Time Frame |
Randomization Up To 48 Months
|
Adverse Event Reporting Description |
All randomized participants who received at least 1 dose of study drug.
|
|
Arm/Group Title
|
8 mg/kg Ramucirumab + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine
|
Placebo IV + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine
|
80 mg Merestinib + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine
|
Placebo Oral + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine
|
Arm/Group Description |
Participants received 8 mg/kg ramuc...
|
Participants received placebo (indi...
|
Participants received 80 mg meresti...
|
Participants received placebo (indi...
|
Arm/Group Description |
Participants received 8 mg/kg ramucirumab plus 25 mg/m² cisplatin and 1000 mg/m² gemcitabine IV on days 1 and 8, every 21 days (1 cycle). Participants may continue on study drug for up to 8 cycles (for cisplatin and gemcitabine therapy) or until disease progression, unacceptable toxicity, or other withdrawal criterion is met (for ramucirumab therapy).
|
Participants received placebo (indistinguishable and equivalent volume to ramucirumab) plus 25 mg/m² cisplatin and 1000 mg/m² gemcitabine IV on days 1 and 8, every 21 days (1 cycle). Participants may continue on study drug for up to 8 cycles (for cisplatin and gemcitabine therapy) or until disease progression, unacceptable toxicity, or other withdrawal criterion is met (for placebo therapy).
|
Participants received 80 mg merestinib orally each day, plus 25 mg/m² cisplatin and 1000 mg/m² gemcitabine IV on Days 1 and 8, every 21 days (1 cycle). Participants may continue on study drug for up to 8 cycles (for cisplatin and gemcitabine therapy) or until disease progression, unacceptable toxicity, or other withdrawal criterion is met (for merestinib therapy).
|
Participants received placebo (indistinguishable to merestinib) orally each day, plus 25 mg/m² cisplatin and 1000 mg/m² gemcitabine IV on Days 1 and 8, every 21 days. Participants may continue on study drug for up to 8 cycles (for cisplatin and gemcitabine therapy) or until disease progression, unacceptable toxicity, or other withdrawal criterion is met (for placebo therapy).
|
|
|
8 mg/kg Ramucirumab + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine
|
Placebo IV + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine
|
80 mg Merestinib + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine
|
Placebo Oral + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine
|
|
Affected / at Risk (%) |
|
Affected / at Risk (%) |
|
Affected / at Risk (%) |
|
Affected / at Risk (%) |
|
Total |
84/104 (80.77%)
|
|
34/52 (65.38%)
|
|
71/102 (69.61%)
|
|
38/48 (79.17%)
|
|
|
|
8 mg/kg Ramucirumab + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine
|
Placebo IV + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine
|
80 mg Merestinib + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine
|
Placebo Oral + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine
|
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Total |
53/104 (50.96%)
|
|
25/52 (48.08%)
|
|
56/102 (54.90%)
|
|
23/48 (47.92%)
|
|
Blood and lymphatic system disorders |
|
|
|
|
Anemia |
3/104 (2.88%)
|
3 |
2/52 (3.85%)
|
2 |
2/102 (1.96%)
|
2 |
1/48 (2.08%)
|
1 |
Disseminated intravascular coagulation |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
1 |
0/48 (0.00%)
|
0 |
Febrile neutropenia |
1/104 (0.96%)
|
1 |
2/52 (3.85%)
|
2 |
1/102 (0.98%)
|
1 |
2/48 (4.17%)
|
2 |
Neutropenia |
3/104 (2.88%)
|
3 |
1/52 (1.92%)
|
1 |
5/102 (4.90%)
|
5 |
0/48 (0.00%)
|
0 |
Pancytopenia |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
1 |
0/48 (0.00%)
|
0 |
Thrombocytopenia |
6/104 (5.77%)
|
7 |
3/52 (5.77%)
|
3 |
2/102 (1.96%)
|
2 |
3/48 (6.25%)
|
3 |
Cardiac disorders |
|
|
|
|
Acute coronary syndrome |
1/104 (0.96%)
|
1 |
1/52 (1.92%)
|
1 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Atrial fibrillation |
0/104 (0.00%)
|
0 |
3/52 (5.77%)
|
3 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Atrial flutter |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
1 |
0/48 (0.00%)
|
0 |
Atrioventricular block complete |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Cardiac arrest |
1/104 (0.96%)
|
1 |
1/52 (1.92%)
|
1 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Cardiac failure |
0/104 (0.00%)
|
0 |
1/52 (1.92%)
|
1 |
1/102 (0.98%)
|
1 |
0/48 (0.00%)
|
0 |
Myocardial infarction |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Supraventricular tachycardia |
0/104 (0.00%)
|
0 |
1/52 (1.92%)
|
1 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Tachycardia |
