Table 5.
Adverse events of interest observed during talimogene laherparepvec treatment
| Events of interesta | Austria, Germany, UK (n = 35) | Netherlands (n = 31) | Total (N = 66) | |||
|---|---|---|---|---|---|---|
| n | % | n | % | n | % | |
| Administration-site conditions | 5 | 14.3 | 25 | 80.6 | 30 | 45.5 |
| Burning sensation | 0 | 0.0 | 4 | 12.9 | 4 | 6.1 |
| Erythema | 1 | 2.9 | 12 | 38.7 | 13 | 19.7 |
| Injection-site complications | 3 | 8.6 | 3 | 9.7 | 6 | 9.1 |
| Injection-site pain | 2 | 5.7b | 11 | 35.5 | 13 | 19.7 |
| Pruritus left leg | 1 | 2.9 | 0 | 0 | 1 | 1.5 |
| Rash/itch | 0 | 0 | 11 | 35.5 | 11 | 16.7 |
| Wateriness left shank | 1 | 2.9 | 0 | 0 | 1 | 1.5 |
| Gastrointestinal disorders | 4 | 11.4 | 8 | 25.8 | 12 | 18.2 |
| Abdominal pain | 0 | 0 | 1 | 3.2 | 1 | 1.5 |
| Decreased appetite | 0 | 0 | 4 | 12.9 | 4 | 6.1 |
| Diarrhoea | 0 | 0 | 1 | 3.2 | 1 | 1.5 |
| Nausea | 4 | 11.4 | 3 | 9.7 | 7 | 10.6 |
| Vomiting | 1 | 2.9 | 0 | 0 | 1 | 1.5 |
| General disorders | 5 | 14.3 | 27 | 87.1 | 32 | 48.5 |
| Ague (fever and chills) | 2 | 5.7 | 0 | 0 | 2 | 3.0 |
| Dizziness | 0 | 0 | 1 | 3.2 | 1 | 1.5 |
| Dyspnoea | 0 | 0 | 1 | 3.2 | 1 | 1.5 |
| Fatigue | 0 | 0 | 14 | 45.2 | 14 | 21.2 |
| Fever | 3 | 8.6 | 5 | 16.1 | 8 | 12.1 |
| Flu-like symptoms | 0 | 0 | 24 | 77.4 | 24 | 36.4 |
| Hot flush/sweating | 1 | 2.9 | 1 | 3.2 | 2 | 3.0 |
| Herpetic events | 0 | 0 | 1c | 3.2 | 1c | 1.5 |
| Physician-defined immune-mediated events | 3 | 8.6d | 1 | 3.2 | 4 | 6.1 |
| Other | 2 | 5.7 | 9 | 29.0 | 11 | 16.7 |
| Airway infection | 0 | 0 | 1 | 3.2 | 1 | 1.5 |
| Arthralgia | 0 | 0 | 1 | 3.2 | 1 | 1.5 |
| Oedema right ankle | 0 | 0 | 1 | 3.2 | 1 | 1.5 |
| Headache | 1 | 2.9 | 5 | 16.1 | 6 | 9.1 |
| Increase in liver enzymes | 1 | 2.9 | 0 | 0 | 1 | 1.5 |
| Muscle ache | 0 | 0 | 2 | 6.5 | 2 | 3.0 |
| Myocardial infarction | 0 | 0 | 1 | 3.2 | 1 | 1.5 |
| Pain in joints | 0 | 0 | 1 | 3.2 | 1 | 1.5 |
| Urine incontinence | 0 | 0 | 1 | 3.2 | 1 | 1.5 |
aSubjects with multiple adverse events are only reported once per event term
bPain left foot, pain left shank
cThe details of this event are as follows: The time from the first talimogene laherparepvec (T-VEC) dose to the herpetic event was 176 days. The event occurred 4–5 days after an administration of T-VEC. The patient suffered from local redness, vesicles on trunk, and flu-like illness. There was no itching or fever. A physical examination (1.5 weeks after the event) showed no more vesicles, therefore no diagnostics (polymerase chain reaction) could be carried out. This event was recorded by the Amgen safety department as an unconfirmed herpetic event because the symptoms were suggestive, but not confirmed
dPhysician-defined immune-mediated events were eczema, increased 2-deoxy-2-fluoro-d-glucose (FDG) uptake in distant nodes without progression, and vitiligo. Only one event (vitiligo) appeared to be associated with T-VEC