Table 3 The top 8 signal strength of AEs refered to four SOCs.
SOC | APR | FAP | RP | ||||||
|---|---|---|---|---|---|---|---|---|---|
General disorders and administration site conditions | PTs | n | Intensity | PTs | n | Intensity | PTs | n | Intensity |
Injection site vasculitis | 13 | +++ | Injection site vasculitis | 12 | +++ | Feeling hot | 47 | ++ | |
Injection site phlebitis | 29 | +++ | Injection site phlebitis | 26 | +++ | Chest discomfort | 30 | + | |
Infusion site phlebitis | 6 | +++ | Infusion site irritation | 8 | +++ | Death | 241 | + | |
Infusion site irritation | 18 | +++ | Infusion site reaction | 8 | +++ | Chest pain | 28 | + | |
Infusion site urticaria | 8 | +++ | Infusion site discomfort | 3 | +++ | Disease progression | 17 | + | |
Infusion site rash | 11 | +++ | Infusion site pain | 32 | +++ | Chills | 8 | — | |
Therapeutic producteffective for unapproved indication | 3 | +++ | Infusion site induration | 3 | +++ | Adverse drug reaction | 6 | — | |
Infusion site reaction | 17 | +++ | Injection site atrophy | 4 | +++ | Illness | 6 | — | |
Nervous system disorders | Tonic clonic movements | 4 | ++ | Seizure like phenomena | 3 | +++ | Unresponsive to stimuli | 3 | + |
Encephalopathy | 69 | ++ | Unresponsive to stimuli | 11 | + | Cerebral haemorrhage | 4 | + | |
Seizure like phenomena | 4 | ++ | Presyncope | 6 | + | Dizziness | 45 | — | |
Toxic encephalopathy | 8 | ++ | Sensory disturbance | 3 | + | Loss of consciousness | 10 | — | |
Clonus | 4 | + | Depressed level of consciousness | 6 | — | Hypoaesthesia | 9 | — | |
Muscle contractions involuntary | 4 | + | Loss of consciousness | 15 | — | Neuropathy peripheral | 6 | — | |
Peripheral sensory neuropathy | 6 | + | Paraesthesia | 17 | — | Seizure | 8 | — | |
Unresponsive to stimuli | 20 | + | Aphasia | 3 | — | Burning sensation | 3 | — | |
Endocrine disorders | Inappropriate antidiuretic hormone secretion | 15 | ++ | Inappropriate antidiuretic hormone secretion | 3 | + | Â | Â | Â |
Adrenal insufficiency | 5 | — | Adrenal insufficiency | 3 | + |  |  |  | |
Hypothyroidism | 3 | — |  |  |  |  |  |  | |
Musculoskeletal and connective tissue disorders | Joint deposit | 3 | +++ | Back pain | 52 | + | Back pain | 32 | + |
Facet joint syndrome | 4 | ++ | Muscle twitching | 4 | — | Bone pain | 3 | — | |
Rheumatic fever | 5 | ++ | Musculoskeletal pain | 6 | — | Muscle spasms | 5 | — | |
Hand deformity | 12 | + | Neck pain | 4 | — | Arthralgia | 4 | — | |
Back pain | 163 | + | Muscle spasms | 10 | — |  |  |  | |
Synovitis | 11 | + | Pain in extremity | 14 | — |  |  |  | |
Joint range of motion decreased | 6 | — | Myalgia | 7 | — |  |  |  | |
Flank pain | 4 | — | Arthralgia | 8 | — |  |  |  | |