0/104 (0.00%)
|
0 |
1/52 (1.92%)
|
1 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Congenital, familial and genetic disorders |
|
|
|
|
Pyloric stenosis |
0/104 (0.00%)
|
0 |
1/52 (1.92%)
|
1 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Ear and labyrinth disorders |
|
|
|
|
Hypoacusis |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Vertigo |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Vestibular disorder |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
1 |
0/48 (0.00%)
|
0 |
Eye disorders |
|
|
|
|
Blindness unilateral |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Optic ischaemic neuropathy |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
1 |
0/48 (0.00%)
|
0 |
Gastrointestinal disorders |
|
|
|
|
Abdominal distension |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
1 |
0/48 (0.00%)
|
0 |
Abdominal pain |
2/104 (1.92%)
|
2 |
2/52 (3.85%)
|
2 |
4/102 (3.92%)
|
5 |
0/48 (0.00%)
|
0 |
Anastomotic ulcer perforation |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Ascites |
3/104 (2.88%)
|
4 |
0/52 (0.00%)
|
0 |
2/102 (1.96%)
|
2 |
2/48 (4.17%)
|
3 |
Constipation |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
1 |
0/48 (0.00%)
|
0 |
Diarrhoea |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
2/102 (1.96%)
|
2 |
0/48 (0.00%)
|
0 |
Duodenal ulcer |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Duodenal ulcer haemorrhage |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
1 |
0/48 (0.00%)
|
0 |
Gastric haemorrhage |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
1/48 (2.08%)
|
1 |
Gastritis erosive |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
1/48 (2.08%)
|
1 |
Gastrooesophageal reflux disease |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Haematemesis |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
1 |
0/48 (0.00%)
|
0 |
Ileus |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
1 |
0/48 (0.00%)
|
0 |
Impaired gastric emptying |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Inguinal hernia |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
1 |
0/48 (0.00%)
|
0 |
Intestinal obstruction |
2/104 (1.92%)
|
2 |
1/52 (1.92%)
|
1 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Intestinal perforation |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
1 |
0/48 (0.00%)
|
0 |
Mesenteric vein thrombosis |
0/104 (0.00%)
|
0 |
1/52 (1.92%)
|
1 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Nausea |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
2/102 (1.96%)
|
3 |
0/48 (0.00%)
|
0 |
Obstruction gastric |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
1/48 (2.08%)
|
1 |
Oesophageal ulcer |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Oesophageal varices haemorrhage |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
2/102 (1.96%)
|
2 |
0/48 (0.00%)
|
0 |
Rectal haemorrhage |
0/104 (0.00%)
|
0 |
1/52 (1.92%)
|
1 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Stomatitis |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
1 |
0/48 (0.00%)
|
0 |
Upper gastrointestinal haemorrhage |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
2/102 (1.96%)
|
2 |
0/48 (0.00%)
|
0 |
Vomiting |
3/104 (2.88%)
|
4 |
1/52 (1.92%)
|
1 |
4/102 (3.92%)
|
5 |
1/48 (2.08%)
|
1 |
General disorders |
|
|
|
|
Catheter site extravasation |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
1 |
0/48 (0.00%)
|
0 |
Death |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
1 |
0/48 (0.00%)
|
0 |
Device related thrombosis |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
1 |
0/48 (0.00%)
|
0 |
Fatigue |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
2/102 (1.96%)
|
2 |
0/48 (0.00%)
|
0 |
General physical health deterioration |
0/104 (0.00%)
|
0 |
1/52 (1.92%)
|
1 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Implant site haemorrhage |
0/104 (0.00%)
|
0 |
1/52 (1.92%)
|
1 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Localised oedema |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
1 |
0/48 (0.00%)
|
0 |
Multiple organ dysfunction syndrome |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
1/48 (2.08%)
|
1 |
Non-cardiac chest pain |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
1/48 (2.08%)
|
1 |
Oedema peripheral |
0/104 (0.00%)
|
0 |
1/52 (1.92%)
|
1 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Pyrexia |
5/104 (4.81%)
|
9 |
1/52 (1.92%)
|
1 |
4/102 (3.92%)
|
5 |
2/48 (4.17%)
|
4 |
Sudden death |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
1 |
0/48 (0.00%)
|
0 |
Hepatobiliary disorders |
|
|
|
|
Bile duct obstruction |
