System Organ Class |
Dextran 40 |
Dextran 40, 100 mannitol |
Dextran 75 |
Cardiac disorder |
Bradycardia (6) |
Decreased heart Rhythm (1) |
Atrial fibrillation (1) |
|
Cardiac disorder (13) |
Tachycardia (6) |
Tachycardia (1) |
|
Palpitation (1) |
Heart race (1) |
Cardiac disorder (2) |
|
Tachycardia (28) |
|
|
Total |
48 |
8 |
4 |
Eye disorders |
Conjuctivitis (2) |
NR |
NR |
|
Eye burning (2) |
|
|
|
Pupil dilatation (1) |
|
|
Total |
5 |
0 |
0 |
General disorders |
Chills (88) |
Chills (10) |
Injection site reaction (1) |
|
Dead (1) |
Temperature increased (6) |
Chills (2) |
|
Dizziness (1) |
Pain (1) |
Temperature increased (3) |
|
Temperature changes (79) |
Injection site reaction (1) |
|
|
Head pressure (1) |
Fever (1) |
|
|
Pain (5) |
|
|
|
Hypotonie (3) |
|
|
|
Incompability (1) |
|
|
|
Lack of consciousness (2) |
|
|
Total |
181 |
19 |
6 |
Gastrointestinal disorders |
Vomiting (42) |
Stomach pain (1) |
Nausea (2) |
|
Stomach pain (2) |
Nausea (3) |
Vomiting (1) |
|
Nausea (29) |
Vomiting (2) |
|
|
Mouth blister (2) |
|
|
|
Hyperstomie (1) |
|
|
|
Diarrhea (4) |
|
|
Total |
80 |
6 |
3 |
Infections and infestations |
Flu symptoms (1) |
NR |
Pyrogen reaction (1) |
|
Pyrogen reaction (2) |
|
|
Total |
3 |
0 |
1 |
Investigations |
Blood pressure increased (10) |
Increased pulse (1) |
Decreased blood pressure (1) |
|
Pulse changes (3) |
Blood pressure changes (6) |
Hypertension (1) |
Total |
13 |
7 |
2 |
Immune system disorders |
Anaphylactic reaction/shock (25) |
Anaphylactic reaction/shock (4) |
Anaphylactic reaction/shock (11) |
Total |
25 |
4 |
11 |
Musculoskeletal disorders |
Muscle pain (24) |
Back pain (1) |
NR |
Total |
24 |
1 |
0 |
Nervous system disorders |
Parasthesies (2) |
Headache (3) |
Convulsions (1) |
|
Headache (4) |
Restlessness (1) |
|
|
Vertigo (1) |
Uterus contraction (1) |
|
|
Restlessness (2) |
|
|
|
Tingling (2) |
|
|
|
Trembling (1) |
|
|
Total |
12 |
5 |
1 |
Psychiatric disorders |
Psychiatric disorder (2) |
Anxiety (1) |
Anxiety (1) |
Total |
2 |
1 |
1 |
Renal and urinary disorders |
Kidney pain (3) |
Kidney pain (2) |
NR |
Total |
3 |
2 |
0 |
Respiratory disorders |
Bronchospasm (74) |
Lung oedema (2) |
Difficulty breathing (11) |
|
Cough (3) |
Difficulty breathing (8) |
|
|
Cyanosis (17) |
Cyanosis (2) |
|
|
Lung oedema (7) |
|
|
Total |
101 |
12 |
1 |
Skin and subcutaneous disorders |
Urticaria (22) |
Skin redness (3) |
Erythema (1) |
|
Rash (2) |
Urticaria (1) |
Hot flashes (1) |
|
Pruritus (26) |
Exanthem (5) |
Lip oedema (1) |
|
Swelling (3) |
Hot flashes (1) |
Rash (3) |
|
Erythem (5) |
Oedema (3) |
|
|
Oedema (10) |
|
|
|
Blister (8) |
|
|
|
Hot flashes (1) |
|
|
|
Exanthem (26) |
|
|
|
Itching (5) |
|
|
Total |
108 |
13 |
6 |
Vascular disorders |
Circulatory collaps/schock (39) |
Circulatory collaps/schock (4) |
NR |
Total |
39 |
4 |
0 |
Total ADRs (N) |
645 |
82 |
46 |