| Total No. AEs |
18 |
28 |
|
Total No. SAEs (marked with
*) |
5 |
2 |
|
Total No. SADR (marked with
§) |
0 |
1 |
| Blood and lymphatic system disorders |
|
|
| ∙ Anemia |
0 |
2 |
| Gastrointestinal disorders |
|
|
| ∙ Abdominal pain |
3 |
1 |
| ∙ Gastrointestinal hemorrhage |
0 |
1*§
|
| ∙ Constipation |
1* |
0 |
| ∙ Diarrhea |
1* |
2 |
| ∙ Mucous stools |
1 |
0 |
| ∙ Nausea |
1 |
1 |
| ∙ Vomiting |
1 |
1 |
| General disorders and administration site conditions |
|
|
| ∙ Asthenia |
0 |
2 (1*) |
| ∙ Device dislocation* |
1* |
0 |
| ∙ Fatigue |
1 |
1 |
| ∙ General physical health deterioration |
0 |
1 |
| ∙ Pyrexia |
1 |
2 |
| Hepatobiliary disorders |
|
|
| ∙ Cholangitis |
1* |
0 |
| ∙ Cholestasis |
1* |
0 |
| Investigations |
|
|
| ∙ Blood Creatinine increased |
0 |
1 |
| ∙ Blood fibrinogen increased |
0 |
1 |
| ∙ Creatinine renal clearance decreased |
0 |
1 |
| ∙ ECOG performance status worsened |
2 |
1 |
| ∙ Hepatic enzyme increased |
0 |
1 |
| ∙ Inflammatory marker increased |
1 |
0 |
| ∙ International normalized ratio increased |
0 |
1 |
| Metabolism and nutrition disorders |
|
|
| ∙ Catabolic state |
0 |
1 |
| ∙ Malnutrition |
0 |
1 |
| Musculoskeletal and connective tissue disorders |
|
|
| ∙ Growing pains |
0 |
1 |
| Nervous system disorders |
|
|
| ∙ Dizziness |
0 |
1 |
| Renal and urinary disorders |
|
|
| ∙ Bladder Pain |
0 |
1 |
| Respiratory, thoracic and mediastinal disorders |
|
|
| ∙ Cough |
0 |
1 |
| ∙ Dyspnea |
1 |
0 |
| Skin and subcutaneous tissue disorders |
|
|
| ∙ Dry skin |
1 |
0 |
| ∙ Night sweats |
0 |
1 |
| Vascular disorders |
|
|
| ∙ Hypertension |
0 |
1 |