0/104 (0.00%)
|
0 |
1/52 (1.92%)
|
1 |
2/102 (1.96%)
|
2 |
0/48 (0.00%)
|
0 |
Bile duct stenosis |
0/104 (0.00%)
|
0 |
1/52 (1.92%)
|
1 |
0/102 (0.00%)
|
0 |
1/48 (2.08%)
|
1 |
Cholangitis |
5/104 (4.81%)
|
7 |
0/52 (0.00%)
|
0 |
2/102 (1.96%)
|
2 |
1/48 (2.08%)
|
1 |
Cholangitis acute |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
1 |
0/48 (0.00%)
|
0 |
Cholecystitis |
0/104 (0.00%)
|
0 |
1/52 (1.92%)
|
2 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Hyperbilirubinaemia |
0/104 (0.00%)
|
0 |
1/52 (1.92%)
|
1 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Hypertransaminasaemia |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
1 |
0/48 (0.00%)
|
0 |
Jaundice cholestatic |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
2/48 (4.17%)
|
2 |
Portal vein thrombosis |
1/104 (0.96%)
|
1 |
1/52 (1.92%)
|
1 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Venoocclusive liver disease |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
1 |
0/48 (0.00%)
|
0 |
Infections and infestations |
|
|
|
|
Abdominal infection |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Appendicitis |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
1 |
0/48 (0.00%)
|
0 |
Arthritis bacterial |
0/104 (0.00%)
|
0 |
1/52 (1.92%)
|
1 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Bacteraemia |
1/104 (0.96%)
|
1 |
1/52 (1.92%)
|
1 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Biliary tract infection |
3/104 (2.88%)
|
6 |
1/52 (1.92%)
|
1 |
2/102 (1.96%)
|
3 |
1/48 (2.08%)
|
1 |
Bronchitis |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
1/48 (2.08%)
|
1 |
Cellulitis |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
1 |
0/48 (0.00%)
|
0 |
Cholangitis infective |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Cholecystitis infective |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Clostridium difficile colitis |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Device related infection |
2/104 (1.92%)
|
2 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
1 |
0/48 (0.00%)
|
0 |
Escherichia bacteraemia |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
1 |
0/48 (0.00%)
|
0 |
Hepatic infection |
0/104 (0.00%)
|
0 |
1/52 (1.92%)
|
1 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Infection |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
1/48 (2.08%)
|
1 |
Influenza |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Klebsiella bacteraemia |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Large intestine infection |
0/104 (0.00%)
|
0 |
1/52 (1.92%)
|
1 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Liver abscess |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
2/102 (1.96%)
|
2 |
1/48 (2.08%)
|
1 |
Lower respiratory tract infection viral |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Lung infection |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
1 |
0/48 (0.00%)
|
0 |
Meningitis meningococcal |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
1/48 (2.08%)
|
1 |
Parotitis |
0/104 (0.00%)
|
0 |
1/52 (1.92%)
|
1 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Peritonitis bacterial |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Pneumonia |
1/104 (0.96%)
|
1 |
1/52 (1.92%)
|
1 |
1/102 (0.98%)
|
1 |
1/48 (2.08%)
|
2 |
Respiratory tract infection |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Respiratory tract infection viral |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
1 |
0/48 (0.00%)
|
0 |
Sepsis |
4/104 (3.85%)
|
5 |
1/52 (1.92%)
|
2 |
4/102 (3.92%)
|
6 |
1/48 (2.08%)
|
1 |
Septic shock |
2/104 (1.92%)
|
2 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Upper respiratory tract infection |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
1 |
0/48 (0.00%)
|
0 |
Urinary tract infection |
2/104 (1.92%)
|
2 |
1/52 (1.92%)
|
1 |
2/102 (1.96%)
|
2 |
0/48 (0.00%)
|
0 |
Urosepsis |
1/104 (0.96%)
|
1 |
1/52 (1.92%)
|
1 |
1/102 (0.98%)
|
1 |
0/48 (0.00%)
|
0 |
Injury, poisoning and procedural complications |
|
|
|
|
Infusion related reaction |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Post procedural haemorrhage |
0/104 (0.00%)
|
0 |
1/52 (1.92%)
|
1 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Procedural haemorrhage |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Investigations |
|
|
|
|
Alanine aminotransferase increased |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
1 |
0/48 (0.00%)
|
0 |
Blood bilirubin increased |
0/104 (0.00%)
|
0 |
1/52 (1.92%)
|
1 |
1/102 (0.98%)
|
1 |
0/48 (0.00%)
|
0 |
Blood creatinine increased |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
