Serious adverse events
|
Botulinum Toxin Type A 300U Treatment Cycle 1 |
Botulinum Toxin Type A 200U Treatment Cycle 1 |
Botulinum Toxin Type A 300U Treatment Cycle 2 |
Botulinum Toxin Type A 200U Treatment Cycle 2 |
Botulinum Toxin Type A 300U Treatment Cycle 3 |
Botulinum Toxin Type A 200U Treatment Cycle 3 |
Botulinum Toxin Type A 300U Treatment Cycle 4 |
Botulinum Toxin Type A 200U Treatment Cycle 4 |
Botulinum Toxin Type A 300U Treatment Cycle 5 |
Botulinum Toxin Type A 200U Treatment Cycle 5 |
Botulinum Toxin Type A 300U Treatment Cycle 6 |
Botulinum Toxin Type A 200U Treatment Cycle 6 |
Botulinum Toxin Type A 300U Treatment Cycle 7 |
Botulinum Toxin Type A 200U Treatment Cycle 7 |
Botulinum Toxin Type A 200U Treatment Cycle 8 |
Botulinum Toxin Type A 200U Treatment Cycle 9 |
Botulinum Toxin Type A 200U Treatment Cycle 10 |
Botulinum Toxin Type A 200U Treatment Cycle 11 |
Botulinum Toxin Type A 200U Treatment Cycle 12 |
Total subjects affected by serious adverse events
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
28 / 185 (15.14%) |
35 / 203 (17.24%) |
26 / 163 (15.95%) |
21 / 187 (11.23%) |
20 / 119 (16.81%) |
19 / 175 (10.86%) |
11 / 69 (15.94%) |
20 / 153 (13.07%) |
5 / 34 (14.71%) |
11 / 110 (10.00%) |
0 / 16 (0.00%) |
9 / 70 (12.86%) |
0 / 8 (0.00%) |
6 / 48 (12.50%) |
0 / 36 (0.00%) |
2 / 22 (9.09%) |
1 / 11 (9.09%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
number of deaths (all causes)
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
number of deaths resulting from adverse events
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basal Cell Carcinoma
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 185 (0.54%) |
0 / 203 (0.00%) |
0 / 163 (0.00%) |
1 / 187 (0.53%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
2 / 34 (5.88%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Prostate cancer
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional description: Males Only
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 185 (0.54%) |
0 / 203 (0.00%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Breast Cancer
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
2 / 203 (0.99%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Squamous Cell Carcinoma
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
1 / 203 (0.49%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Thyroid Neoplasm
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
1 / 203 (0.49%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Squamous Cell Carcinoma of Skin
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
1 / 119 (0.84%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
1 / 153 (0.65%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Invasive Ductal Breast Carcinoma
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
1 / 153 (0.65%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Glioblastoma
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
1 / 110 (0.91%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Uterine Leiomyoma
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional description: Females Only
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
1 / 48 (2.08%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vascular disorders
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hypertension
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
1 / 163 (0.61%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
2 / 175 (1.14%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral Ischaemia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
0 / 163 (0.00%) |
1 / 187 (0.53%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Deep Vein Thrombosis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
1 / 119 (0.84%) |
1 / 175 (0.57%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral Vascular Disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
1 / 119 (0.84%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Surgical and medical procedures
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Abortion Induced
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional description: Females Only
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
1 / 203 (0.49%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
1 / 110 (0.91%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
General disorders and administration site conditions
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adverse Drug Reaction
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 185 (0.54%) |
0 / 203 (0.00%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Non-Cardiac Chest Pain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
alternative assessment type: Non-systematic
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
2 / 203 (0.99%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
1 / 70 (1.43%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
1 / 11 (9.09%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pyrexia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
alternative assessment type: Non-systematic
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
1 / 203 (0.49%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
1 / 175 (0.57%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Device Dislocation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
1 / 163 (0.61%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Oedema Peripheral
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
alternative assessment type: Non-systematic
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
1 / 163 (0.61%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
1 / 153 (0.65%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Device Deployment Issue
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
1 / 175 (0.57%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Impaired Healing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
alternative assessment type: Non-systematic
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
1 / 175 (0.57%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Device Malfunction
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
1 / 153 (0.65%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Immune system disorders
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Anaphylactic Reaction
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
alternative assessment type: Non-systematic
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
1 / 175 (0.57%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Reproductive system and breast disorders
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Epididymitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional description: Males Only
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
1 / 203 (0.49%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
1 / 175 (0.57%) |
1 / 69 (1.45%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pelvic Prolapse
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
