Time Frame |
[Not Specified]
|
Adverse Event Reporting Description |
Deaths due to progressive disease are not considered adverse events and reported in the participant flow. All randomized participants who received at least 1 dose of study drug during the specified treatment phase.
|
|
Arm/Group Title
|
Pem/Carbo/Bev
|
Pac/Carbo/Bev
|
Arm/Group Description |
Induction:
...
|
Induction:
...
|
Arm/Group Description |
Induction:
Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days
Maintenance:
Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.
|
Induction:
Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m ²) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days
Maintenance:
Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.
|
|
|
Pem/Carbo/Bev
|
Pac/Carbo/Bev
|
|
Affected / at Risk (%) |
|
Affected / at Risk (%) |
|
Total |
--/--
|
|
--/--
|
|
|
|
Pem/Carbo/Bev
|
Pac/Carbo/Bev
|
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Total |
188/442 (42.53%)
|
|
181/443 (40.86%)
|
|
Blood and lymphatic system disorders |
|
|
Anaemia |
18/442 (4.07%)
|
50 |
5/443 (1.13%)
|
10 |
Febrile neutropenia |
6/442 (1.36%)
|
7 |
13/443 (2.93%)
|
13 |
Haemorrhagic anaemia |
1/442 (0.23%)
|
1 |
0/443 (0.00%)
|
0 |
Leukocytosis |
1/442 (0.23%)
|
2 |
0/443 (0.00%)
|
0 |
Leukopenia |
3/442 (0.68%)
|
7 |
0/443 (0.00%)
|
0 |
Microangiopathic haemolytic anaemia |
1/442 (0.23%)
|
2 |
0/443 (0.00%)
|
0 |
Neutropenia |
10/442 (2.26%)
|
15 |
9/443 (2.03%)
|
9 |
Pancytopenia |
3/442 (0.68%)
|
5 |
3/443 (0.68%)
|
3 |
Thrombocytopenia |
12/442 (2.71%)
|
20 |
3/443 (0.68%)
|
3 |
Cardiac disorders |
|
|
Acute myocardial infarction |
0/442 (0.00%)
|
0 |
2/443 (0.45%)
|
4 |
Angina pectoris |
1/442 (0.23%)
|
1 |
3/443 (0.68%)
|
3 |
Atrial fibrillation |
1/442 (0.23%)
|
4 |
3/443 (0.68%)
|
3 |
Atrial flutter |
1/442 (0.23%)
|
1 |
0/443 (0.00%)
|
0 |
Cardiac arrest |
3/442 (0.68%)
|
3 |
2/443 (0.45%)
|
3 |
Cardiac failure congestive |
3/442 (0.68%)
|
3 |
3/443 (0.68%)
|
3 |
Cardio-respiratory arrest |
0/442 (0.00%)
|
0 |
3/443 (0.68%)
|
3 |
Cardiomegaly |
1/442 (0.23%)
|
1 |
0/443 (0.00%)
|
0 |
Cardiomyopathy |
1/442 (0.23%)
|
4 |
1/443 (0.23%)
|
2 |
Myocardial infarction |
6/442 (1.36%)
|
6 |
2/443 (0.45%)
|
2 |
Myocardial ischaemia |
0/442 (0.00%)
|
0 |
1/443 (0.23%)
|
1 |
Palpitations |
1/442 (0.23%)
|
1 |
0/443 (0.00%)
|
0 |
Pericardial effusion |
1/442 (0.23%)
|
1 |
2/443 (0.45%)
|
3 |
Pericarditis |
1/442 (0.23%)
|
1 |
0/443 (0.00%)
|
0 |
Sinus bradycardia |
0/442 (0.00%)
|
0 |
1/443 (0.23%)
|
1 |
Supraventricular tachycardia |
4/442 (0.90%)
|
4 |
1/443 (0.23%)
|
2 |
Ear and labyrinth disorders |
|
|
Vertigo |
0/442 (0.00%)
|
0 |
1/443 (0.23%)
|
1 |
Endocrine disorders |
|
|
Addison's disease |
0/442 (0.00%)
|
0 |
1/443 (0.23%)