C-reactive protein increased |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
1 |
0/48 (0.00%)
|
0 |
Metabolism and nutrition disorders |
|
|
|
|
Decreased appetite |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Dehydration |
2/104 (1.92%)
|
2 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
1 |
1/48 (2.08%)
|
1 |
Hypercalcaemia |
0/104 (0.00%)
|
0 |
1/52 (1.92%)
|
1 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Hyperkalaemia |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
1/48 (2.08%)
|
1 |
Hypoglycaemia |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Hypokalaemia |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
1 |
0/48 (0.00%)
|
0 |
Hypomagnesaemia |
0/104 (0.00%)
|
0 |
1/52 (1.92%)
|
1 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Hyponatraemia |
1/104 (0.96%)
|
1 |
1/52 (1.92%)
|
1 |
2/102 (1.96%)
|
2 |
1/48 (2.08%)
|
1 |
Hypoproteinaemia |
0/104 (0.00%)
|
0 |
1/52 (1.92%)
|
1 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Musculoskeletal and connective tissue disorders |
|
|
|
|
Arthritis |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Back pain |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Bursitis |
0/104 (0.00%)
|
0 |
1/52 (1.92%)
|
1 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Musculoskeletal pain |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
1 |
0/48 (0.00%)
|
0 |
Neck pain |
0/104 (0.00%)
|
0 |
1/52 (1.92%)
|
1 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Pain in extremity |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
|
|
|
Tumour associated fever |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
1/48 (2.08%)
|
1 |
Nervous system disorders |
|
|
|
|
Cerebral ischaemia |
0/104 (0.00%)
|
0 |
1/52 (1.92%)
|
1 |
2/102 (1.96%)
|
2 |
0/48 (0.00%)
|
0 |
Depressed level of consciousness |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
1 |
0/48 (0.00%)
|
0 |
Haemorrhage intracranial |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Hemiparesis |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
1 |
0/48 (0.00%)
|
0 |
Ischaemic stroke |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
1/48 (2.08%)
|
1 |
Posterior reversible encephalopathy syndrome |
0/104 (0.00%)
|
0 |
1/52 (1.92%)
|
1 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Seizure |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Spinal cord compression |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Transient ischaemic attack |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
1/48 (2.08%)
|
1 |
Product Issues |
|
|
|
|
Device occlusion |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
1/48 (2.08%)
|
1 |
Stent malfunction |
0/104 (0.00%)
|
0 |
1/52 (1.92%)
|
1 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Psychiatric disorders |
|
|
|
|
Confusional state |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
1/48 (2.08%)
|
1 |
Delirium |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
1/48 (2.08%)
|
1 |
Renal and urinary disorders |
|
|
|
|
Acute kidney injury |
2/104 (1.92%)
|
2 |
0/52 (0.00%)
|
0 |
3/102 (2.94%)
|
3 |
2/48 (4.17%)
|
2 |
Reproductive system and breast disorders |
|
|
|
|
Benign prostatic hyperplasia |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
1 |
0/48 (0.00%)
|
0 |
Respiratory, thoracic and mediastinal disorders |
|
|
|
|
Acute respiratory distress syndrome |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
1/48 (2.08%)
|
1 |
Chronic obstructive pulmonary disease |
0/104 (0.00%)
|
0 |
1/52 (1.92%)
|
1 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Dyspnoea |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
2/102 (1.96%)
|
2 |
1/48 (2.08%)
|
1 |
Dyspnoea exertional |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
1 |
0/48 (0.00%)
|
0 |
Hypoxia |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Pneumothorax |
0/104 (0.00%)
|
0 |
1/52 (1.92%)
|
1 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Pulmonary embolism |
3/104 (2.88%)
|
3 |
0/52 (0.00%)
|
0 |
5/102 (4.90%)
|
5 |
1/48 (2.08%)
|
1 |
Pulmonary fibrosis |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Skin and subcutaneous tissue disorders |
|
|
|
|
Dermal cyst |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
1/48 (2.08%)
|
1 |
Rash |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
1 |
0/48 (0.00%)
|
0 |
Rash generalised |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
1 |
0/48 (0.00%)
|
0 |
Vascular disorders |
|
|
|
|
Deep vein thrombosis |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
1 |
0/48 (0.00%)
|
0 |
Embolism venous |