1 / 163 (0.61%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Erectile Dysfunction
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional description: Males Only
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
1 / 119 (0.84%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory, thoracic and mediastinal disorders
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Asthma
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
alternative assessment type: Non-systematic
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
1 / 203 (0.49%) |
1 / 163 (0.61%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
1 / 69 (1.45%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory Failure
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
1 / 163 (0.61%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
1 / 175 (0.57%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia Aspiration
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
alternative assessment type: Non-systematic
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
0 / 163 (0.00%) |
1 / 187 (0.53%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pneumothorax
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
0 / 163 (0.00%) |
1 / 187 (0.53%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary Embolism
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
1 / 175 (0.57%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Psychiatric disorders
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mental Status Changes
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
alternative assessment type: Non-systematic
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
1 / 203 (0.49%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
1 / 175 (0.57%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
1 / 70 (1.43%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Acute Psychosis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
1 / 163 (0.61%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Depression
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
alternative assessment type: Non-systematic
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
1 / 163 (0.61%) |
0 / 187 (0.00%) |
1 / 119 (0.84%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Confusional State
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
alternative assessment type: Non-systematic
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
1 / 175 (0.57%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Investigations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Urine Cytology Abnormal
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
1 / 203 (0.49%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Medical observation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
alternative assessment type: Non-systematic
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
1 / 110 (0.91%) |
0 / 16 (0.00%) |
1 / 70 (1.43%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Injury, poisoning and procedural complications
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Craniocerebral Injury
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
alternative assessment type: Non-systematic
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 185 (0.54%) |
0 / 203 (0.00%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tendon Rupture
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
alternative assessment type: Non-systematic
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 185 (0.54%) |
0 / 203 (0.00%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Concussion
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
1 / 203 (0.49%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Fall
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
alternative assessment type: Non-systematic
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
1 / 203 (0.49%) |
1 / 163 (0.61%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Forearm Fracture
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
1 / 203 (0.49%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Incisional Hernia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
1 / 203 (0.49%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lower Limb Fracture
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
1 / 203 (0.49%) |
0 / 163 (0.00%) |
1 / 187 (0.53%) |
0 / 119 (0.00%) |
1 / 175 (0.57%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Overdose
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
1 / 203 (0.49%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Femur fracture
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
1 / 163 (0.61%) |
1 / 187 (0.53%) |
0 / 119 (0.00%) |
1 / 175 (0.57%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hip Fracture
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
0 / 163 (0.00%) |
1 / 187 (0.53%) |
0 / 119 (0.00%) |
1 / 175 (0.57%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tibia Fracture
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
0 / 163 (0.00%) |
1 / 187 (0.53%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
1 / 69 (1.45%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Joint Dislocation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
alternative assessment type: Non-systematic
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
1 / 119 (0.84%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Spinal Compression Fracture
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
1 / 175 (0.57%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Scar
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
alternative assessment type: Non-systematic
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
1 / 69 (1.45%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Scrotal Haematoma
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional description: Males Only
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
alternative assessment type: Non-systematic
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
1 / 69 (1.45%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Post Procedural Haemorrhage
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
alternative assessment type: Non-systematic
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
1 / 110 (0.91%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Foot Fracture
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
1 / 48 (2.08%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ankle Fracture
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
1 / 22 (4.55%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac disorders
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Myocardial Infarction
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 185 (0.54%) |
0 / 203 (0.00%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Acute myocardial infarction
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
1 / 203 (0.49%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Atrioventricular Block
