| . | Arm 1 . | Arm 2 . |
|---|---|---|
| Adverse event . | (N = 202) . | (N = 103) . |
| General disorders | ||
| Injection site reaction | 91 (45.0%) | 44 (42.7%) |
| Chills | 0 (0%) | 1 (1.0%) |
| Fatigue | 6 (3.0%) | 17 (16.5%) |
| Fever | 3 (1.5%) | 1 (1.0%) |
| Flu-like symptoms | 26 (12.9%) | 1 (1.0%) |
| Pain | 1 (0.5%) | 0 (0%) |
| Nervous system related | ||
| Headache | 7 (3.5%) | 19a (18.4%) |
| Seizure | 0 (0%) | 2 (1.9%) |
| Dizziness | 2 (1.0%) | 0 (0%) |
| Insomnia | 4 (2.0%) | 0 (0%) |
| Gastrointestinal disorders | ||
| Nausea | 12 (5.9%) | 7 (6.8%) |
| Upset stomach | 1 (0.5%) | 0 (0%) |
| Vomiting | 3 (1.5%) | 7 (6.8%) |
| Dyspepsia | 1 (0.5%) | 0 (0%) |
| Skin disorder | ||
| Pruritus | 2 (1.0%) | 1 (1.0%) |
| Rash Maculo-Papular | 0 (0%) | 0 (0%) |
| Itching | 0 (0%) | 0 (0%) |
| Blood disorders | ||
| Leukopenia | 12a (5.9%) | 0 (0%) |
| Neutropenia | 2 (1.0%) | 0 (0%) |
| Lymphopenia | 12a (5.9%) | 0 (0%) |
| Laboratory results | ||
| ALT increase | 1 (0.5%) | 0 (0%) |
| AST increase | 0 (0%) | 0 (0%) |
| Respiratory disorder | ||
| Laryngeal inflammation | 0 (0%) | 0 (0%) |
| Cough | 0 (0%) | 0 (0%) |
| Wheezing | 0 (0%) | 0 (0%) |
| Sore throat | 1 (0.5%) | 0 (0%) |
| Musculoskeletal and connective tissue disorders | ||
| Pain in extremity | 4 (2.0%) | 0 (0%) |
| Arthralgia | 1 (0.5%) | 0 (0%) |
| Body aches | 1 (0.5%) | 0 (0%) |
| Renal disorders | ||
| Urinary frequency | 1 (0.5%) | 0 (0%) |
| Metabolism and nutrition disorders | ||
| Anorexia | 0 (0%) | 2 (1.9%) |
| . | Arm 1 . | Arm 2 . |
|---|---|---|
| Adverse event . | (N = 202) . | (N = 103) . |
| General disorders | ||
| Injection site reaction | 91 (45.0%) | 44 (42.7%) |
| Chills | 0 (0%) | 1 (1.0%) |
| Fatigue | 6 (3.0%) | 17 (16.5%) |
| Fever | 3 (1.5%) | 1 (1.0%) |
| Flu-like symptoms | 26 (12.9%) | 1 (1.0%) |
| Pain | 1 (0.5%) | 0 (0%) |
| Nervous system related | ||
| Headache | 7 (3.5%) | 19a (18.4%) |
| Seizure | 0 (0%) | 2 (1.9%) |
| Dizziness | 2 (1.0%) | 0 (0%) |
| Insomnia | 4 (2.0%) | 0 (0%) |
| Gastrointestinal disorders | ||
| Nausea | 12 (5.9%) | 7 (6.8%) |
| Upset stomach | 1 (0.5%) | 0 (0%) |
| Vomiting | 3 (1.5%) | 7 (6.8%) |
| Dyspepsia | 1 (0.5%) | 0 (0%) |
| Skin disorder | ||
| Pruritus | 2 (1.0%) | 1 (1.0%) |
| Rash Maculo-Papular | 0 (0%) | 0 (0%) |
| Itching | 0 (0%) | 0 (0%) |
| Blood disorders | ||
| Leukopenia | 12a (5.9%) | 0 (0%) |
| Neutropenia | 2 (1.0%) | 0 (0%) |
| Lymphopenia | 12a (5.9%) | 0 (0%) |
| Laboratory results | ||
| ALT increase | 1 (0.5%) | 0 (0%) |
| AST increase | 0 (0%) | 0 (0%) |
| Respiratory disorder | ||
| Laryngeal inflammation | 0 (0%) | 0 (0%) |
| Cough | 0 (0%) | 0 (0%) |
| Wheezing | 0 (0%) | 0 (0%) |
| Sore throat | 1 (0.5%) | 0 (0%) |
| Musculoskeletal and connective tissue disorders | ||
| Pain in extremity | 4 (2.0%) | 0 (0%) |
| Arthralgia | 1 (0.5%) | 0 (0%) |
| Body aches | 1 (0.5%) | 0 (0%) |
| Renal disorders | ||
| Urinary frequency | 1 (0.5%) | 0 (0%) |
| Metabolism and nutrition disorders | ||
| Anorexia | 0 (0%) | 2 (1.9%) |
aGrade 3 adverse event
| . | Arm 1 . | Arm 2 . |
