollakiuria |
0/165 (0.00%) |
1/158 (0.63%) |
2/163 (1.23%) |
Urinary incontinence |
1/165 (0.61%) |
0/158 (0.00%) |
1/163 (0.61%) |
Azotaemia |
0/165 (0.00%) |
0/158 (0.00%) |
1/163 (0.61%) |
Nocturia |
1/165 (0.61%) |
0/158 (0.00%) |
0/163 (0.00%) |
Reproductive system and breast disorders |
|
|
|
Pelvic pain |
2/165 (1.21%) |
0/158 (0.00%) |
0/163 (0.00%) |
Erectile dysfunction |
1/165 (0.61%) |
0/158 (0.00%) |
0/163 (0.00%) |
Vaginal haemorrhage |
1/165 (0.61%) |
0/158 (0.00%) |
0/163 (0.00%) |
Respiratory, thoracic and mediastinal disorders |
|
|
|
Cough |
3/165 (1.82%) |
5/158 (3.16%) |
3/163 (1.84%) |
Oropharyngeal pain |
2/165 (1.21%) |
2/158 (1.27%) |
1/163 (0.61%) |
Dysphonia |
0/165 (0.00%) |
2/158 (1.27%) |
0/163 (0.00%) |
Epistaxis |
0/165 (0.00%) |
1/158 (0.63%) |
1/163 (0.61%) |
Nasal congestion |
1/165 (0.61%) |
1/158 (0.63%) |
0/163 (0.00%) |
Productive cough |
0/165 (0.00%) |
2/158 (1.27%) |
0/163 (0.00%) |
Sinus congestion |
1/165 (0.61%) |
1/158 (0.63%) |
0/163 (0.00%) |
Atelectasis |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Dyspnoea exertional |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Rales |
0/165 (0.00%) |
0/158 (0.00%) |
1/163 (0.61%) |
Respiratory tract congestion |
1/165 (0.61%) |
0/158 (0.00%) |
0/163 (0.00%) |
Sleep apnoea syndrome |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Wheezing |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Skin and subcutaneous tissue disorders |
|
|
|
Rash pruritic |
0/165 (0.00%) |
5/158 (3.16%) |
3/163 (1.84%) |
Pruritus |
1/165 (0.61%) |
1/158 (0.63%) |
4/163 (2.45%) |
Decubitus ulcer |
1/165 (0.61%) |
1/158 (0.63%) |
1/163 (0.61%) |
Rash erythematous |
0/165 (0.00%) |
1/158 (0.63%) |
2/163 (1.23%) |
Dermatitis |
0/165 (0.00%) |
0/158 (0.00%) |
2/163 (1.23%) |
Drug eruption |
0/165 (0.00%) |
2/158 (1.27%) |
0/163 (0.00%) |
Dry skin |
0/165 (0.00%) |
2/158 (1.27%) |
0/163 (0.00%) |
Rash macular |
0/165 (0.00%) |
1/158 (0.63%) |
1/163 (0.61%) |
Acne |
0/165 (0.00%) |
0/158 (0.00%) |
1/163 (0.61%) |
Alopecia |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Dermatitis allergic |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Dermatitis bullous |
0/165 (0.00%) |
0/158 (0.00%) |
1/163 (0.61%) |
Dermatitis exfoliative |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Diabetic foot |
0/165 (0.00%) |
0/158 (0.00%) |
1/163 (0.61%) |
Ecchymosis |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Erythema |
0/165 (0.00%) |
0/158 (0.00%) |
1/163 (0.61%) |
Exfoliative rash |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Heat rash |
1/165 (0.61%) |
0/158 (0.00%) |
0/163 (0.00%) |
Lichenoid keratosis |
0/165 (0.00%) |
0/158 (0.00%) |
1/163 (0.61%) |
Palmar-plantar erythrodysaesthesia syndrome |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Petechiae |
0/165 (0.00%) |
0/158 (0.00%) |
1/163 (0.61%) |
Rash |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Rash maculo-papular |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Rash vesicular |
0/165 (0.00%) |
0/158 (0.00%) |
1/163 (0.61%) |
Skin lesion |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Skin ulcer |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Swelling face |
1/165 (0.61%) |
0/158 (0.00%) |
0/163 (0.00%) |
Urticaria |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Vascular disorders |
|
|
|
Hypertension |
0/165 (0.00%) |
3/158 (1.90%) |
2/163 (1.23%) |
Hot flush |
1/165 (0.61%) |
0/158 (0.00%) |
1/163 (0.61%) |
Haematoma |
1/165 (0.61%) |
0/158 (0.00%) |
0/163 (0.00%) |
Thrombophlebitis superficial |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Thrombosis |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Withdrawal hypertension |
0/165 (0.00%) |
1/158 (0.63%) |
0/163 (0.00%) |
Indicates events were collected by systematic assessment
Term from vocabulary, MedDRA (15.0)
|