SAFETY profile
Adverse Reaction1
N=137
All Grades (%)
Grade 3-4 (%)
| Vascular disorders | ||
|---|---|---|
| Hot flusha | 50 | 0 |
| Hypertensionb | 15 | 0 |
| General disorders and administration site conditions | ||
| Injection site reactionsc | 11 | 0 |
| Fatigued | 10 | 0 |
| Infections and infestations | ||
| Upper respiratory tract infectione | 11 | 0 |
| Musculoskeletal and connective tissue disorders | ||
| Musculoskeletal painf | 11 | 0 |
| Pain in extremity | 10 | 0 |
| Arthralgia | 7 | 0 |
| Renal and urinary disorders | ||
| Micturition urgencyg | 6 | 0 |
| Nocturia | 6 | 0 |
| Nervous system disorders | ||
| Dizzinessh | 5 | 0.7 |
a Includes hot flush and flushing
b Includes hypertension, essential hypertension, and blood pressure increased
c Includes injection site pain, injection site erythema, injection site hemorrhage, injection site nodule, injection site paraesthesia, injection site pruritus, and injection site warmth
d Includes fatigue and asthenia
e Includes upper respiratory tract infection, sinusitis, and nasopharyngitis
f Includes musculoskeletal pain, back pain, and bone pain
g Includes micturition urgency and dysuria
h Includes dizziness, dizziness postural, vertigo, and vertigo positional
Serious adverse reactions occurred in 15% of patients who received CAMCEVI®, including 1% of patients who experienced subdural hematoma. Fatal adverse reactions occurred in 2% of patients, including cerebrovascular accident (0.7%) and pulmonary embolism (0.7%).1
The most common adverse reactions (≥10%) occurring during a median follow-up duration of 336 days were hot flush, hypertension, injection site reactions, upper respiratory tract infections, musculoskeletal pain, fatigue, and pain in extremity.1
| Adverse Reaction1 | |
|---|---|
| N=137 | |
| All Grades (%) | Grade 3-4 (%) |
| Vascular disorders | |
| Hot flusha | |
| 50 | 0 |
| Hypertensionb | |
| 15 | 0 |
| General disorders and administration site conditions | |
| Injection site reactionsc | |
| 11 | 0 |
| Fatigued | |
| 10 | 0 |
| Infections and infestations | |
| Upper respiratory tract infectione | |
| 11 | 0 |
| Musculoskeletal and connective tissue disorders | |
| Musculoskeletal painf | |
| 11 | 0 |
| Pain in extremity | |
| 10 | 0 |
| Arthralgia | |
| 7 | 0 |
| Renal and urinary disorders | |
| Micturition urgencyg | |
| 6 | 0 |
| Nocturia | |
| 6 | 0 |
| Nervous system disorders | |
| Dizzinessh | |
| 5 | 0.7 |
a Includes hot flush and flushing
b Includes hypertension, essential hypertension, and blood pressure increased
c Includes injection site pain, injection site erythema, injection site hemorrhage, injection site nodule, injection site paraesthesia, injection site pruritus, and injection site warmth
d Includes fatigue and asthenia
e Includes upper respiratory tract infection, sinusitis, and nasopharyngitis
f Includes musculoskeletal pain, back pain, and bone pain
g Includes micturition urgency and dysuria
h Includes dizziness, dizziness postural, vertigo, and vertigo positional
Serious adverse reactions occurred in 15% of patients who received CAMCEVI®, including 1% of patients who experienced subdural hematoma. Fatal adverse reactions occurred in 2% of patients, including cerebrovascular accident (0.7%) and pulmonary embolism (0.7%).1
The most common adverse reactions (≥10%) occurring during a median follow-up duration of 336 days were hot flush, hypertension, injection site reactions, upper respiratory tract infections, musculoskeletal pain, fatigue, and pain in extremity.1