1/104 (0.96%)
|
1 |
1/52 (1.92%)
|
1 |
1/102 (0.98%)
|
1 |
0/48 (0.00%)
|
0 |
Peripheral arterial occlusive disease |
0/104 (0.00%)
|
0 |
1/52 (1.92%)
|
1 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Peripheral embolism |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
1 |
0/48 (0.00%)
|
0 |
Venous thrombosis |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
2/102 (1.96%)
|
2 |
0/48 (0.00%)
|
0 |
Term from vocabulary, MedDRA 22.0
Indicates events were collected by systematic assessment
|
|
Frequency Threshold for Reporting Other Adverse Events
|
0%
|
|
8 mg/kg Ramucirumab + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine
|
Placebo IV + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine
|
80 mg Merestinib + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine
|
Placebo Oral + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine
|
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Total |
102/104 (98.08%)
|
|
49/52 (94.23%)
|
|
100/102 (98.04%)
|
|
48/48 (100.00%)
|
|
Blood and lymphatic system disorders |
|
|
|
|
Anemia |
52/104 (50.00%)
|
94 |
22/52 (42.31%)
|
39 |
40/102 (39.22%)
|
80 |
24/48 (50.00%)
|
33 |
Coagulopathy |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Febrile neutropenia |
0/104 (0.00%)
|
0 |
1/52 (1.92%)
|
1 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Haemolytic uraemic syndrome |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
1 |
0/48 (0.00%)
|
0 |
Iron deficiency anaemia |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Leukocytosis |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Leukopenia |
20/104 (19.23%)
|
45 |
9/52 (17.31%)
|
23 |
20/102 (19.61%)
|
46 |
4/48 (8.33%)
|
15 |
Lymphopenia |
3/104 (2.88%)
|
4 |
2/52 (3.85%)
|
3 |
2/102 (1.96%)
|
3 |
2/48 (4.17%)
|
5 |
Neutropenia |
63/104 (60.58%)
|
160 |
24/52 (46.15%)
|
63 |
52/102 (50.98%)
|
122 |
19/48 (39.58%)
|
60 |
Spleen disorder |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Thrombocytopenia |
56/104 (53.85%)
|
120 |
15/52 (28.85%)
|
31 |
42/102 (41.18%)
|
80 |
15/48 (31.25%)
|
33 |
Thrombocytopenic purpura |
0/104 (0.00%)
|
0 |
1/52 (1.92%)
|
1 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Thrombocytosis |
0/104 (0.00%)
|
0 |
1/52 (1.92%)
|
1 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Cardiac disorders |
|
|
|
|
Angina pectoris |
0/104 (0.00%)
|
0 |
1/52 (1.92%)
|
1 |
1/102 (0.98%)
|
1 |
0/48 (0.00%)
|
0 |
Atrial fibrillation |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Atrial flutter |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
1 |
0/48 (0.00%)
|
0 |
Bradycardia |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
1 |
0/48 (0.00%)
|
0 |
Cardiac failure |
0/104 (0.00%)
|
0 |
1/52 (1.92%)
|
1 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Cardiac failure congestive |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Coronary artery disease |
0/104 (0.00%)
|
0 |
1/52 (1.92%)
|
1 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Palpitations |
2/104 (1.92%)
|
2 |
1/52 (1.92%)
|
1 |
1/102 (0.98%)
|
1 |
1/48 (2.08%)
|
1 |
Sinus bradycardia |
0/104 (0.00%)
|
0 |
1/52 (1.92%)
|
1 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Sinus tachycardia |
3/104 (2.88%)
|
4 |
1/52 (1.92%)
|
1 |
1/102 (0.98%)
|
1 |
0/48 (0.00%)
|
0 |
Tachycardia |
2/104 (1.92%)
|
2 |
2/52 (3.85%)
|
2 |
2/102 (1.96%)
|
2 |
1/48 (2.08%)
|
1 |
Ventricular arrhythmia |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
1/48 (2.08%)
|
1 |
Congenital, familial and genetic disorders |
|
|
|
|
Atrial septal defect |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Hydrocele |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Pyloric stenosis |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
1/48 (2.08%)
|
1 |
Ear and labyrinth disorders |
|
|
|
|
Deafness |
2/104 (1.92%)
|
2 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Ear pain |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
1 |
0/48 (0.00%)
|
0 |
Hypoacusis |
1/104 (0.96%)
|
1 |
1/52 (1.92%)
|
1 |
1/102 (0.98%)
|
1 |
2/48 (4.17%)
|
2 |
Presbyacusis |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Tinnitus |
5/104 (4.81%)
|
5 |
2/52 (3.85%)
|
2 |
2/102 (1.96%)
|
2 |
1/48 (2.08%)
|
1 |
Vertigo |
2/104 (1.92%)
|
2 |
1/52 (1.92%)
|
1 |
2/102 (1.96%)
|
2 |
3/48 (6.25%)
|
3 |
Endocrine disorders |
|
|
|
|
Cushingoid |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Endocrine disorder |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
1 |
0/48 (0.00%)
|
0 |
Hyperparathyroidism |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Hyperthyroidism |
0/104 (0.00%)