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
1 / 203 (0.49%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Angina Pectoris
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
alternative assessment type: Non-systematic
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
0 / 163 (0.00%) |
1 / 187 (0.53%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
1 / 70 (1.43%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Atrial Fibrillation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
1 / 175 (0.57%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Arrhythmia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
1 / 153 (0.65%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Nervous system disorders
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Multiple Sclerosis Relapse
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
alternative assessment type: Non-systematic
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
4 / 185 (2.16%) |
4 / 203 (1.97%) |
4 / 163 (2.45%) |
0 / 187 (0.00%) |
3 / 119 (2.52%) |
3 / 175 (1.71%) |
4 / 69 (5.80%) |
2 / 153 (1.31%) |
1 / 34 (2.94%) |
1 / 110 (0.91%) |
0 / 16 (0.00%) |
3 / 70 (4.29%) |
0 / 8 (0.00%) |
2 / 48 (4.17%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
0 / 4 |
0 / 0 |
0 / 3 |
0 / 3 |
0 / 4 |
0 / 2 |
0 / 1 |
0 / 1 |
0 / 0 |
0 / 3 |
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Muscle Spasticity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
alternative assessment type: Non-systematic
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 185 (0.54%) |
0 / 203 (0.00%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cerebrovascular Accident
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
1 / 203 (0.49%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ischaemic Stroke
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
1 / 203 (0.49%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Myasthenia Gravis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
1 / 203 (0.49%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Multiple Sclerosis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
2 / 163 (1.23%) |
0 / 187 (0.00%) |
1 / 119 (0.84%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Paraparesis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
1 / 163 (0.61%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Convulsion
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
alternative assessment type: Non-systematic
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
0 / 163 (0.00%) |
1 / 187 (0.53%) |
1 / 119 (0.84%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Epilepsy
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
0 / 163 (0.00%) |
1 / 187 (0.53%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cervical myelopathy
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
1 / 153 (0.65%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Spinal Cord Compression
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
1 / 110 (0.91%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Syncope
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
alternative assessment type: Non-systematic
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
1 / 48 (2.08%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Blood and lymphatic system disorders
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Neutropenia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 185 (0.54%) |
0 / 203 (0.00%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Eye disorders
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vision Blurred
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
alternative assessment type: Non-systematic
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
0 / 163 (0.00%) |
1 / 187 (0.53%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal disorders
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intestinal Obstruction
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
2 / 185 (1.08%) |
0 / 203 (0.00%) |
1 / 163 (0.61%) |
0 / 187 (0.00%) |
1 / 119 (0.84%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Enterocolitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 185 (0.54%) |
0 / 203 (0.00%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Umbilical Hernia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 185 (0.54%) |
0 / 203 (0.00%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
1 / 153 (0.65%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Enterocutaneous Fistula
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
1 / 203 (0.49%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Faecaloma
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
1 / 203 (0.49%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal pain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
alternative assessment type: Non-systematic
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
1 / 163 (0.61%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
1 / 70 (1.43%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Colitis Ischaemic
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
1 / 163 (0.61%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diarrhoea
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
alternative assessment type: Non-systematic
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
1 / 163 (0.61%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
1 / 175 (0.57%) |
0 / 69 (0.00%) |
1 / 153 (0.65%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
1 / 70 (1.43%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhoidal Haemorrhage
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
alternative assessment type: Non-systematic
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
1 / 163 (0.61%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Large Intestine Perforation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
1 / 163 (0.61%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lower Gastrointestinal Haemorrhage
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
1 / 163 (0.61%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Melaena
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
alternative assessment type: Non-systematic
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
1 / 163 (0.61%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Small Intestinal Obstruction
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
1 / 163 (0.61%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Volvulus
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
1 / 163 (0.61%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Constipation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
alternative assessment type: Non-systematic
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
0 / 163 (0.00%) |
1 / 187 (0.53%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
1 / 110 (0.91%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hepatobiliary disorders
