Table 3.
Summary of Adverse Events Through Week 256
| Preferred Term | ITT, Maintenance-Exposed, Randomized Population | Extension-Switch Population | ||
|---|---|---|---|---|
| Q8W IM | Q4W IM | Q8W IM | Q4W IM | |
| (n = 115) | (n = 115) | (n = 34) | (n = 10) | |
| Any AE | 115 (100) | 115 (100) | 34 (100) | 10 (100) |
| AE, excluding ISRa | ||||
| Nasopharyngitis | 50 (43) | 53 (46) | 6 (18) | 5 (50) |
| Diarrhea | 35 (30) | 30 (26) | 3 (9) | 2 (20) |
| Headache | 29 (25) | 26 (23) | 3 (9) | 0 |
| Influenza | 20 (17) | 26 (23) | 7 (21) | 3 (30) |
| Back pain | 20 (17) | 26 (23) | 5 (15) | 3 (30) |
| Syphilis | 32 (28) | 22 (19) | 2 (6) | 2 (20) |
| Upper respiratory tract infection | 28 (24) | 26 (23) | 5 (15) | 1 (10) |
| Gastroenteritis | 26 (23) | 22 (19) | 7 (21) | 0 |
| Grade ≥3 AE | 39 (34) | 38 (33) | 7 (21) | 3 (30) |
| Excluding ISR | 31 (27) | 35 (30) | 4 (12) | 2 (20) |
| Drug related, excluding ISR | 4 (3) | 7 (6) | 0 | 0 |
| SAE | 25 (22) | 27 (23) | 6 (18) | 1 (10) |
| Excluding ISR | 25 (22) | 27 (23) | 6 (18) | 1 (10) |
| Drug related | 1 (<1)b | 2 (2)c | 0 | 0 |
| Fatal SAE | 0 | 3 (3)d | 0 | 0 |
| AE leading to withdrawale | 3 (3) | 20 (17) | 1 (3) | 1 (10) |
| Excluding ISR | 2 (2)f | 18 (16)g | 1 (3)h | 0 |
| Drug related | 2 (2) | 8 (7) | 1 (3) | 1 (10)i |
Data are presented as No. (%).
Abbreviations: AE, adverse event; IM, intramuscular; ISR, injection site reaction; ITT, intention to treat; Q4W, every 4 weeks; Q8W, every 8 weeks; SAE, serious adverse event.
aAEs reported in >20% of participants in a treatment group.
bDelusion and depression.
cChest pain and abdominal pain, dyspnea, flushing, and myocardial infarction (n = 1 participant each).
dEpilepsy (unrelated to study treatment), toxicity to various agents (unrelated to study treatment), and myocardial infarction (drug related) in 1 participant each.
eParticipants could have >1 AE leading to withdrawal.
fChills (drug related), hepatitis C virus infection, and pain (drug related).
gAcute kidney injury, coronary artery disease, deep venous thrombosis, drug abuse, eosinophilic granulomatosis with polyangiitis, epilepsy, fatigue, hepatitis C virus infection, hypoesthesia, lymphadenopathy, mesenteric vein thrombosis, metabolic acidosis, motor neuron disease, muscular weakness, portal vein thrombosis, respiratory tract infection, rhabdomyolysis, splenic vein thrombosis, squamous cell carcinoma of the lung, suicide attempt, and toxicity to various agents (all not drug related). Abdominal pain, adjustment disorder with depressed mood, chest pain, dyspnea, flushing, myocardial infarction, prolonged QT interval, psychotic disorder, rash, and sinus tachycardia (all drug related).
hBack pain, conjunctival hyperemia, erythema, and papular urticaria (all drug related).
iInjection site pain.