Safety data
. | No. events by dose level*(no. of patients†) . | . | . | All patients, n = 9 . | ||
|---|---|---|---|---|---|---|
| Disorders (details) . | 3 × 109 tp's, n = 3 . | 3 × 1010 tp's, n = 3 . | 3 × 1011 tp's, n = 3 . | . | ||
| General disorders and the administration site conditions | 37 (3) | 23 (3) | 54 (3) | 114 (9) | ||
| Injection site reactions (burning, pain, edema, induration, erythema, vesicles, movement impairment, pruritus, others) | 19 (3‡ | 10 (2‡ | 30 (3‡‡ | 59 (8) | ||
| Asthenic conditions (fatigue, malaise) | 13 (3) | 4 (3) | 6 (3) | 23 (9) | ||
| Body temperature perception (chills, cold sensation) | 0 (0) | 4 (2) | 6 (3) | 10 (5) | ||
| Febrile disorders (fever) | 5 (2) | 5 (2) | 9 (3) | 19 (7) | ||
| General signs and symptoms (dyspnea) | 0 (0) | 0 (0) | 3 (1) | 3 (1) | ||
| Blood and lymphatic system (lymphadenopathy) | 0 (0) | 0 (0) | 1 (1) | 1 (1) | ||
| Cardiac (arrhythmia, tachycardia) | 0 (0) | 1 (1) | 1 (1) | 2 (2) | ||
| Gastrointestinal (diarrhea, nausea) | 3 (1) | 0 (0) | 2 (2) | 5 (3) | ||
| Musculoskeletal and connective tissue (limb pain) | 0 (0) | 2 (2) | 3 (2) | 5 (4) | ||
| Nervous system (dizziness, headache) | 1 (1) | 3 (2) | 9 (3) | 13 (6) | ||
| Psychiatric (sleep disorders) | 0 (0) | 0 (0) | 2 (2) | 2 (2) | ||
| Respiratory (nose bleeding, cough) | 3 (2) | 0 (0) | 1 (1) | 4 (3) | ||
| Skin (exfoliative dermatitis, sweating, erythema, rash, fissures, pruritus) | 1 (1) | 7 (2) | 2 (1) | 10 (4) | ||
| Vascular (flushing) | 0 (0) | 2 (1) | 2 (2) | 4 (3) | ||
. | No. events by dose level*(no. of patients†) . | . | . | All patients, n = 9 . | ||
|---|---|---|---|---|---|---|
| Disorders (details) . | 3 × 109 tp's, n = 3 . | 3 × 1010 tp's, n = 3 . | 3 × 1011 tp's, n = 3 . | . | ||
| General disorders and the administration site conditions | 37 (3) | 23 (3) | 54 (3) | 114 (9) | ||
| Injection site reactions (burning, pain, edema, induration, erythema, vesicles, movement impairment, pruritus, others) | 19 (3‡ | 10 (2‡ | 30 (3‡‡ | 59 (8) | ||
| Asthenic conditions (fatigue, malaise) | 13 (3) | 4 (3) | 6 (3) | 23 (9) | ||
| Body temperature perception (chills, cold sensation) | 0 (0) | 4 (2) | 6 (3) | 10 (5) | ||
| Febrile disorders (fever) | 5 (2) | 5 (2) | 9 (3) | 19 (7) | ||
| General signs and symptoms (dyspnea) | 0 (0) | 0 (0) | 3 (1) | 3 (1) | ||
| Blood and lymphatic system (lymphadenopathy) | 0 (0) | 0 (0) | 1 (1) | 1 (1) | ||
| Cardiac (arrhythmia, tachycardia) | 0 (0) | 1 (1) | 1 (1) | 2 (2) | ||
| Gastrointestinal (diarrhea, nausea) | 3 (1) | 0 (0) | 2 (2) | 5 (3) | ||
| Musculoskeletal and connective tissue (limb pain) | 0 (0) | 2 (2) | 3 (2) | 5 (4) | ||
| Nervous system (dizziness, headache) | 1 (1) | 3 (2) | 9 (3) | 13 (6) | ||
| Psychiatric (sleep disorders) | 0 (0) | 0 (0) | 2 (2) | 2 (2) | ||
| Respiratory (nose bleeding, cough) | 3 (2) | 0 (0) | 1 (1) | 4 (3) | ||
| Skin (exfoliative dermatitis, sweating, erythema, rash, fissures, pruritus) | 1 (1) | 7 (2) | 2 (1) | 10 (4) | ||
| Vascular (flushing) | 0 (0) | 2 (1) | 2 (2) | 4 (3) | ||