Table 4.
Adverse reactions occurring in ≥10% of patients <60 and ≥60 years of age in the 3101 and 3102 studies.
| 3101 and 3102 Studies (NHL and MM) | ||||||||
|---|---|---|---|---|---|---|---|---|
|
| ||||||||
| <60 years | ≥60 years | |||||||
|
| ||||||||
|
Plerixafor + G-CSF
(n = 172) |
Placebo + G-CSF
(n = 159) |
Plerixafor + G-CSF
(n = 126) |
Placebo + G-CSF
(n = 143) |
|||||
|
| ||||||||
| All Grades (%) |
Grades ≥3 (%) |
All Grades (%) |
Grades ≥3 (%) |
All Grades (%) |
Grades ≥3 (%) |
All Grades (%) |
Grades ≥3 (%) |
|
|
| ||||||||
|
Blood and lymphatic system
disorders |
14.0 | 8.7 | 15.1 | 5.7 | 16.7 | 9.5 | 11.9 | 8.4 |
|
| ||||||||
| Febrile neutropenia | 9.3 | 7.0 | 6.3 | 4.4 | 11.1 | 7.1 | 5.6 | 4.9 |
|
| ||||||||
| Cardiac disorders | 7.6 | 1.2 | 7.5 | 1.3 | 9.5 | 1.6 | 13.3 | 3.5 |
|
| ||||||||
| Gastrointestinal disorders | 69.2 | 8.7 | 49.1 | 1.9 | 73.8 | 7.1 | 58.0 | 9.1 |
|
| ||||||||
| Diarrhea | 38.4 | 3.5 | 15.7 | 0.0 | 41.3 | 2.4 | 23.1 | 2.1 |
|
| ||||||||
| Nausea | 37.8 | 2.9 | 27.7 | 0.6 | 38.9 | 4.0 | 24.5 | 3.5 |
|
| ||||||||
| Vomiting | 15.1 | 2.3 | 7.5 | 0.6 | 12.7 | 3.2 | 10.5 | 1.4 |
|
| ||||||||
|
General disorders and
Administration site conditions |
77.3 | 14.5 | 67.9 | 7.5 | 74.6 | 10.3 | 60.8 | 7.0 |
|
| ||||||||
| Catheter site pain | 11.6 | - | 17.6 | - | 11.1 | - | 8.4 | - |
| Fatigue | 29.1 | 1.2 | 27.0 | 0.0 | 30.2 | 0.0 | 24.5 | 0.0 |
| Injection site erythema | 25.0 | - | 4.4 | - | 29.4 | - | 5.6 | - |
| Mucosal inflammation | 15.7 | 10.5 | 10.7 | 6.3 | 15.1 | 8.7 | 8.4 | 5.6 |
| Oedema peripheral | 7.6 | - | 6.9 | - | 11.9 | - | 11.9 | - |
| Pain | 9.9 | 0.6 | 11.3 | 0.0 | 4.8 | 0.0 | 5.6 | 0.0 |
| Pyrexia | 13.4 | 2.3 | 13.8 | 0.6 | 6.3 | 0.8 | 7.7 | 1.4 |
|
| ||||||||
| Infections and infestations | 28.5 | 14.0 | 22.0 | 11.9 | 22.2 | 13.5 | 18.9 | 9.8 |
|
| ||||||||
|
Injury, poisoning, and procedural
complications * |
12.2 | 1.2 | 10.7 | 1.9 | 9.5 | 3.2 | 6.3 | 0.7 |
|
| ||||||||
| Investigations † | 12.2 | 1.2 | 14.5 | 1.9 | 11.9 | 0.0 | 15.4 | 1.4 |
|
| ||||||||
| Metabolism and nutrition disorders | 29.1 | 2.3 | 28.9 | 3.1 | 33.3 | 4.8 | 30.1 | 3.5 |
|
| ||||||||
| Hypokalemia | 16.3 | 0.6 | 15.7 | 1.3 | 16.7 | 1.6 | 18.2 | 1.4 |
|
| ||||||||
| Hypomagnesemia | 9.9 | 0.0 | 10.7 | 0.6 | 9.5 | 0.0 | 8.4 | 0.7 |
|
| ||||||||
|
Musculoskeletal and connective
tissue disorders |
66.9 | 2.9 | 62.9 | 3.1 | 55.6 | 0.0 | 63.6 | 1.4 |
|
| ||||||||
| Arthralgia | 15.7 | - | 12.6 | - | 9.5 | - | 11.9 | - |
| Back pain | 19.8 | 0.6 | 20.8 | 1.3 | 17.5 | 0.0 | 23.1 | 0.0 |
| Bone pain | 36.0 | 1.7 | 39.0 | 0.6 | 27.8 | 0.0 | 30.1 | 0.0 |
|
| ||||||||
| Nervous system disorders | 50.6 | 2.9 | 51.6 | 1.3 | 45.2 | 3.2 | 35.7 | 0.7 |
|
| ||||||||
| Dizziness | 9.3 | 0.0 | 7.5 | 0.0 | 11.9 | 0.8 | 4.9 | 0.0 |
| Headache | 26.2 | 0.6 | 25.8 | 1.3 | 17.5 | 0.0 | 16.1 | 0.7 |
| Paraesthesia | 20.3 | - | 23.9 | - | 20.6 | - | 18.2 | - |
|
| ||||||||
| Psychiatric disorders | 20.9 | 1.7 | 10.1 | 0.0 | 13.5 | 1.6 | 11.9 | 0.7 |
|
| ||||||||
|
Respiratory, thoracic and
mediastinal disorders |
18.6 | 1.2 | 23.3 | 3.1 | 21.4 | 6.3 | 14.7 | 1.4 |
|
| ||||||||
|
Skin and subcutaneous tissue
disorders |
23.8 | 0.6 | 15.1 | 0.6 | 23.8 | 0.0 | 16.8 | 0.7 |
|
| ||||||||
| Vascular disorders | 12.2 | 1.7 | 13.2 | 1.3 | 17.5 | 4.0 | 10.5 | 2.1 |
*
Injury, poisoning, and procedural complications included: ankle fracture, delayed engraftment, drug toxicity, hip fracture, incorrect route of drug administration, lung injury, procedural hypertension, procedural pain, subdural hematoma, and transfusion-related acute lung injury.
†
Investigations included: alanine aminotransferase, aspartate aminotransferase, blood potassium, blood uric acid, gamma-glutamyltransferase, hepatic enzymes, liver function test, and platelet count.