|
0 |
1/52 (1.92%)
|
3 |
0/102 (0.00%)
|
0 |
1/48 (2.08%)
|
1 |
Hypothyroidism |
2/104 (1.92%)
|
3 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Inappropriate antidiuretic hormone secretion |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Eye disorders |
|
|
|
|
Conjunctival haemorrhage |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
1/48 (2.08%)
|
1 |
Diplopia |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Dry eye |
1/104 (0.96%)
|
1 |
1/52 (1.92%)
|
1 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Eye irritation |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Eye pruritus |
0/104 (0.00%)
|
0 |
1/52 (1.92%)
|
2 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Eyelid irritation |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
1/48 (2.08%)
|
1 |
Eyelid oedema |
3/104 (2.88%)
|
3 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
1 |
0/48 (0.00%)
|
0 |
Lacrimation increased |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
1 |
0/48 (0.00%)
|
0 |
Ocular hyperaemia |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Optic neuropathy |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
1 |
0/48 (0.00%)
|
0 |
Periorbital oedema |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
1 |
0/48 (0.00%)
|
0 |
Vision blurred |
4/104 (3.85%)
|
7 |
0/52 (0.00%)
|
0 |
3/102 (2.94%)
|
5 |
0/48 (0.00%)
|
0 |
Visual acuity reduced |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
1 |
0/48 (0.00%)
|
0 |
Visual impairment |
0/104 (0.00%)
|
0 |
1/52 (1.92%)
|
2 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Gastrointestinal disorders |
|
|
|
|
Abdominal discomfort |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
1 |
1/48 (2.08%)
|
2 |
Abdominal distension |
10/104 (9.62%)
|
13 |
2/52 (3.85%)
|
2 |
14/102 (13.73%)
|
15 |
2/48 (4.17%)
|
2 |
Abdominal pain |
39/104 (37.50%)
|
54 |
13/52 (25.00%)
|
27 |
33/102 (32.35%)
|
47 |
15/48 (31.25%)
|
26 |
Abdominal rigidity |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
1 |
0/48 (0.00%)
|
0 |
Aerophagia |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
3 |
0/48 (0.00%)
|
0 |
Anal fissure |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
1 |
0/48 (0.00%)
|
0 |
Ascites |
13/104 (12.50%)
|
13 |
2/52 (3.85%)
|
2 |
10/102 (9.80%)
|
11 |
1/48 (2.08%)
|
1 |
Cheilitis |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
1 |
0/48 (0.00%)
|
0 |
Constipation |
33/104 (31.73%)
|
49 |
14/52 (26.92%)
|
23 |
36/102 (35.29%)
|
59 |
13/48 (27.08%)
|
16 |
Defaecation urgency |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Dental caries |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
1 |
0/48 (0.00%)
|
0 |
Diarrhoea |
34/104 (32.69%)
|
50 |
9/52 (17.31%)
|
10 |
29/102 (28.43%)
|
36 |
7/48 (14.58%)
|
13 |
Dry mouth |
5/104 (4.81%)
|
11 |
1/52 (1.92%)
|
1 |
2/102 (1.96%)
|
2 |
1/48 (2.08%)
|
1 |
Dyspepsia |
5/104 (4.81%)
|
8 |
2/52 (3.85%)
|
6 |
4/102 (3.92%)
|
5 |
4/48 (8.33%)
|
6 |
Dysphagia |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
4/102 (3.92%)
|
4 |
0/48 (0.00%)
|
0 |
Epigastric discomfort |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
1 |
0/48 (0.00%)
|
0 |
Faeces discoloured |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Flatulence |
3/104 (2.88%)
|
3 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
1 |
0/48 (0.00%)
|
0 |
Food poisoning |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Gastric haemorrhage |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Gastric ulcer |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Gastritis |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
3/102 (2.94%)
|
3 |
1/48 (2.08%)
|
1 |
Gastritis erosive |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Gastroduodenal haemorrhage |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
1 |
0/48 (0.00%)
|
0 |
Gastrooesophageal reflux disease |
2/104 (1.92%)
|
2 |
0/52 (0.00%)
|
0 |
4/102 (3.92%)
|
5 |
1/48 (2.08%)
|
1 |
Gingival bleeding |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
1/48 (2.08%)
|
1 |
Gingival pain |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Haematochezia |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
2/48 (4.17%)
|
2 |
Haemorrhoidal haemorrhage |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Haemorrhoids |
4/104 (3.85%)
|
4 |
1/52 (1.92%)
|
1 |
4/102 (3.92%)
|
4 |
2/48 (4.17%)
|
2 |
Ileus |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
2 |
0/48 (0.00%)
|
0 |
Ileus paralytic |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
1 |
0/48 (0.00%)
|
0 |