|
8 |
Goitre |
1/442 (0.23%)
|
1 |
0/443 (0.00%)
|
0 |
Hypercalcaemia of malignancy |
1/442 (0.23%)
|
1 |
0/443 (0.00%)
|
0 |
Inappropriate antidiuretic hormone secretion |
2/442 (0.45%)
|
3 |
1/443 (0.23%)
|
1 |
Eye disorders |
|
|
Diplopia |
0/442 (0.00%)
|
0 |
1/443 (0.23%)
|
1 |
Gastrointestinal disorders |
|
|
Abdominal pain |
3/442 (0.68%)
|
5 |
6/443 (1.35%)
|
7 |
Abdominal pain upper |
0/442 (0.00%)
|
0 |
1/443 (0.23%)
|
1 |
Anal haemorrhage |
1/442 (0.23%)
|
1 |
0/443 (0.00%)
|
0 |
Constipation |
5/442 (1.13%)
|
6 |
4/443 (0.90%)
|
4 |
Diarrhoea |
4/442 (0.90%)
|
9 |
7/443 (1.58%)
|
9 |
Diverticular perforation |
1/442 (0.23%)
|
1 |
0/443 (0.00%)
|
0 |
Duodenal ulcer |
0/442 (0.00%)
|
0 |
1/443 (0.23%)
|
6 |
Duodenal ulcer haemorrhage |
2/442 (0.45%)
|
2 |
0/443 (0.00%)
|
0 |
Duodenitis |
0/442 (0.00%)
|
0 |
1/443 (0.23%)
|
2 |
Dysphagia |
1/442 (0.23%)
|
4 |
0/443 (0.00%)
|
0 |
Faecaloma |
0/442 (0.00%)
|
0 |
1/443 (0.23%)
|
1 |
Gastric ulcer |
0/442 (0.00%)
|
0 |
1/443 (0.23%)
|
2 |
Gastritis |
1/442 (0.23%)
|
1 |
1/443 (0.23%)
|
1 |
Gastrointestinal haemorrhage |
3/442 (0.68%)
|
4 |
5/443 (1.13%)
|
5 |
Gastrointestinal perforation |
1/442 (0.23%)
|
1 |
0/443 (0.00%)
|
0 |
Haematemesis |
1/442 (0.23%)
|
1 |
1/443 (0.23%)
|
1 |
Haemorrhoids |
0/442 (0.00%)
|
0 |
1/443 (0.23%)
|
1 |
Ileus |
1/442 (0.23%)
|
1 |
2/443 (0.45%)
|
4 |
Ileus paralytic |
1/442 (0.23%)
|
1 |
0/443 (0.00%)
|
0 |
Inguinal hernia |
0/442 (0.00%)
|
0 |
1/443 (0.23%)
|
1 |
Intestinal perforation |
2/442 (0.45%)
|
7 |
1/443 (0.23%)
|
1 |
Large intestine perforation |
1/442 (0.23%)
|
1 |
1/443 (0.23%)
|
1 |
Lower gastrointestinal haemorrhage |
0/442 (0.00%)
|
0 |
1/443 (0.23%)
|
1 |
Nausea |
9/442 (2.04%)
|
17 |
11/443 (2.48%)
|
21 |
Oesophageal obstruction |
0/442 (0.00%)
|
0 |
1/443 (0.23%)
|
2 |
Oesophagitis |
1/442 (0.23%)
|
2 |
0/443 (0.00%)
|
0 |
Pancreatitis |
0/442 (0.00%)
|
0 |
2/443 (0.45%)
|
2 |
Peptic ulcer |
1/442 (0.23%)
|
2 |
0/443 (0.00%)
|
0 |
Proctalgia |
0/442 (0.00%)
|
0 |
1/443 (0.23%)
|
1 |
Rectal haemorrhage |
2/442 (0.45%)
|
4 |
1/443 (0.23%)
|
1 |
Small intestinal obstruction |
2/442 (0.45%)
|
3 |
1/443 (0.23%)
|
1 |
Small intestinal perforation |
0/442 (0.00%)
|
0 |
1/443 (0.23%)
|
1 |
Stomatitis |
0/442 (0.00%)
|
0 |
2/443 (0.45%)
|
3 |
Upper gastrointestinal haemorrhage |
3/442 (0.68%)
|
6 |
1/443 (0.23%)
|
1 |
Vomiting |
13/442 (2.94%)
|
20 |
11/443 (2.48%)
|
12 |
General disorders |
|
|
Asthenia |
2/442 (0.45%)
|
4 |
9/443 (2.03%)
|
15 |
Chest pain |
1/442 (0.23%)
|
1 |
2/443 (0.45%)
|
2 |
Death |
1/442 (0.23%)
|
1 |
2/443 (0.45%)
|
2 |
Device dislocation |
1/442 (0.23%)
|
1 |
0/443 (0.00%)
|
0 |
Device malfunction |
1/442 (0.23%)
|
2 |
0/443 (0.00%)
|
0 |
Fatigue |
1/442 (0.23%)
|
4 |
3/443 (0.68%)