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cholecystitis Acute
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
1 / 203 (0.49%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cholecystitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
1 / 153 (0.65%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Skin and subcutaneous tissue disorders
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Decubitus Ulcer
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
alternative assessment type: Non-systematic
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
2 / 185 (1.08%) |
4 / 203 (1.97%) |
1 / 163 (0.61%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
2 / 175 (1.14%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
1 / 34 (2.94%) |
1 / 110 (0.91%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
1 / 48 (2.08%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Renal and urinary disorders
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Urinary Retention
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
alternative assessment type: Non-systematic
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 185 (0.54%) |
0 / 203 (0.00%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urethral Haemorrhage
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
1 / 203 (0.49%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Stress Urinary Incontinence
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
alternative assessment type: Non-systematic
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
1 / 163 (0.61%) |
1 / 187 (0.53%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bladder Neck Obstruction
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
1 / 163 (0.61%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haematuria
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
1 / 163 (0.61%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
1 / 153 (0.65%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urethral Stenosis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
1 / 163 (0.61%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Nephrolithiasis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
0 / 163 (0.00%) |
1 / 187 (0.53%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Neurogenic Bladder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
1 / 175 (0.57%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urinary Incontinence
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
alternative assessment type: Non-systematic
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
1 / 69 (1.45%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hydronephrosis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
1 / 153 (0.65%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hydroureter
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
1 / 153 (0.65%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Endocrine disorders
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hyperthyroidism
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
1 / 69 (1.45%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Musculoskeletal and connective tissue disorders
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Lumbar Spinal Stenosis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
2 / 185 (1.08%) |
0 / 203 (0.00%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Spondylolisthesis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 185 (0.54%) |
1 / 203 (0.49%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
1 / 153 (0.65%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Foot Deformity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
alternative assessment type: Non-systematic
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 185 (0.54%) |
0 / 203 (0.00%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intervertebral Disc Protrusion
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 185 (0.54%) |
0 / 203 (0.00%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Muscular Weakness
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
alternative assessment type: Non-systematic
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
2 / 203 (0.99%) |
0 / 163 (0.00%) |
1 / 187 (0.53%) |
0 / 119 (0.00%) |
1 / 175 (0.57%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Back Pain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
alternative assessment type: Non-systematic
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
1 / 203 (0.49%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vertebral Foraminal Stenosis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
1 / 203 (0.49%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bone Pain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
alternative assessment type: Non-systematic
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
1 / 163 (0.61%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lupus-Like Syndrome
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
1 / 163 (0.61%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Costochondritis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
alternative assessment type: Non-systematic
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
0 / 163 (0.00%) |
1 / 187 (0.53%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Exostosis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
0 / 163 (0.00%) |
1 / 187 (0.53%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Osteoarthritis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
alternative assessment type: Non-systematic
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
0 / 163 (0.00%) |
1 / 187 (0.53%) |
1 / 119 (0.84%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
1 / 153 (0.65%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Arthralgia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
alternative assessment type: Non-systematic
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
1 / 175 (0.57%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cervical Spinal Stenosis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
1 / 153 (0.65%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rotator Cuff Syndrome
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
alternative assessment type: Non-systematic
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
1 / 153 (0.65%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Mobility Decreased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
alternative assessment type: Non-systematic
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
1 / 48 (2.08%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Infections and infestations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Urinary Tract Infection
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
alternative assessment type: Non-systematic
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
7 / 185 (3.78%) |
5 / 203 (2.46%) |
3 / 163 (1.84%) |
1 / 187 (0.53%) |
3 / 119 (2.52%) |
2 / 175 (1.14%) |