Impaired gastric emptying |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Inguinal hernia |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
2 |
0/48 (0.00%)
|
0 |
Intestinal obstruction |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
1 |
0/48 (0.00%)
|
0 |
Intra-abdominal haemorrhage |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Large intestinal haemorrhage |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
1 |
0/48 (0.00%)
|
0 |
Melaena |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
1 |
0/48 (0.00%)
|
0 |
Mouth ulceration |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Nausea |
52/104 (50.00%)
|
92 |
21/52 (40.38%)
|
39 |
58/102 (56.86%)
|
97 |
15/48 (31.25%)
|
24 |
Obstruction gastric |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
2/102 (1.96%)
|
2 |
0/48 (0.00%)
|
0 |
Odynophagia |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
1 |
0/48 (0.00%)
|
0 |
Oesophageal varices haemorrhage |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
2/102 (1.96%)
|
3 |
0/48 (0.00%)
|
0 |
Oral dysaesthesia |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Oral pain |
1/104 (0.96%)
|
1 |
1/52 (1.92%)
|
1 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Pancreatic failure |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
1 |
0/48 (0.00%)
|
0 |
Pancreatitis |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Periodontal disease |
2/104 (1.92%)
|
2 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Proctalgia |
0/104 (0.00%)
|
0 |
1/52 (1.92%)
|
1 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Rectal haemorrhage |
1/104 (0.96%)
|
2 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
1 |
0/48 (0.00%)
|
0 |
Reflux gastritis |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Regurgitation |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
1/48 (2.08%)
|
3 |
Salivary hypersecretion |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
1 |
0/48 (0.00%)
|
0 |
Stomatitis |
11/104 (10.58%)
|
15 |
5/52 (9.62%)
|
7 |
4/102 (3.92%)
|
6 |
2/48 (4.17%)
|
2 |
Toothache |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
2/102 (1.96%)
|
2 |
0/48 (0.00%)
|
0 |
Upper gastrointestinal haemorrhage |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
1 |
0/48 (0.00%)
|
0 |
Vomiting |
34/104 (32.69%)
|
130 |
12/52 (23.08%)
|
18 |
34/102 (33.33%)
|
93 |
12/48 (25.00%)
|
26 |
General disorders |
|
|
|
|
Catheter site pain |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
1 |
0/48 (0.00%)
|
0 |
Chest discomfort |
2/104 (1.92%)
|
2 |
1/52 (1.92%)
|
1 |
0/102 (0.00%)
|
0 |
1/48 (2.08%)
|
1 |
Chest pain |
1/104 (0.96%)
|
1 |
1/52 (1.92%)
|
1 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Chills |
8/104 (7.69%)
|
18 |
1/52 (1.92%)
|
1 |
5/102 (4.90%)
|
8 |
2/48 (4.17%)
|
2 |
Device related thrombosis |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
1 |
0/48 (0.00%)
|
0 |
Early satiety |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
1 |
1/48 (2.08%)
|
1 |
Face oedema |
5/104 (4.81%)
|
7 |
1/52 (1.92%)
|
1 |
7/102 (6.86%)
|
10 |
2/48 (4.17%)
|
2 |
Fatigue |
61/104 (58.65%)
|
94 |
17/52 (32.69%)
|
22 |
53/102 (51.96%)
|
90 |
22/48 (45.83%)
|
34 |
Gait disturbance |
1/104 (0.96%)
|
2 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
1 |
0/48 (0.00%)
|
0 |
General physical health deterioration |
0/104 (0.00%)
|
0 |
1/52 (1.92%)
|
1 |
0/102 (0.00%)
|
0 |
1/48 (2.08%)
|
1 |
Generalised oedema |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
1 |
0/48 (0.00%)
|
0 |
Impaired healing |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Influenza like illness |
2/104 (1.92%)
|
3 |
2/52 (3.85%)
|
2 |
3/102 (2.94%)
|
4 |
0/48 (0.00%)
|
0 |
Infusion site extravasation |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
1 |
1/48 (2.08%)
|
1 |
Infusion site thrombosis |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Injection site haemorrhage |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
1/48 (2.08%)
|
1 |
Injection site rash |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
1/48 (2.08%)
|
1 |
Injection site reaction |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
1 |
0/48 (0.00%)
|
0 |
Localised oedema |
1/104 (0.96%)
|
1 |
1/52 (1.92%)
|
1 |
3/102 (2.94%)
|
3 |
0/48 (0.00%)
|
0 |
Malaise |
3/104 (2.88%)
|
3 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
1 |
1/48 (2.08%)
|
1 |
Mucosal inflammation |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
3/102 (2.94%)
|
3 |
2/48 (4.17%)
|
2 |
Non-cardiac chest pain |
1/104 (0.96%)
|
1 |
1/52 (1.92%)
|
1 |
3/102 (2.94%)
|
3 |
1/48 (2.08%)
|
2 |
Oedema |
2/104 (1.92%)
|
2 |
0/52 (0.00%)
|
0 |
4/102 (3.92%)
|
4 |