|
5 |
Hypothermia |
1/442 (0.23%)
|
1 |
0/443 (0.00%)
|
0 |
Impaired healing |
0/442 (0.00%)
|
0 |
1/443 (0.23%)
|
7 |
Malaise |
0/442 (0.00%)
|
0 |
1/443 (0.23%)
|
1 |
Mucosal inflammation |
2/442 (0.45%)
|
3 |
0/443 (0.00%)
|
0 |
Multi-organ failure |
0/442 (0.00%)
|
0 |
1/443 (0.23%)
|
1 |
Non-cardiac chest pain |
5/442 (1.13%)
|
6 |
1/443 (0.23%)
|
1 |
Pain |
0/442 (0.00%)
|
0 |
1/443 (0.23%)
|
1 |
Pyrexia |
3/442 (0.68%)
|
4 |
4/443 (0.90%)
|
5 |
Hepatobiliary disorders |
|
|
Acute hepatic failure |
0/442 (0.00%)
|
0 |
1/443 (0.23%)
|
1 |
Bile duct obstruction |
1/442 (0.23%)
|
1 |
1/443 (0.23%)
|
1 |
Cholecystitis |
0/442 (0.00%)
|
0 |
2/443 (0.45%)
|
3 |
Cholelithiasis |
0/442 (0.00%)
|
0 |
3/443 (0.68%)
|
3 |
Hepatic haemorrhage |
1/442 (0.23%)
|
1 |
0/443 (0.00%)
|
0 |
Hyperbilirubinaemia |
1/442 (0.23%)
|
1 |
0/443 (0.00%)
|
0 |
Immune system disorders |
|
|
Drug hypersensitivity |
0/442 (0.00%)
|
0 |
1/443 (0.23%)
|
1 |
Hypersensitivity |
1/442 (0.23%)
|
2 |
0/443 (0.00%)
|
0 |
Infections and infestations |
|
|
Appendicitis perforated |
1/442 (0.23%)
|
1 |
0/443 (0.00%)
|
0 |
Bacteraemia |
1/442 (0.23%)
|
1 |
0/443 (0.00%)
|
0 |
Bronchitis |
1/442 (0.23%)
|
1 |
2/443 (0.45%)
|
3 |
Cellulitis |
3/442 (0.68%)
|
5 |
3/443 (0.68%)
|
3 |
Clostridial infection |
1/442 (0.23%)
|
1 |
0/443 (0.00%)
|
0 |
Clostridium colitis |
1/442 (0.23%)
|
1 |
0/443 (0.00%)
|
0 |
Clostridium difficile colitis |
1/442 (0.23%)
|
1 |
0/443 (0.00%)
|
0 |
Device related sepsis |
2/442 (0.45%)
|
2 |
0/443 (0.00%)
|
0 |
Diverticulitis |
1/442 (0.23%)
|
1 |
3/443 (0.68%)
|
8 |
Empyema |
1/442 (0.23%)
|
1 |
0/443 (0.00%)
|
0 |
Enterobacter sepsis |
1/442 (0.23%)
|
1 |
0/443 (0.00%)
|
0 |
Gastroenteritis |
1/442 (0.23%)
|
1 |
2/443 (0.45%)
|
2 |
Hepatitis c |
0/442 (0.00%)
|
0 |
1/443 (0.23%)
|
1 |
Infection |
2/442 (0.45%)
|
2 |
0/443 (0.00%)
|
0 |
Infectious peritonitis |
2/442 (0.45%)
|
2 |
0/443 (0.00%)
|
0 |
Liver abscess |
1/442 (0.23%)
|
1 |
0/443 (0.00%)
|
0 |
Lobar pneumonia |
2/442 (0.45%)
|
2 |
1/443 (0.23%)
|
1 |
Lung infection pseudomonal |
1/442 (0.23%)
|
7 |
0/443 (0.00%)
|
0 |
Meningitis herpes |
0/442 (0.00%)
|
0 |
1/443 (0.23%)
|
2 |
Osteomyelitis |
1/442 (0.23%)
|
1 |
0/443 (0.00%)
|
0 |
Perirectal abscess |
1/442 (0.23%)
|
10 |
1/443 (0.23%)
|
2 |
Pneumonia |
28/442 (6.33%)
|
39 |
27/443 (6.09%)
|
42 |
Pneumonia pneumococcal |
1/442 (0.23%)
|
1 |
0/443 (0.00%)
|
0 |
Pneumonia streptococcal |
0/442 (0.00%)
|
0 |
1/443 (0.23%)
|
17 |
Pseudomonal sepsis |
1/442 (0.23%)
|
1 |
1/443 (0.23%)
|
2 |
Respiratory tract infection |
1/442 (0.23%)
|
1 |
0/443 (0.00%)
|
0 |
Retroperitoneal abscess |
1/442 (0.23%)
|
1 |
0/443 (0.00%)
|
0 |
Sepsis |
6/442 (1.36%)
|
7 |
2/443 (0.45%)
|
2 |
Sepsis syndrome |
1/442 (0.23%)
|
1 |
0/443 (0.00%)
|
0 |
Septic shock |
2/442 (0.45%)
|
3 |
0/443 (0.00%)
|
0 |
Staphylococcal bacteraemia |
1/442 (0.23%)
|
1 |
0/443 (0.00%)
|
0 |
Staphylococcal infection |
0/442 (0.00%)
|
0 |
1/443 (0.23%)
|
1 |
Staphylococcal sepsis |
0/442 (0.00%)
|
0 |
1/443 (0.23%)
|
1 |
Streptococcal bacteraemia |
1/442 (0.23%)
|
2 |
0/443 (0.00%)
|
0 |
Tooth abscess |
1/442 (0.23%)
|
1 |
0/443 (0.00%)
|
0 |
Upper respiratory tract infection |
0/442 (0.00%)
|
0 |
1/443 (0.23%)
|
1 |
Urinary tract infection |
0/442 (0.00%)
|
0 |
3/443 (0.68%)
|
4 |
Urinary tract infection bacterial |
1/442 (0.23%)
|
1 |
1/443 (0.23%)
|
1 |
Viral upper respiratory tract infection |
1/442 (0.23%)
|
1 |
0/443 (0.00%)
|
0 |
Wound abscess |
0/442 (0.00%)
|
0 |
1/443 (0.23%)
|
1 |
Injury, poisoning and procedural complications |
|
|
Accidental overdose |
0/442 (0.00%)
|
0 |
1/443 (0.23%)
|
1 |
Compression fracture |
1/442 (0.23%)
|
1 |
0/443 (0.00%)
|
0 |
Fall |
1/442 (0.23%)
|
1 |
2/443 (0.45%)
|
3 |
Femur fracture |
2/442 (0.45%)
|
2 |
0/443 (0.00%)
|
0 |
Head injury |
1/442 (0.23%)
|
1 |
0/443 (0.00%)
|
0 |
Hip fracture |
1/442 (0.23%)
|
1 |
1/443 (0.23%)
|
2 |
Humerus fracture |
0/442 (0.00%)
|
0 |
1/443 (0.23%)
|
1 |
Lower limb fracture |
0/442 (0.00%)
|
0 |
1/443 (0.23%)
|
1 |
Overdose |
0/442 (0.00%)
|
0 |
1/443 (0.23%)
|
1 |
Radiation oesophagitis |
0/442 (0.00%)
|
0 |
1/443 (0.23%)
|
1 |
Rib fracture |
0/442 (0.00%)
|
0 |
1/443 (0.23%)
|
14 |
Road traffic accident |
0/442 (0.00%)
|
0 |
1/443 (0.23%)
|
1 |
Spinal compression fracture |
2/442 (0.45%)
|
15 |
1/443 (0.23%)
|
2 |
Wrong drug administered |
0/442 (0.00%)
|
0 |
1/443 (0.23%)
|
1 |
Investigations |
|
|
Alanine aminotransferase increased |
1/442 (0.23%)
|
1 |
0/443 (0.00%)
|
0 |
Aspartate aminotransferase increased |
1/442 (0.23%)
|
1 |
0/443 (0.00%)
|
0 |
Aspiration pleural cavity |
1/442 (0.23%)
|
1 |
0/443 (0.00%)
|
0 |
International normalised ratio increased |
1/442 (0.23%)
|
1 |
0/443 (0.00%)
|
0 |
Platelet count decreased |
1/442 (0.23%)
|
1 |
0/443 (0.00%)
|
0 |
Troponin i increased |
0/442 (0.00%)
|
0 |
1/443 (0.23%)
|
2 |
Metabolism and nutrition disorders |
|
|
Decreased appetite |
1/442 (0.23%)
|
2 |
2/443 (0.45%)
|
3 |
Dehydration |
20/442 (4.52%)
|
27 |
21/443 (4.74%)
|
26 |
Electrolyte imbalance |
0/442 (0.00%)
|
0 |
1/443 (0.23%)
|
1 |
Failure to thrive |
1/442 (0.23%)
|
3 |
0/443 (0.00%)
|
0 |
Hypercalcaemia |
1/442 (0.23%)
|
2 |
0/443 (0.00%)
|
0 |
Hyperglycaemia |
1/442 (0.23%)
|
1 |
0/443 (0.00%)
|
0 |
Hyperkalaemia |
0/442 (0.00%)
|
0 |
1/443 (0.23%)
|
1 |
Hypocalcaemia |
1/442 (0.23%)
|
1 |
0/443 (0.00%)
|
0 |
Hypoglycaemia |
2/442 (0.45%)
|
3 |
1/443 (0.23%)
|
1 |
Hypokalaemia |
5/442 (1.13%)
|
8 |
2/443 (0.45%)
|
2 |
Hypomagnesaemia |
0/442 (0.00%)
|
0 |
1/443 (0.23%)
|
2 |
Hyponatraemia |
3/442 (0.68%)
|
4 |
8/443 (1.81%)
|
9 |
Hypophosphataemia |
1/442 (0.23%)
|
1 |
0/443 (0.00%)
|
0 |
Lactic acidosis |
0/442 (0.00%)
|
0 |
1/443 (0.23%)
|
1 |
Malnutrition |
1/442 (0.23%)
|
2 |
0/443 (0.00%)
|
0 |
Metabolic acidosis |
1/442 (0.23%)
|
1 |
0/443 (0.00%)
|
0 |
Metabolic alkalosis |
0/442 (0.00%)
|
0 |
1/443 (0.23%)
|
1 |
Starvation |
1/442 (0.23%)
|
1 |
0/443 (0.00%)
|
0 |
Tumour lysis syndrome |
0/442 (0.00%)
|
0 |
1/443 (0.23%)
|
1 |
Musculoskeletal and connective tissue disorders |
|
|
Arthralgia |
1/442 (0.23%)
|
2 |
2/443 (0.45%)
|
11 |
Back pain |
2/442 (0.45%)
|
8 |
4/443 (0.90%)
|
9 |
Bone pain |
0/442 (0.00%)
|
0 |
1/443 (0.23%)
|
1 |
Fracture nonunion |
0/442 (0.00%)
|
0 |
1/443 (0.23%)
|
1 |
Groin pain |
0/442 (0.00%)
|
0 |
1/443 (0.23%)
|
2 |
Muscular weakness |
0/442 (0.00%)
|
0 |
1/443 (0.23%)
|
1 |
Musculoskeletal pain |
1/442 (0.23%)
|
1 |
2/443 (0.45%)
|
3 |
Pathological fracture |
1/442 (0.23%)
|
1 |
1/443 (0.23%)
|
1 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
|
Colon cancer |
1/442 (0.23%)
|
1 |
0/443 (0.00%)
|
0 |
Malignant pleural effusion |
2/442 (0.45%)
|
6 |
1/443 (0.23%)
|
1 |
Metastases to central nervous system |
0/442 (0.00%)
|
0 |
1/443 (0.23%)
|
1 |
Metastases to liver |
0/442 (0.00%)
|
0 |
1/443 (0.23%)
|
8 |
Metastases to meninges |
0/442 (0.00%)
|
0 |
1/443 (0.23%)
|
2 |
Metastatic pain |
3/442 (0.68%)
|
5 |
1/443 (0.23%)
|
1 |
Neoplasm malignant |
0/442 (0.00%)
|
0 |
1/443 (0.23%)
|
1 |
Neurilemmoma |
0/442 (0.00%)
|
0 |
1/443 (0.23%)
|
2 |
Pericardial effusion malignant |
0/442 (0.00%)
|
0 |
1/443 (0.23%)
|
1 |
Prostate cancer |
0/442 (0.00%)
|
0 |
1/235 (0.43%)
|
3 |
Tumour pain |
2/442 (0.45%)
|
2 |
0/443 (0.00%)
|
0 |
Nervous system disorders |
|
|
Ataxia |
0/442 (0.00%)
|
0 |
1/443 (0.23%)
|
1 |
Cerebral haemorrhage |
1/442 (0.23%)
|
1 |
0/443 (0.00%)
|
0 |
Cerebral infarction |
1/442 (0.23%)
|
1 |
2/443 (0.45%)
|
3 |
Cerebral ischaemia |
1/442 (0.23%)
|
2 |
2/443 (0.45%)
|
3 |
Cerebrovascular accident |
5/442 (1.13%)
|
9 |
3/443 (0.68%)
|
4 |
Convulsion |
0/442 (0.00%)
|
0 |
2/443 (0.45%)
|
2 |
Dizziness |
1/442 (0.23%)
|
1 |
2/443 (0.45%)
|
2 |
Encephalopathy |
0/442 (0.00%)
|
0 |
1/443 (0.23%)
|
2 |
Grand mal convulsion |
0/442 (0.00%)
|
0 |
1/443 (0.23%)
|
1 |
Haemorrhage intracranial |
0/442 (0.00%)
|
0 |
1/443 (0.23%)
|
1 |
Haemorrhagic stroke |
1/442 (0.23%)
|
1 |
0/443 (0.00%)
|
0 |
Ischaemic cerebral infarction |
1/442 (0.23%)
|
1 |
0/443 (0.00%)
|
0 |
Lethargy |
1/442 (0.23%)
|
1 |
0/443 (0.00%)
|
0 |
Metabolic encephalopathy |
1/442 (0.23%)
|
1 |
0/443 (0.00%)
|
0 |
Nerve compression |
0/442 (0.00%)
|
0 |
1/443 (0.23%)
|
7 |
Neuropathy peripheral |
0/442 (0.00%)
|
0 |
1/443 (0.23%)
|
1 |
Paraesthesia |
0/442 (0.00%)
|
0 |
1/443 (0.23%)
|
3 |
Parkinson's disease |
0/442 (0.00%)
|
0 |
1/443 (0.23%)
|
11 |
Somnolence |
1/442 (0.23%)
|
1 |
0/443 (0.00%)
|
0 |
Status epilepticus |
1/442 (0.23%)
|
1 |
0/443 (0.00%)
|
0 |
Subarachnoid haemorrhage |
2/442 (0.45%)
|
2 |
0/443 (0.00%)
|
0 |
Syncope |
3/442 (0.68%)
|
3 |
1/443 (0.23%)
|
1 |
Transient ischaemic attack |
3/442 (0.68%)
|
3 |
2/443 (0.45%)
|
2 |
Unresponsive to stimuli |
1/442 (0.23%)
|
2 |
0/443 (0.00%)
|
0 |
Psychiatric disorders |
|
|
Anxiety |
0/442 (0.00%)
|
0 |
1/443 (0.23%)
|
1 |
Confusional state |
5/442 (1.13%)
|
5 |
2/443 (0.45%)
|
2 |
Delirium |
0/442 (0.00%)
|
0 |
1/443 (0.23%)
|
2 |
Mental status changes |
4/442 (0.90%)
|
4 |
2/443 (0.45%)
|
3 |
Renal and urinary disorders |
|
|
Nephrotic syndrome |
1/442 (0.23%)
|
3 |
0/443 (0.00%)
|
0 |
Renal failure |
1/442 (0.23%)
|
7 |
0/443 (0.00%)
|
0 |
Renal failure acute |
7/442 (1.58%)
|
10 |
4/443 (0.90%)
|
5 |
Renal tubular necrosis |
1/442 (0.23%)
|
1 |
0/443 (0.00%)
|
0 |
Urinary retention |
1/442 (0.23%)
|
1 |
0/443 (0.00%)
|
0 |
Urinary tract obstruction |
0/442 (0.00%)
|
0 |
1/443 (0.23%)
|
1 |
Respiratory, thoracic and mediastinal disorders |
|
|
Acquired tracheo-oesophageal fistula |
1/442 (0.23%)
|
2 |
0/443 (0.00%)
|
0 |
Acute respiratory distress syndrome |
1/442 (0.23%)
|
1 |
2/443 (0.45%)
|
2 |
Acute respiratory failure |
1/442 (0.23%)
|
3 |
2/443 (0.45%)
|
2 |
Aspiration |
1/442 (0.23%)
|
4 |
0/443 (0.00%)
|
0 |
Bronchial fistula |
0/442 (0.00%)
|
0 |
1/443 (0.23%)
|
1 |
Bronchospasm |
1/442 (0.23%)
|
1 |
0/443 (0.00%)
|
0 |
Chronic obstructive pulmonary disease |
7/442 (1.58%)
|
30 |
2/443 (0.45%)
|
22 |
Dyspnoea |
7/442 (1.58%)
|
14 |
8/443 (1.81%)
|
18 |
Emphysema |
1/442 (0.23%)
|
1 |
0/443 (0.00%)
|
0 |
Epistaxis |
6/442 (1.36%)
|
7 |
2/443 (0.45%)
|
2 |
Haemoptysis |
8/442 (1.81%)
|
11 |
3/443 (0.68%)
|
6 |
Hydropneumothorax |
0/442 (0.00%)
|
0 |
4/443 (0.90%)
|
10 |
Hypoxia |
0/442 (0.00%)
|
0 |
1/443 (0.23%)
|
1 |
Pleural effusion |
3/442 (0.68%)
|
6 |
6/443 (1.35%)
|
9 |
Pleuritic pain |
1/442 (0.23%)
|
1 |
1/443 (0.23%)
|
2 |
Pneumonia aspiration |
1/442 (0.23%)
|
2 |
3/443 (0.68%)
|
3 |
Pneumothorax |
2/442 (0.45%)
|
2 |
2/443 (0.45%)
|
2 |
Pulmonary embolism |
10/442 (2.26%)
|
21 |
9/443 (2.03%)
|
14 |
Pulmonary haemorrhage |
2/442 (0.45%)
|
2 |
1/443 (0.23%)
|
1 |
Pulmonary hypertension |
0/442 (0.00%)
|
0 |
1/443 (0.23%)
|
1 |
Respiratory distress |
0/442 (0.00%)
|
0 |
1/443 (0.23%)
|
1 |
Respiratory failure |
11/442 (2.49%)
|
13 |
4/443 (0.90%)
|
4 |
Skin and subcutaneous tissue disorders |
|
|
Skin disorder |
0/442 (0.00%)
|
0 |
1/443 (0.23%)
|
1 |
Surgical and medical procedures |
|
|
Lung neoplasm surgery |
1/442 (0.23%)
|
2 |
0/443 (0.00%)
|
0 |
Vascular disorders |
|
|
Arterial thrombosis |
0/442 (0.00%)
|
0 |
1/443 (0.23%)
|
1 |
Deep vein thrombosis |
5/442 (1.13%)
|
16 |
14/443 (3.16%)
|
34 |
Haemorrhage |
1/442 (0.23%)
|
1 |
1/443 (0.23%)
|
1 |
Hypertension |
2/442 (0.45%)
|
5 |
1/443 (0.23%)
|
7 |
Hypertensive crisis |
0/442 (0.00%)
|
0 |
1/443 (0.23%)
|
1 |
Hypotension |
3/442 (0.68%)
|
3 |
3/443 (0.68%)
|
5 |
Intra-abdominal haemorrhage |
1/442 (0.23%)
|
1 |
0/443 (0.00%)
|
0 |
Jugular vein thrombosis |
0/442 (0.00%)
|
0 |
1/443 (0.23%)
|
1 |
Orthostatic hypotension |
0/442 (0.00%)
|
0 |
1/443 (0.23%)
|
1 |
Post thrombotic syndrome |
1/442 (0.23%)
|
1 |
0/443 (0.00%)
|
0 |
Shock |
1/442 (0.23%)
|
1 |
0/443 (0.00%)
|
0 |
Superior vena cava syndrome |
1/442 (0.23%)
|
5 |
0/443 (0.00%)
|
0 |
Indicates events were collected by systematic assessment
Term from vocabulary, MedDRA 14.1
|
|
Frequency Threshold for Reporting Other Adverse Events
|
5%
|
|
Pem/Carbo/Bev
|
Pac/Carbo/Bev
|
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Total |
430/442 (97.29%)
|
|
433/443 (97.74%)
|
|
Blood and lymphatic system disorders |
|
|
Anaemia |
177/442 (40.05%)
|
1367 |
136/443 (30.70%)
|
793 |
Leukopenia |
73/442 (16.52%)
|
387 |
76/443 (17.16%)
|
362 |
Neutropenia |
170/442 (38.46%)
|
733 |
219/443 (49.44%)
|
790 |
Thrombocytopenia |
159/442 (35.97%)
|
829 |
105/443 (23.70%)
|
452 |
Eye disorders |
|
|
Lacrimation increased |
31/442 (7.01%)
|
405 |
2/443 (0.45%)
|
12 |
Gastrointestinal disorders |
|
|
Abdominal pain |
42/442 (9.50%)
|
171 |
39/443 (8.80%)
|
113 |
Constipation |
181/442 (40.95%)
|
1380 |
166/443 (37.47%)
|
931 |
Diarrhoea |
100/442 (22.62%)
|
536 |
118/443 (26.64%)
|
338 |
Dyspepsia |
49/442 (11.09%)
|
419 |
30/443 (6.77%)
|
155 |
Gastrooesophageal reflux disease |
25/442 (5.66%)
|
249 |
22/443 (4.97%)
|
178 |
Nausea |
236/442 (53.39%)
|
1465 |
223/443 (50.34%)
|
1157 |
Stomatitis |
61/442 (13.80%)
|
321 |
44/443 (9.93%)
|
159 |
Vomiting |
114/442 (25.79%)
|
369 |
108/443 (24.38%)
|
310 |
General disorders |
|
|
Asthenia |
40/442 (9.05%)
|
230 |
29/443 (6.55%)
|
178 |
Fatigue |
268/442 (60.63%)
|
2793 |
257/443 (58.01%)
|
2273 |
Mucosal inflammation |
51/442 (11.54%)
|
229 |
35/443 (7.90%)
|
110 |
Oedema peripheral |
66/442 (14.93%)
|
466 |
40/443 (9.03%)
|
249 |
Pain |
22/442 (4.98%)
|
87 |
31/443 (7.00%)
|
196 |
Pyrexia |
35/442 (7.92%)
|
104 |
42/443 (9.48%)
|
57 |
Infections and infestations |
|
|
Sinusitis |
33/442 (7.47%)
|
111 |
19/443 (4.29%)
|
53 |
Upper respiratory tract infection |
32/442 (7.24%)
|
103 |
26/443 (5.87%)
|
53 |
Urinary tract infection |
32/442 (7.24%)
|
84 |
42/443 (9.48%)
|
108 |
Investigations |
|
|
Alanine aminotransferase increased |
37/442 (8.37%)
|
291 |
12/443 (2.71%)
|
47 |
Aspartate aminotransferase increased |
33/442 (7.47%)
|
207 |
17/443 (3.84%)
|
52 |
Blood creatinine increased |
25/442 (5.66%)
|
163 |
13/443 (2.93%)
|
29 |
Haemoglobin decreased |
39/442 (8.82%)
|
322 |
22/443 (4.97%)
|
102 |
Platelet count decreased |
29/442 (6.56%)
|
106 |
14/443 (3.16%)
|
39 |
Weight decreased |
77/442 (17.42%)
|
464 |
68/443 (15.35%)
|
470 |
Metabolism and nutrition disorders |
|
|
Decreased appetite |
133/442 (30.09%)
|
865 |
145/443 (32.73%)
|
912 |
Dehydration |
68/442 (15.38%)
|
194 |
54/443 (12.19%)
|
155 |
Hyperglycaemia |
38/442 (8.60%)
|
251 |
45/443 (10.16%)
|
236 |
Hypokalaemia |
28/442 (6.33%)
|
70 |
33/443 (7.45%)
|
76 |
Hypomagnesaemia |
34/442 (7.69%)
|
169 |
30/443 (6.77%)
|
186 |
Musculoskeletal and connective tissue disorders |
|
|
Arthralgia |
46/442 (10.41%)
|
272 |
107/443 (24.15%)
|
967 |
Back pain |
60/442 (13.57%)
|
299 |
64/443 (14.45%)
|
441 |
Bone pain |
16/442 (3.62%)
|
83 |
33/443 (7.45%)
|
204 |
Musculoskeletal chest pain |
33/442 (7.47%)
|
197 |
21/443 (4.74%)
|
141 |
Musculoskeletal pain |
42/442 (9.50%)
|
273 |
31/443 (7.00%)
|
246 |
Myalgia |
25/442 (5.66%)
|
150 |
60/443 (13.54%)
|
394 |
Pain in extremity |
25/442 (5.66%)
|
200 |
44/443 (9.93%)
|
413 |
Nervous system disorders |
|
|
Dizziness |
77/442 (17.42%)
|
404 |
63/443 (14.22%)
|
298 |
Dysgeusia |
67/442 (15.16%)
|
551 |
47/443 (10.61%)
|
283 |
Headache |
82/442 (18.55%)
|
516 |
67/443 (15.12%)
|
343 |
Neuropathy peripheral |
42/442 (9.50%)
|
413 |
145/443 (32.73%)
|
1394 |
Paraesthesia |
11/442 (2.49%)
|
85 |
24/443 (5.42%)
|
255 |
Peripheral sensory neuropathy |
19/442 (4.30%)
|
218 |
73/443 (16.48%)
|
888 |
Psychiatric disorders |
|
|
Anxiety |
52/442 (11.76%)
|
407 |
44/443 (9.93%)
|
379 |
Confusional state |
19/442 (4.30%)
|
95 |
23/443 (5.19%)
|
48 |
Depression |
52/442 (11.76%)
|
402 |
47/443 (10.61%)
|
414 |
Insomnia |
69/442 (15.61%)
|
535 |
87/443 (19.64%)
|
719 |
Renal and urinary disorders |
|
|
Proteinuria |
63/442 (14.25%)
|
435 |
54/443 (12.19%)
|
449 |
Respiratory, thoracic and mediastinal disorders |
|
|
Cough |
91/442 (20.59%)
|
549 |
86/443 (19.41%)
|
568 |
Dysphonia |
32/442 (7.24%)
|
257 |
17/443 (3.84%)
|
126 |
Dyspnoea |
88/442 (19.91%)
|
558 |
85/443 (19.19%)
|
503 |
Epistaxis |
117/442 (26.47%)
|
800 |
98/443 (22.12%)
|
599 |
Oropharyngeal pain |
41/442 (9.28%)
|
140 |
33/443 (7.45%)
|
115 |
Rhinorrhoea |
29/442 (6.56%)
|
205 |
19/443 (4.29%)
|
153 |
Skin and subcutaneous tissue disorders |
|
|
Alopecia |
34/442 (7.69%)
|
445 |
193/443 (43.57%)
|
2024 |
Pruritus |
15/442 (3.39%)
|
72 |
30/443 (6.77%)
|
91 |
Rash |
42/442 (9.50%)
|
239 |
56/443 (12.64%)
|
177 |
Vascular disorders |
|
|
Hypertension |
74/442 (16.74%)
|
800 |
70/443 (15.80%)
|
678 |
Indicates events were collected by systematic assessment
Term from vocabulary, MedDRA 14.1
|