|---|---|---|
| Adverse event . | (N = 202) . | (N = 103) . |
| General disorders | ||
| Injection site reaction | 91 (45.0%) | 44 (42.7%) |
| Chills | 0 (0%) | 1 (1.0%) |
| Fatigue | 6 (3.0%) | 17 (16.5%) |
| Fever | 3 (1.5%) | 1 (1.0%) |
| Flu-like symptoms | 26 (12.9%) | 1 (1.0%) |
| Pain | 1 (0.5%) | 0 (0%) |
| Nervous system related | ||
| Headache | 7 (3.5%) | 19a (18.4%) |
| Seizure | 0 (0%) | 2 (1.9%) |
| Dizziness | 2 (1.0%) | 0 (0%) |
| Insomnia | 4 (2.0%) | 0 (0%) |
| Gastrointestinal disorders | ||
| Nausea | 12 (5.9%) | 7 (6.8%) |
| Upset stomach | 1 (0.5%) | 0 (0%) |
| Vomiting | 3 (1.5%) | 7 (6.8%) |
| Dyspepsia | 1 (0.5%) | 0 (0%) |
| Skin disorder | ||
| Pruritus | 2 (1.0%) | 1 (1.0%) |
| Rash Maculo-Papular | 0 (0%) | 0 (0%) |
| Itching | 0 (0%) | 0 (0%) |
| Blood disorders | ||
| Leukopenia | 12a (5.9%) | 0 (0%) |
| Neutropenia | 2 (1.0%) | 0 (0%) |
| Lymphopenia | 12a (5.9%) | 0 (0%) |
| Laboratory results | ||
| ALT increase | 1 (0.5%) | 0 (0%) |
| AST increase | 0 (0%) | 0 (0%) |
| Respiratory disorder | ||
| Laryngeal inflammation | 0 (0%) | 0 (0%) |
| Cough | 0 (0%) | 0 (0%) |
| Wheezing | 0 (0%) | 0 (0%) |
| Sore throat | 1 (0.5%) | 0 (0%) |
| Musculoskeletal and connective tissue disorders | ||
| Pain in extremity | 4 (2.0%) | 0 (0%) |
| Arthralgia | 1 (0.5%) | 0 (0%) |
| Body aches | 1 (0.5%) | 0 (0%) |
| Renal disorders | ||
| Urinary frequency | 1 (0.5%) | 0 (0%) |
| Metabolism and nutrition disorders | ||
| Anorexia | 0 (0%) | 2 (1.9%) |
| . | Arm 1 . | Arm 2 . |
|---|---|---|
| Adverse event . | (N = 202) . | (N = 103) . |
| General disorders | ||
| Injection site reaction | 91 (45.0%) | 44 (42.7%) |
| Chills | 0 (0%) | 1 (1.0%) |
| Fatigue | 6 (3.0%) | 17 (16.5%) |
| Fever | 3 (1.5%) | 1 (1.0%) |
| Flu-like symptoms | 26 (12.9%) | 1 (1.0%) |
| Pain | 1 (0.5%) | 0 (0%) |
| Nervous system related | ||
| Headache | 7 (3.5%) | 19a (18.4%) |
| Seizure | 0 (0%) | 2 (1.9%) |
| Dizziness | 2 (1.0%) | 0 (0%) |
| Insomnia | 4 (2.0%) | 0 (0%) |
| Gastrointestinal disorders | ||
| Nausea | 12 (5.9%) | 7 (6.8%) |
| Upset stomach | 1 (0.5%) | 0 (0%) |
| Vomiting | 3 (1.5%) | 7 (6.8%) |
| Dyspepsia | 1 (0.5%) | 0 (0%) |
| Skin disorder | ||
| Pruritus | 2 (1.0%) | 1 (1.0%) |
| Rash Maculo-Papular | 0 (0%) | 0 (0%) |
| Itching | 0 (0%) | 0 (0%) |
| Blood disorders | ||
| Leukopenia | 12a (5.9%) | 0 (0%) |
| Neutropenia | 2 (1.0%) | 0 (0%) |
| Lymphopenia | 12a (5.9%) | 0 (0%) |
| Laboratory results | ||
| ALT increase | 1 (0.5%) | 0 (0%) |
| AST increase | 0 (0%) | 0 (0%) |
| Respiratory disorder | ||
| Laryngeal inflammation | 0 (0%) | 0 (0%) |
| Cough | 0 (0%) | 0 (0%) |
| Wheezing | 0 (0%) | 0 (0%) |
| Sore throat | 1 (0.5%) | 0 (0%) |
| Musculoskeletal and connective tissue disorders | ||
| Pain in extremity | 4 (2.0%) | 0 (0%) |
| Arthralgia | 1 (0.5%) | 0 (0%) |
| Body aches | 1 (0.5%) | 0 (0%) |
| Renal disorders | ||
| Urinary frequency | 1 (0.5%) | 0 (0%) |
| Metabolism and nutrition disorders | ||
| Anorexia | 0 (0%) | 2 (1.9%) |
aGrade 3 adverse event
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