0/48 (0.00%)
|
0 |
Oedema peripheral |
33/104 (31.73%)
|
46 |
7/52 (13.46%)
|
10 |
18/102 (17.65%)
|
22 |
6/48 (12.50%)
|
9 |
Pain |
5/104 (4.81%)
|
5 |
2/52 (3.85%)
|
2 |
1/102 (0.98%)
|
1 |
3/48 (6.25%)
|
3 |
Peripheral swelling |
2/104 (1.92%)
|
2 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
2 |
1/48 (2.08%)
|
1 |
Pyrexia |
25/104 (24.04%)
|
46 |
6/52 (11.54%)
|
12 |
26/102 (25.49%)
|
52 |
9/48 (18.75%)
|
11 |
Secretion discharge |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
1 |
0/48 (0.00%)
|
0 |
Hepatobiliary disorders |
|
|
|
|
Bile duct obstruction |
0/104 (0.00%)
|
0 |
1/52 (1.92%)
|
1 |
1/102 (0.98%)
|
1 |
1/48 (2.08%)
|
1 |
Bile duct stenosis |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Biliary colic |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
1/48 (2.08%)
|
1 |
Cholangitis |
3/104 (2.88%)
|
6 |
1/52 (1.92%)
|
1 |
3/102 (2.94%)
|
3 |
4/48 (8.33%)
|
4 |
Hepatic failure |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
2/102 (1.96%)
|
2 |
0/48 (0.00%)
|
0 |
Hepatic infarction |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Hepatic pain |
0/104 (0.00%)
|
0 |
1/52 (1.92%)
|
1 |
2/102 (1.96%)
|
3 |
0/48 (0.00%)
|
0 |
Hepatocellular injury |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
1/48 (2.08%)
|
1 |
Hepatomegaly |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Hyperbilirubinaemia |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
1 |
2/48 (4.17%)
|
2 |
Hypertransaminasaemia |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
2/102 (1.96%)
|
2 |
0/48 (0.00%)
|
0 |
Jaundice |
2/104 (1.92%)
|
2 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
1 |
2/48 (4.17%)
|
2 |
Jaundice cholestatic |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
1/48 (2.08%)
|
1 |
Portal vein stenosis |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
1 |
0/48 (0.00%)
|
0 |
Portal vein thrombosis |
2/104 (1.92%)
|
2 |
0/52 (0.00%)
|
0 |
3/102 (2.94%)
|
3 |
0/48 (0.00%)
|
0 |
Immune system disorders |
|
|
|
|
Allergy to arthropod sting |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Contrast media allergy |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
1 |
0/48 (0.00%)
|
0 |
Drug hypersensitivity |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
3/102 (2.94%)
|
3 |
0/48 (0.00%)
|
0 |
Hypersensitivity |
3/104 (2.88%)
|
4 |
1/52 (1.92%)
|
1 |
2/102 (1.96%)
|
2 |
0/48 (0.00%)
|
0 |
Seasonal allergy |
0/104 (0.00%)
|
0 |
1/52 (1.92%)
|
1 |
0/102 (0.00%)
|
0 |
1/48 (2.08%)
|
1 |
Infections and infestations |
|
|
|
|
Abdominal infection |
1/104 (0.96%)
|
1 |
1/52 (1.92%)
|
1 |
1/102 (0.98%)
|
1 |
0/48 (0.00%)
|
0 |
Acute sinusitis |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Bacteraemia |
2/104 (1.92%)
|
2 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Biliary sepsis |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Biliary tract infection |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
2 |
0/48 (0.00%)
|
0 |
Bronchitis |
0/104 (0.00%)
|
0 |
2/52 (3.85%)
|
3 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Candida infection |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Cellulitis |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Cholecystitis infective |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
1 |
1/48 (2.08%)
|
1 |
Clostridium difficile colitis |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
1 |
1/48 (2.08%)
|
1 |
Cystitis |
2/104 (1.92%)
|
2 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
1/48 (2.08%)
|
1 |
Device related infection |
4/104 (3.85%)
|
4 |
0/52 (0.00%)
|
0 |
2/102 (1.96%)
|
2 |
0/48 (0.00%)
|
0 |
Diverticulitis |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Ear infection |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Enterococcal infection |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Escherichia infection |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Fungaemia |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Fungal infection |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
1/48 (2.08%)
|
1 |
Gastroenteritis viral |
0/104 (0.00%)
|
0 |
0/52 (0.00%)
|
0 |
1/102 (0.98%)
|
1 |
0/48 (0.00%)
|
0 |
Gingivitis |
4/104 (3.85%)
|
4 |
1/52 (1.92%)
|
2 |
3/102 (2.94%)
|
3 |
1/48 (2.08%)
|
1 |
Helicobacter infection |
1/104 (0.96%)
|
1 |
0/52 (0.00%)
|
0 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Hepatic infection |
0/104 (0.00%)
|
0 |
1/52 (1.92%)
|
1 |
1/102 (0.98%)
|
1 |
0/48 (0.00%)
|
0 |
Herpes zoster |
0/104 (0.00%)
|
0 |
2/52 (3.85%)
|
2 |
0/102 (0.00%)
|
0 |
0/48 (0.00%)
|
0 |
Hordeolum |
1/104 (0.96%)
|
1 |
|