0 / 69 (0.00%) |
1 / 153 (0.65%) |
1 / 34 (2.94%) |
1 / 110 (0.91%) |
0 / 16 (0.00%) |
1 / 70 (1.43%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
2 / 7 |
3 / 5 |
1 / 3 |
0 / 1 |
0 / 3 |
1 / 2 |
0 / 0 |
0 / 1 |
0 / 1 |
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 185 (0.54%) |
1 / 203 (0.49%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
1 / 175 (0.57%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
1 / 110 (0.91%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Clostridium Difficile Colitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 185 (0.54%) |
0 / 203 (0.00%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pyelonephritis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 185 (0.54%) |
0 / 203 (0.00%) |
0 / 163 (0.00%) |
3 / 187 (1.60%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 3 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Upper Respiratory Tract Infection
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
alternative assessment type: Non-systematic
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 185 (0.54%) |
0 / 203 (0.00%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
1 / 70 (1.43%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urinary Tract Infection Bacterial
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 185 (0.54%) |
0 / 203 (0.00%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urosepsis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 185 (0.54%) |
0 / 203 (0.00%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
1 / 110 (0.91%) |
0 / 16 (0.00%) |
1 / 70 (1.43%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Wound Infection
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
alternative assessment type: Non-systematic
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 185 (0.54%) |
0 / 203 (0.00%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
1 / 175 (0.57%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Appendicitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
1 / 203 (0.49%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cellulitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
1 / 203 (0.49%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
1 / 153 (0.65%) |
0 / 34 (0.00%) |
1 / 110 (0.91%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Escherichia Sepsis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
1 / 203 (0.49%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Meningitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
1 / 203 (0.49%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Necrotising Fasciitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
1 / 203 (0.49%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
2 / 119 (1.68%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Paronychia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
alternative assessment type: Non-systematic
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
1 / 203 (0.49%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Sepsis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
1 / 203 (0.49%) |
0 / 163 (0.00%) |
1 / 187 (0.53%) |
2 / 119 (1.68%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Osteomyelitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
1 / 163 (0.61%) |
0 / 187 (0.00%) |
1 / 119 (0.84%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pyelonephritis Acute
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
1 / 163 (0.61%) |
0 / 187 (0.00%) |
1 / 119 (0.84%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
3 / 153 (1.96%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 3 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Systemic Candida
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
1 / 163 (0.61%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Localised Infection
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
alternative assessment type: Non-systematic
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
0 / 163 (0.00%) |
1 / 187 (0.53%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Abscess of Salivary Gland
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
alternative assessment type: Non-systematic
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
1 / 119 (0.84%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Skin Infection
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
alternative assessment type: Non-systematic
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
1 / 119 (0.84%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Device Related Infection
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
alternative assessment type: Non-systematic
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
1 / 175 (0.57%) |
1 / 69 (1.45%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bacteraemia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
1 / 153 (0.65%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Erysipelas
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
1 / 153 (0.65%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Parotitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
1 / 153 (0.65%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Viral Infection
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
alternative assessment type: Non-systematic
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
1 / 153 (0.65%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Post Procedural Infection
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
alternative assessment type: Non-systematic
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
1 / 110 (0.91%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Subcutaneous Abscess
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
1 / 22 (4.55%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Metabolism and nutrition disorders
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Obesity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
alternative assessment type: Non-systematic
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
1 / 203 (0.49%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
0 / 175 (0.00%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dehydration
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
alternative assessment type: Non-systematic
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
1 / 175 (0.57%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hyperkalaemia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
1 / 175 (0.57%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypoglycaemia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 185 (0.00%) |
0 / 203 (0.00%) |
0 / 163 (0.00%) |
0 / 187 (0.00%) |
0 / 119 (0.00%) |
1 / 175 (0.57%) |
0 / 69 (0.00%) |
0 / 153 (0.00%) |
0 / 34 (0.00%) |
0 / 110 (0.00%) |
0 / 16 (0.00%) |
0 / 70 (0.00%) |
0 / 8 (0.00%) |
0 / 48 (0.00%) |
0 / 36 (0.00%) |
0 / 22 (0.00%) |
0 / 11 (0.00%) |
0 / 5 (0.00%) |
0 / 2 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |