Time Frame |
From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
|
Adverse Event Reporting Description |
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
|
|
Arm/Group Title
|
Arm C (Bev+CP)
|
Arm B (Atezo+Bev+CP)
|
Arm A (Atezo+CP)
|
Arm/Group Description |
Bevacizumab+Paclitaxel+Carboplatin
|
Atezolizumab+Bevacizumab+Paclitaxel...
|
Atezolizumab+Paclitaxel+Carboplatin
|
Arm/Group Description |
Bevacizumab+Paclitaxel+Carboplatin
|
Atezolizumab+Bevacizumab+Paclitaxel+Carboplatin
|
Atezolizumab+Paclitaxel+Carboplatin
|
|
|
Arm C (Bev+CP)
|
Arm B (Atezo+Bev+CP)
|
Arm A (Atezo+CP)
|
|
Affected / at Risk (%) |
|
Affected / at Risk (%) |
|
Affected / at Risk (%) |
|
Total |
311/394 (78.93%)
|
|
285/393 (72.52%)
|
|
293/400 (73.25%)
|
|
|
|
Arm C (Bev+CP)
|
Arm B (Atezo+Bev+CP)
|
Arm A (Atezo+CP)
|
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Total |
142/394 (36.04%)
|
|
190/393 (48.35%)
|
|
170/400 (42.50%)
|
|
Blood and lymphatic system disorders |
|
|
|
ANAEMIA |
4/394 (1.02%)
|
4 |
5/393 (1.27%)
|
5 |
5/400 (1.25%)
|
6 |
BONE MARROW FAILURE |
1/394 (0.25%)
|
1 |
0/393 (0.00%)
|
0 |
0/400 (0.00%)
|
0 |
FEBRILE NEUTROPENIA |
17/394 (4.31%)
|
18 |
27/393 (6.87%)
|
30 |
13/400 (3.25%)
|
13 |
LEUKOPENIA |
1/394 (0.25%)
|
1 |
0/393 (0.00%)
|
0 |
0/400 (0.00%)
|
0 |
MYELOSUPPRESSION |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
0/400 (0.00%)
|
0 |
NEUTROPENIA |
2/394 (0.51%)
|
2 |
4/393 (1.02%)
|
4 |
1/400 (0.25%)
|
1 |
NORMOCHROMIC ANAEMIA |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
0/400 (0.00%)
|
0 |
PANCYTOPENIA |
2/394 (0.51%)
|
2 |
1/393 (0.25%)
|
1 |
0/400 (0.00%)
|
0 |
SPONTANEOUS HAEMATOMA |
0/394 (0.00%)
|
0 |
0/393 (0.00%)
|
0 |
1/400 (0.25%)
|
1 |
THROMBOCYTOPENIA |
2/394 (0.51%)
|
2 |
6/393 (1.53%)
|
6 |
1/400 (0.25%)
|
1 |
Cardiac disorders |
|
|
|
ACUTE MYOCARDIAL INFARCTION |
3/394 (0.76%)
|
3 |
2/393 (0.51%)
|
2 |
1/400 (0.25%)
|
1 |
ATRIAL FIBRILLATION |
1/394 (0.25%)
|
1 |
2/393 (0.51%)
|
2 |
2/400 (0.50%)
|
2 |
ATRIAL FLUTTER |
1/394 (0.25%)
|
1 |
0/393 (0.00%)
|
0 |
0/400 (0.00%)
|
0 |
ATRIOVENTRICULAR BLOCK SECOND DEGREE |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
0/400 (0.00%)
|
0 |
AUTOIMMUNE MYOCARDITIS |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
0/400 (0.00%)
|
0 |
CARDIAC ARREST |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
1/400 (0.25%)
|
1 |
CARDIAC FAILURE |
1/394 (0.25%)
|
1 |
2/393 (0.51%)
|
2 |
0/400 (0.00%)
|
0 |
CARDIAC FAILURE CONGESTIVE |
1/394 (0.25%)
|
1 |
0/393 (0.00%)
|
0 |
0/400 (0.00%)
|
0 |
CORONARY ARTERY DISEASE |
1/394 (0.25%)
|
1 |
0/393 (0.00%)
|
0 |
0/400 (0.00%)
|
0 |
LEFT VENTRICULAR DYSFUNCTION |
1/394 (0.25%)
|
1 |
0/393 (0.00%)
|
0 |
0/400 (0.00%)
|
0 |
MYOCARDIAL INFARCTION |
1/394 (0.25%)
|
1 |
1/393 (0.25%)
|
3 |
2/400 (0.50%)
|
2 |
MYOCARDIAL ISCHAEMIA |
0/394 (0.00%)
|
0 |
0/393 (0.00%)
|
0 |
1/400 (0.25%)
|
1 |
PERICARDIAL EFFUSION |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
0/400 (0.00%)
|
0 |
PERICARDITIS |
1/394 (0.25%)
|
1 |
0/393 (0.00%)
|
0 |
0/400 (0.00%)
|
0 |
TACHYARRHYTHMIA |
0/394 (0.00%)
|
0 |
0/393 (0.00%)
|
0 |
1/400 (0.25%)
|
1 |
VENTRICULAR TACHYCARDIA |
1/394 (0.25%)
|
1 |
0/393 (0.00%)
|
0 |
0/400 (0.00%)
|
0 |
Endocrine disorders |
|
|
|
ADRENAL INSUFFICIENCY |
1/394 (0.25%)
|
1 |
2/393 (0.51%)
|
2 |
1/400 (0.25%)
|
1 |
ADRENOCORTICAL INSUFFICIENCY ACUTE |
0/394 (0.00%)
|
0 |
0/393 (0.00%)
|
0 |
1/400 (0.25%)
|
1 |
DIABETES INSIPIDUS |
0/394 (0.00%)
|
0 |
0/393 (0.00%)
|
0 |
1/400 (0.25%)
|
1 |
HYPOPHYSITIS |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
0/400 (0.00%)
|
0 |
HYPOTHYROIDISM |
0/394 (0.00%)
|
0 |
0/393 (0.00%)
|
0 |
1/400 (0.25%)
|
1 |
INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
0/400 (0.00%)
|
0 |
SECONDARY ADRENOCORTICAL INSUFFICIENCY |
0/394 (0.00%)
|
0 |
0/393 (0.00%)
|
0 |
1/400 (0.25%)
|
1 |
Eye disorders |
|
|
|
OPTIC NEUROPATHY |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
0/400 (0.00%)
|
0 |
Gastrointestinal disorders |
|
|
|
ABDOMINAL PAIN |
3/394 (0.76%)
|
3 |
1/393 (0.25%)
|
1 |
2/400 (0.50%)
|
2 |
ABDOMINAL PAIN LOWER |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
1/400 (0.25%)
|
1 |
ABDOMINAL PAIN UPPER |
1/394 (0.25%)
|
1 |
0/393 (0.00%)
|
0 |
0/400 (0.00%)
|
0 |
COLITIS |
0/394 (0.00%)
|
0 |
6/393 (1.53%)
|
6 |
1/400 (0.25%)
|
1 |
COLITIS ISCHAEMIC |
2/394 (0.51%)
|
2 |
1/393 (0.25%)
|
1 |
0/400 (0.00%)
|
0 |
CONSTIPATION |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
1/400 (0.25%)
|
1 |
DIARRHOEA |
3/394 (0.76%)
|
3 |
10/393 (2.54%)
|
11 |
8/400 (2.00%)
|
8 |
DIVERTICULAR PERFORATION |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
1/400 (0.25%)
|
1 |
DUODENAL ULCER |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
0/400 (0.00%)
|
0 |
DYSPHAGIA |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
2/400 (0.50%)
|
3 |
FAECALOMA |
1/394 (0.25%)
|
1 |
0/393 (0.00%)
|
0 |
0/400 (0.00%)
|
0 |
FOOD POISONING |
0/394 (0.00%)
|
0 |
0/393 (0.00%)
|
0 |
1/400 (0.25%)
|
1 |
GASTRIC HAEMORRHAGE |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
0/400 (0.00%)
|
0 |
GASTRITIS |
0/394 (0.00%)
|
0 |
4/393 (1.02%)
|
4 |
0/400 (0.00%)
|
0 |
GASTROINTESTINAL HAEMORRHAGE |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
2/400 (0.50%)
|
2 |
GLOSSODYNIA |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
0/400 (0.00%)
|
0 |
ILEUS PARALYTIC |
1/394 (0.25%)
|
1 |
0/393 (0.00%)
|
0 |
0/400 (0.00%)
|
0 |
INGUINAL HERNIA |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
0/400 (0.00%)
|
0 |
INTESTINAL ANGINA |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
0/400 (0.00%)
|
0 |
INTESTINAL HAEMORRHAGE |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
2 |
0/400 (0.00%)
|
0 |
INTESTINAL INFARCTION |
0/394 (0.00%)
|
0 |
0/393 (0.00%)
|
0 |
1/400 (0.25%)
|
1 |
INTESTINAL ISCHAEMIA |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
0/400 (0.00%)
|
0 |
INTESTINAL OBSTRUCTION |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
0/400 (0.00%)
|
0 |
INTESTINAL PERFORATION |
2/394 (0.51%)
|
2 |
0/393 (0.00%)
|
0 |
0/400 (0.00%)
|
0 |
IRRITABLE BOWEL SYNDROME |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
0/400 (0.00%)
|
0 |
LARGE INTESTINAL HAEMORRHAGE |
1/394 (0.25%)
|
1 |
0/393 (0.00%)
|
0 |
0/400 (0.00%)
|
0 |
LARGE INTESTINE PERFORATION |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
0/400 (0.00%)
|
0 |
NAUSEA |
3/394 (0.76%)
|
3 |
7/393 (1.78%)
|
7 |
1/400 (0.25%)
|
1 |
OESOPHAGEAL FOOD IMPACTION |
0/394 (0.00%)
|
0 |
0/393 (0.00%)
|
0 |
1/400 (0.25%)
|
1 |
PANCREATITIS ACUTE |
0/394 (0.00%)
|
0 |
0/393 (0.00%)
|
0 |
1/400 (0.25%)
|
1 |
VOMITING |
3/394 (0.76%)
|
3 |
5/393 (1.27%)
|
5 |
4/400 (1.00%)
|
5 |
General disorders |
|
|
|
ASTHENIA |
1/394 (0.25%)
|
1 |
0/393 (0.00%)
|
0 |
1/400 (0.25%)
|
1 |
CATHETER SITE ERYTHEMA |
0/394 (0.00%)
|
0 |
0/393 (0.00%)
|
0 |
1/400 (0.25%)
|
1 |
CHEST PAIN |
6/394 (1.52%)
|
7 |
4/393 (1.02%)
|
4 |
1/400 (0.25%)
|
2 |
COMPLICATION ASSOCIATED WITH DEVICE |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
0/400 (0.00%)
|
0 |
DEATH |
2/394 (0.51%)
|
2 |
2/393 (0.51%)
|
2 |
1/400 (0.25%)
|
1 |
GENERAL PHYSICAL HEALTH DETERIORATION |
2/394 (0.51%)
|
2 |
2/393 (0.51%)
|
2 |
0/400 (0.00%)
|
0 |
INFLUENZA LIKE ILLNESS |
1/394 (0.25%)
|
1 |
0/393 (0.00%)
|
0 |
1/400 (0.25%)
|
1 |
INFUSION SITE EXTRAVASATION |
1/394 (0.25%)
|
1 |
0/393 (0.00%)
|
0 |
0/400 (0.00%)
|
0 |
MUCOSAL INFLAMMATION |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
0/400 (0.00%)
|
0 |
NON-CARDIAC CHEST PAIN |
1/394 (0.25%)
|
1 |
1/393 (0.25%)
|
1 |
0/400 (0.00%)
|
0 |
OEDEMA PERIPHERAL |
1/394 (0.25%)
|
1 |
1/393 (0.25%)
|
1 |
0/400 (0.00%)
|
0 |
PAIN |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
1/400 (0.25%)
|
1 |
PYREXIA |
1/394 (0.25%)
|
1 |
8/393 (2.04%)
|
8 |
6/400 (1.50%)
|
6 |
Hepatobiliary disorders |
|
|
|
CHOLANGITIS |
1/394 (0.25%)
|
1 |
3/393 (0.76%)
|
3 |
0/400 (0.00%)
|
0 |
CHOLANGITIS ACUTE |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
0/400 (0.00%)
|
0 |
CHOLELITHIASIS |
0/394 (0.00%)
|
0 |
0/393 (0.00%)
|
0 |
1/400 (0.25%)
|
1 |
HEPATITIS |
0/394 (0.00%)
|
0 |
2/393 (0.51%)
|
2 |
1/400 (0.25%)
|
1 |
HEPATOMEGALY |
0/394 (0.00%)
|
0 |
0/393 (0.00%)
|
0 |
1/400 (0.25%)
|
1 |
HEPATOTOXICITY |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
0/400 (0.00%)
|
0 |
Immune system disorders |
|
|
|
ANAPHYLACTIC REACTION |
0/394 (0.00%)
|
0 |
0/393 (0.00%)
|
0 |
2/400 (0.50%)
|
2 |
DRUG HYPERSENSITIVITY |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
2 |
2/400 (0.50%)
|
2 |
HYPERSENSITIVITY |
2/394 (0.51%)
|
2 |
1/393 (0.25%)
|
2 |
1/400 (0.25%)
|
1 |
Infections and infestations |
|
|
|
ABDOMINAL SEPSIS |
0/394 (0.00%)
|
0 |
0/393 (0.00%)
|
0 |
1/400 (0.25%)
|
1 |
ANAL ABSCESS |
1/394 (0.25%)
|
1 |
1/393 (0.25%)
|
1 |
1/400 (0.25%)
|
1 |
BACTERAEMIA |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
1/400 (0.25%)
|
1 |
BACTERIAL INFECTION |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
0/400 (0.00%)
|
0 |
BONE ABSCESS |
1/394 (0.25%)
|
1 |
0/393 (0.00%)
|
0 |
0/400 (0.00%)
|
0 |
BRONCHITIS |
2/394 (0.51%)
|
2 |
4/393 (1.02%)
|
4 |
1/400 (0.25%)
|
1 |
BURSITIS INFECTIVE |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
0/400 (0.00%)
|
0 |
CELLULITIS |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
0/400 (0.00%)
|
0 |
CHRONIC SINUSITIS |
1/394 (0.25%)
|
1 |
0/393 (0.00%)
|
0 |
0/400 (0.00%)
|
0 |
CLOSTRIDIUM DIFFICILE INFECTION |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
0/400 (0.00%)
|
0 |
DEVICE RELATED INFECTION |
0/394 (0.00%)
|
0 |
0/393 (0.00%)
|
0 |
2/400 (0.50%)
|
2 |
DIVERTICULITIS |
1/394 (0.25%)
|
1 |
1/393 (0.25%)
|
2 |
1/400 (0.25%)
|
1 |
EMPYEMA |
0/394 (0.00%)
|
0 |
0/393 (0.00%)
|
0 |
2/400 (0.50%)
|
2 |
ENCEPHALITIS |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
1/400 (0.25%)
|
1 |
ENDOCARDITIS BACTERIAL |
0/394 (0.00%)
|
0 |
0/393 (0.00%)
|
0 |
1/400 (0.25%)
|
1 |
ENTERITIS INFECTIOUS |
1/394 (0.25%)
|
1 |
0/393 (0.00%)
|
0 |
0/400 (0.00%)
|
0 |
ENTEROCOLITIS BACTERIAL |
0/394 (0.00%)
|
0 |
0/393 (0.00%)
|
0 |
1/400 (0.25%)
|
1 |
FEBRILE INFECTION |
1/394 (0.25%)
|
1 |
0/393 (0.00%)
|
0 |
1/400 (0.25%)
|
1 |
GASTROENTERITIS |
0/394 (0.00%)
|
0 |
0/393 (0.00%)
|
0 |
1/400 (0.25%)
|
1 |
GASTROENTERITIS CLOSTRIDIAL |
0/394 (0.00%)
|
0 |
0/393 (0.00%)
|
0 |
1/400 (0.25%)
|
1 |
HAEMORRHAGIC PNEUMONIA |
1/394 (0.25%)
|
1 |
0/393 (0.00%)
|
0 |
0/400 (0.00%)
|
0 |
HEPATITIS A |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
0/400 (0.00%)
|
0 |
HEPATITIS C |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
0/400 (0.00%)
|
0 |
HERPES ZOSTER |
0/394 (0.00%)
|
0 |
0/393 (0.00%)
|
0 |
2/400 (0.50%)
|
2 |
INFECTED SKIN ULCER |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
0/400 (0.00%)
|
0 |
INFECTION |
0/394 (0.00%)
|
0 |
0/393 (0.00%)
|
0 |
1/400 (0.25%)
|
1 |
INFECTIOUS PLEURAL EFFUSION |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
0/400 (0.00%)
|
0 |
INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
1/400 (0.25%)
|
1 |
INFLUENZA |
0/394 (0.00%)
|
0 |
0/393 (0.00%)
|
0 |
1/400 (0.25%)
|
1 |
KLEBSIELLA SEPSIS |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
0/400 (0.00%)
|
0 |
LARGE INTESTINE INFECTION |
0/394 (0.00%)
|
0 |
2/393 (0.51%)
|
2 |
0/400 (0.00%)
|
0 |
LOWER RESPIRATORY TRACT INFECTION |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
3/400 (0.75%)
|
4 |
NEUTROPENIC SEPSIS |
0/394 (0.00%)
|
0 |
0/393 (0.00%)
|
0 |
1/400 (0.25%)
|
1 |
OSTEOMYELITIS |
1/394 (0.25%)
|
1 |
0/393 (0.00%)
|
0 |
0/400 (0.00%)
|
0 |
PARAINFLUENZAE VIRUS INFECTION |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
0/400 (0.00%)
|
0 |
PAROTITIS |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
0/400 (0.00%)
|
0 |
PNEUMONIA |
18/394 (4.57%)
|
19 |
28/393 (7.12%)
|
30 |
21/400 (5.25%)
|
23 |
PNEUMONIA ADENOVIRAL |
0/394 (0.00%)
|
0 |
0/393 (0.00%)
|
0 |
1/400 (0.25%)
|
1 |
PNEUMONIA BACTERIAL |
0/394 (0.00%)
|
0 |
3/393 (0.76%)
|
3 |
0/400 (0.00%)
|
0 |
PROSTATIC ABSCESS |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
0/400 (0.00%)
|
0 |
PYOPNEUMOTHORAX |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
0/400 (0.00%)
|
0 |
RESPIRATORY SYNCYTIAL VIRUS BRONCHITIS |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
0/400 (0.00%)
|
0 |
RESPIRATORY SYNCYTIAL VIRUS INFECTION |
0/394 (0.00%)
|
0 |
0/393 (0.00%)
|
0 |
1/400 (0.25%)
|
1 |
RESPIRATORY TRACT INFECTION |
3/394 (0.76%)
|
3 |
4/393 (1.02%)
|
4 |
2/400 (0.50%)
|
2 |
RESPIRATORY TRACT INFECTION FUNGAL |
1/394 (0.25%)
|
1 |
0/393 (0.00%)
|
0 |
0/400 (0.00%)
|
0 |
SALMONELLOSIS |
0/394 (0.00%)
|
0 |
0/393 (0.00%)
|
0 |
1/400 (0.25%)
|
1 |
SCROTAL ABSCESS |
1/394 (0.25%)
|
1 |
0/393 (0.00%)
|
0 |
0/400 (0.00%)
|
0 |
SEPSIS |
5/394 (1.27%)
|
5 |
3/393 (0.76%)
|
4 |
3/400 (0.75%)
|
3 |
SEPTIC SHOCK |
0/394 (0.00%)
|
0 |
2/393 (0.51%)
|
2 |
2/400 (0.50%)
|
2 |
STAPHYLOCOCCAL BACTERAEMIA |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
0/400 (0.00%)
|
0 |
STAPHYLOCOCCAL INFECTION |
1/394 (0.25%)
|
1 |
0/393 (0.00%)
|
0 |
0/400 (0.00%)
|
0 |
TOOTH ABSCESS |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
0/400 (0.00%)
|
0 |
UPPER RESPIRATORY TRACT INFECTION |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
1/400 (0.25%)
|
1 |
URINARY TRACT INFECTION |
3/394 (0.76%)
|
3 |
3/393 (0.76%)
|
3 |
4/400 (1.00%)
|
4 |
VASCULAR DEVICE INFECTION |
0/394 (0.00%)
|
0 |
2/393 (0.51%)
|
2 |
1/400 (0.25%)
|
1 |
VIRAL INFECTION |
0/394 (0.00%)
|
0 |
3/393 (0.76%)
|
3 |
0/400 (0.00%)
|
0 |
Injury, poisoning and procedural complications |
|
|
|
ACCIDENTAL OVERDOSE |
0/394 (0.00%)
|
0 |
0/393 (0.00%)
|
0 |
1/400 (0.25%)
|
1 |
FALL |
0/394 (0.00%)
|
0 |
2/393 (0.51%)
|
2 |
0/400 (0.00%)
|
0 |
FEMUR FRACTURE |
1/394 (0.25%)
|
1 |
1/393 (0.25%)
|
1 |
2/400 (0.50%)
|
2 |
FRACTURE |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
0/400 (0.00%)
|
0 |
HIP FRACTURE |
0/394 (0.00%)
|
0 |
2/393 (0.51%)
|
2 |
2/400 (0.50%)
|
2 |
HUMERUS FRACTURE |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
0/400 (0.00%)
|
0 |
INFUSION RELATED REACTION |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
3/400 (0.75%)
|
3 |
PROCEDURAL COMPLICATION |
0/394 (0.00%)
|
0 |
2/393 (0.51%)
|
2 |
0/400 (0.00%)
|
0 |
PROCEDURAL PAIN |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
0/400 (0.00%)
|
0 |
RIB FRACTURE |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
0/400 (0.00%)
|
0 |
SPINAL COMPRESSION FRACTURE |
0/394 (0.00%)
|
0 |
0/393 (0.00%)
|
0 |
1/400 (0.25%)
|
1 |
STERNAL FRACTURE |
1/394 (0.25%)
|
1 |
0/393 (0.00%)
|
0 |
0/400 (0.00%)
|
0 |
WOUND COMPLICATION |
1/394 (0.25%)
|
1 |
0/393 (0.00%)
|
0 |
0/400 (0.00%)
|
0 |
Investigations |
|
|
|
ALANINE AMINOTRANSFERASE INCREASED |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
0/400 (0.00%)
|
0 |
ASPARTATE AMINOTRANSFERASE INCREASED |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
0/400 (0.00%)
|
0 |
BLOOD LACTATE DEHYDROGENASE INCREASED |
0/394 (0.00%)
|
0 |
0/393 (0.00%)
|
0 |
1/400 (0.25%)
|
1 |
BLOOD PRESSURE INCREASED |
1/394 (0.25%)
|
1 |
0/393 (0.00%)
|
0 |
0/400 (0.00%)
|
0 |
C-REACTIVE PROTEIN INCREASED |
0/394 (0.00%)
|
0 |
0/393 (0.00%)
|
0 |
1/400 (0.25%)
|
1 |
GENERAL PHYSICAL CONDITION ABNORMAL |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
0/400 (0.00%)
|
0 |
HEPATIC ENZYME INCREASED |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
0/400 (0.00%)
|
0 |
LIPASE INCREASED |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
0/400 (0.00%)
|
0 |
NEUTROPHIL COUNT DECREASED |
1/394 (0.25%)
|
1 |
0/393 (0.00%)
|
0 |
0/400 (0.00%)
|
0 |
PLATELET COUNT DECREASED |
2/394 (0.51%)
|
2 |
2/393 (0.51%)
|
2 |
0/400 (0.00%)
|
0 |
TRANSAMINASES INCREASED |
0/394 (0.00%)
|
0 |
0/393 (0.00%)
|
0 |
1/400 (0.25%)
|
1 |
TROPONIN INCREASED |
1/394 (0.25%)
|
1 |
0/393 (0.00%)
|
0 |
0/400 (0.00%)
|
0 |
WEIGHT DECREASED |
0/394 (0.00%)
|
0 |
0/393 (0.00%)
|
0 |
1/400 (0.25%)
|
1 |
WHITE BLOOD CELL COUNT DECREASED |
1/394 (0.25%)
|
1 |
2/393 (0.51%)
|
2 |
0/400 (0.00%)
|
0 |
Metabolism and nutrition disorders |
|
|
|
DECREASED APPETITE |
0/394 (0.00%)
|
0 |
2/393 (0.51%)
|
2 |
0/400 (0.00%)
|
0 |
DEHYDRATION |
6/394 (1.52%)
|
6 |
7/393 (1.78%)
|
9 |
3/400 (0.75%)
|
3 |
FAILURE TO THRIVE |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
0/400 (0.00%)
|
0 |
HYPERCALCAEMIA |
0/394 (0.00%)
|
0 |
0/393 (0.00%)
|
0 |
1/400 (0.25%)
|
1 |
HYPERGLYCAEMIA |
1/394 (0.25%)
|
2 |
0/393 (0.00%)
|
0 |
0/400 (0.00%)
|
0 |
HYPOKALAEMIA |
0/394 (0.00%)
|
0 |
2/393 (0.51%)
|
2 |
1/400 (0.25%)
|
1 |
HYPONATRAEMIA |
1/394 (0.25%)
|
1 |
2/393 (0.51%)
|
2 |
1/400 (0.25%)
|
1 |
HYPOPHOSPHATAEMIA |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
0/400 (0.00%)
|
0 |
Musculoskeletal and connective tissue disorders |
|
|
|
ARTHRALGIA |
2/394 (0.51%)
|
2 |
2/393 (0.51%)
|
2 |
3/400 (0.75%)
|
3 |
BACK PAIN |
3/394 (0.76%)
|
3 |
2/393 (0.51%)
|
2 |
1/400 (0.25%)
|
1 |
BONE PAIN |
1/394 (0.25%)
|
1 |
0/393 (0.00%)
|
0 |
0/400 (0.00%)
|
0 |
COMPARTMENT SYNDROME |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
0/400 (0.00%)
|
0 |
FLANK PAIN |
0/394 (0.00%)
|
0 |
0/393 (0.00%)
|
0 |
2/400 (0.50%)
|
2 |
MUSCULAR WEAKNESS |
1/394 (0.25%)
|
1 |
1/393 (0.25%)
|
1 |
0/400 (0.00%)
|
0 |
MUSCULOSKELETAL CHEST PAIN |
1/394 (0.25%)
|
1 |
0/393 (0.00%)
|
0 |
0/400 (0.00%)
|
0 |
MYALGIA |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
0/400 (0.00%)
|
0 |
OSTEOLYSIS |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
0/400 (0.00%)
|
0 |
PAIN IN EXTREMITY |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
1/400 (0.25%)
|
1 |
SOFT TISSUE NECROSIS |
0/394 (0.00%)
|
0 |
0/393 (0.00%)
|
0 |
1/400 (0.25%)
|
1 |
SPINAL PAIN |
0/394 (0.00%)
|
0 |
0/393 (0.00%)
|
0 |
1/400 (0.25%)
|
1 |
VERTEBRAL FORAMINAL STENOSIS |
0/394 (0.00%)
|
0 |
0/393 (0.00%)
|
0 |
1/400 (0.25%)
|
1 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
|
|
ADENOCARCINOMA GASTRIC |
0/394 (0.00%)
|
0 |
0/393 (0.00%)
|
0 |
1/400 (0.25%)
|
1 |
B-CELL LYMPHOMA |
0/394 (0.00%)
|
0 |
0/393 (0.00%)
|
0 |
1/400 (0.25%)
|
1 |
BLADDER NEOPLASM |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
0/400 (0.00%)
|
0 |
BLADDER TRANSITIONAL CELL CARCINOMA |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
0/400 (0.00%)
|
0 |
MARROW HYPERPLASIA |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
0/400 (0.00%)
|
0 |
MENINGIOMA |
0/394 (0.00%)
|
0 |
0/393 (0.00%)
|
0 |
1/400 (0.25%)
|
1 |
METASTASES TO MENINGES |
0/394 (0.00%)
|
0 |
0/393 (0.00%)
|
0 |
1/400 (0.25%)
|
1 |
TUMOUR PAIN |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
0/400 (0.00%)
|
0 |
TUMOUR PSEUDOPROGRESSION |
0/394 (0.00%)
|
0 |
0/393 (0.00%)
|
0 |
1/400 (0.25%)
|
1 |
Nervous system disorders |
|
|
|
ATAXIA |
1/394 (0.25%)
|
1 |
0/393 (0.00%)
|
0 |
1/400 (0.25%)
|
1 |
CEREBRAL HAEMORRHAGE |
1/394 (0.25%)
|
1 |
0/393 (0.00%)
|
0 |
0/400 (0.00%)
|
0 |
CEREBRAL INFARCTION |
1/394 (0.25%)
|
1 |
1/393 (0.25%)
|
1 |
1/400 (0.25%)
|
1 |
CEREBRAL ISCHAEMIA |
0/394 (0.00%)
|
0 |
2/393 (0.51%)
|
2 |
1/400 (0.25%)
|
1 |
CEREBROVASCULAR ACCIDENT |
1/394 (0.25%)
|
1 |
5/393 (1.27%)
|
5 |
2/400 (0.50%)
|
2 |
COGNITIVE DISORDER |
0/394 (0.00%)
|
0 |
0/393 (0.00%)
|
0 |
1/400 (0.25%)
|
1 |
DEPRESSED LEVEL OF CONSCIOUSNESS |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
0/400 (0.00%)
|
0 |
DIZZINESS |
1/394 (0.25%)
|
1 |
1/393 (0.25%)
|
1 |
0/400 (0.00%)
|
0 |
DIZZINESS POSTURAL |
1/394 (0.25%)
|
1 |
0/393 (0.00%)
|
0 |
0/400 (0.00%)
|
0 |
DYSAESTHESIA |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
0/400 (0.00%)
|
0 |
ENCEPHALOPATHY |
1/394 (0.25%)
|
1 |
0/393 (0.00%)
|
0 |
1/400 (0.25%)
|
1 |
FOCAL DYSCOGNITIVE SEIZURES |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
0/400 (0.00%)
|
0 |
HAEMORRHAGE INTRACRANIAL |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
1/400 (0.25%)
|
1 |
HEADACHE |
0/394 (0.00%)
|
0 |
2/393 (0.51%)
|
2 |
0/400 (0.00%)
|
0 |
HEMIPARESIS |
0/394 (0.00%)
|
0 |
0/393 (0.00%)
|
0 |
1/400 (0.25%)
|
1 |
ISCHAEMIC STROKE |
4/394 (1.02%)
|
4 |
1/393 (0.25%)
|
1 |
2/400 (0.50%)
|
2 |
LOSS OF CONSCIOUSNESS |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
1/400 (0.25%)
|
1 |
METABOLIC ENCEPHALOPATHY |
1/394 (0.25%)
|
1 |
1/393 (0.25%)
|
1 |
0/400 (0.00%)
|
0 |
NEUROPATHY PERIPHERAL |
1/394 (0.25%)
|
1 |
1/393 (0.25%)
|
1 |
0/400 (0.00%)
|
0 |
PARTIAL SEIZURES |
0/394 (0.00%)
|
0 |
0/393 (0.00%)
|
0 |
2/400 (0.50%)
|
2 |
PERIPHERAL SENSORY NEUROPATHY |
2/394 (0.51%)
|
2 |
0/393 (0.00%)
|
0 |
1/400 (0.25%)
|
1 |
POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME |
2/394 (0.51%)
|
2 |
0/393 (0.00%)
|
0 |
0/400 (0.00%)
|
0 |
PRESYNCOPE |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
0/400 (0.00%)
|
0 |
SEIZURE |
1/394 (0.25%)
|
1 |
5/393 (1.27%)
|
5 |
2/400 (0.50%)
|
3 |
SOMNOLENCE |
0/394 (0.00%)
|
0 |
0/393 (0.00%)
|
0 |
1/400 (0.25%)
|
1 |
SPINAL CORD COMPRESSION |
0/394 (0.00%)
|
0 |
0/393 (0.00%)
|
0 |
1/400 (0.25%)
|
1 |
SYNCOPE |
2/394 (0.51%)
|
2 |
1/393 (0.25%)
|
1 |
1/400 (0.25%)
|
1 |
TRANSIENT ISCHAEMIC ATTACK |
1/394 (0.25%)
|
1 |
2/393 (0.51%)
|
2 |
0/400 (0.00%)
|
0 |
Psychiatric disorders |
|
|
|
ALCOHOL WITHDRAWAL SYNDROME |
0/394 (0.00%)
|
0 |
0/393 (0.00%)
|
0 |
1/400 (0.25%)
|
1 |
ANXIETY |
1/394 (0.25%)
|
1 |
1/393 (0.25%)
|
2 |
0/400 (0.00%)
|
0 |
BIPOLAR DISORDER |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
0/400 (0.00%)
|
0 |
CONFUSIONAL STATE |
2/394 (0.51%)
|
2 |
1/393 (0.25%)
|
1 |
1/400 (0.25%)
|
1 |
DELIRIUM |
0/394 (0.00%)
|
0 |
0/393 (0.00%)
|
0 |
1/400 (0.25%)
|
1 |
DELUSION |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
0/400 (0.00%)
|
0 |
MENTAL STATUS CHANGES |
1/394 (0.25%)
|
1 |
1/393 (0.25%)
|
1 |
0/400 (0.00%)
|
0 |
PSYCHOTIC DISORDER |
0/394 (0.00%)
|
0 |
0/393 (0.00%)
|
0 |
1/400 (0.25%)
|
1 |
SUICIDAL IDEATION |
1/394 (0.25%)
|
1 |
0/393 (0.00%)
|
0 |
0/400 (0.00%)
|
0 |
Renal and urinary disorders |
|
|
|
ACUTE KIDNEY INJURY |
3/394 (0.76%)
|
3 |
3/393 (0.76%)
|
3 |
2/400 (0.50%)
|
2 |
GLOMERULONEPHROPATHY |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
0/400 (0.00%)
|
0 |
HAEMATURIA |
1/394 (0.25%)
|
1 |
0/393 (0.00%)
|
0 |
0/400 (0.00%)
|
0 |
NEPHROLITHIASIS |
0/394 (0.00%)
|
0 |
2/393 (0.51%)
|
2 |
0/400 (0.00%)
|
0 |
PRERENAL FAILURE |
0/394 (0.00%)
|
0 |
2/393 (0.51%)
|
2 |
0/400 (0.00%)
|
0 |
RENAL FAILURE |
0/394 (0.00%)
|
0 |
3/393 (0.76%)
|
3 |
0/400 (0.00%)
|
0 |
RENAL IMPAIRMENT |
0/394 (0.00%)
|
0 |
0/393 (0.00%)
|
0 |
1/400 (0.25%)
|
2 |
RENAL INJURY |
1/394 (0.25%)
|
1 |
0/393 (0.00%)
|
0 |
0/400 (0.00%)
|
0 |
TUBULOINTERSTITIAL NEPHRITIS |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
1/400 (0.25%)
|
1 |
URINARY TRACT OBSTRUCTION |
0/394 (0.00%)
|
0 |
0/393 (0.00%)
|
0 |
1/400 (0.25%)
|
1 |
Respiratory, thoracic and mediastinal disorders |
|
|
|
ACUTE RESPIRATORY DISTRESS SYNDROME |
0/394 (0.00%)
|
0 |
0/393 (0.00%)
|
0 |
1/400 (0.25%)
|
1 |
ACUTE RESPIRATORY FAILURE |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
3/400 (0.75%)
|
3 |
BRONCHOSTENOSIS |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
0/400 (0.00%)
|
0 |
CHRONIC OBSTRUCTIVE PULMONARY DISEASE |
2/394 (0.51%)
|
2 |
3/393 (0.76%)
|
3 |
3/400 (0.75%)
|
3 |
COUGH |
0/394 (0.00%)
|
0 |
3/393 (0.76%)
|
3 |
0/400 (0.00%)
|
0 |
DYSPNOEA |
6/394 (1.52%)
|
6 |
2/393 (0.51%)
|
2 |
4/400 (1.00%)
|
4 |
EPISTAXIS |
1/394 (0.25%)
|
1 |
1/393 (0.25%)
|
2 |
0/400 (0.00%)
|
0 |
HAEMOPTYSIS |
2/394 (0.51%)
|
2 |
8/393 (2.04%)
|
8 |
3/400 (0.75%)
|
4 |
HICCUPS |
1/394 (0.25%)
|
1 |
0/393 (0.00%)
|
0 |
0/400 (0.00%)
|
0 |
HYPOXIA |
1/394 (0.25%)
|
1 |
2/393 (0.51%)
|
2 |
2/400 (0.50%)
|
2 |
IMMUNE-MEDIATED PNEUMONITIS |
0/394 (0.00%)
|
0 |
0/393 (0.00%)
|
0 |
1/400 (0.25%)
|
1 |
INTERSTITIAL LUNG DISEASE |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
1/400 (0.25%)
|
1 |
PLEURAL EFFUSION |
2/394 (0.51%)
|
2 |
0/393 (0.00%)
|
0 |
3/400 (0.75%)
|
3 |
PLEURISY |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
2 |
1/400 (0.25%)
|
1 |
PLEURITIC PAIN |
1/394 (0.25%)
|
3 |
0/393 (0.00%)
|
0 |
0/400 (0.00%)
|
0 |
PNEUMONIA ASPIRATION |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
0/400 (0.00%)
|
0 |
PNEUMONITIS |
0/394 (0.00%)
|
0 |
7/393 (1.78%)
|
7 |
8/400 (2.00%)
|
8 |
PNEUMOTHORAX |
2/394 (0.51%)
|
3 |
0/393 (0.00%)
|
0 |
4/400 (1.00%)
|
4 |
PULMONARY EMBOLISM |
8/394 (2.03%)
|
8 |
5/393 (1.27%)
|
5 |
8/400 (2.00%)
|
8 |
PULMONARY HAEMORRHAGE |
4/394 (1.02%)
|
4 |
2/393 (0.51%)
|
2 |
0/400 (0.00%)
|
0 |
PULMONARY NECROSIS |
1/394 (0.25%)
|
1 |
0/393 (0.00%)
|
0 |
0/400 (0.00%)
|
0 |
PULMONARY OEDEMA |
0/394 (0.00%)
|
0 |
0/393 (0.00%)
|
0 |
2/400 (0.50%)
|
2 |
RESPIRATORY FAILURE |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
1/400 (0.25%)
|
1 |
Skin and subcutaneous tissue disorders |
|
|
|
DERMATITIS |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
1/400 (0.25%)
|
1 |
ERYTHEMA MULTIFORME |
0/394 (0.00%)
|
0 |
0/393 (0.00%)
|
0 |
3/400 (0.75%)
|
3 |
PEMPHIGOID |
0/394 (0.00%)
|
0 |
0/393 (0.00%)
|
0 |
1/400 (0.25%)
|
1 |
RASH |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
2 |
3/400 (0.75%)
|
3 |
RASH MACULO-PAPULAR |
0/394 (0.00%)
|
0 |
0/393 (0.00%)
|
0 |
1/400 (0.25%)
|
1 |
Surgical and medical procedures |
|
|
|
VERTEBROPLASTY |
1/394 (0.25%)
|
1 |
0/393 (0.00%)
|
0 |
0/400 (0.00%)
|
0 |
Vascular disorders |
|
|
|
ANEURYSM |
1/394 (0.25%)
|
1 |
0/393 (0.00%)
|
0 |
0/400 (0.00%)
|
0 |
AORTIC DISSECTION |
0/394 (0.00%)
|
0 |
2/393 (0.51%)
|
2 |
0/400 (0.00%)
|
0 |
ARTERIAL OCCLUSIVE DISEASE |
0/394 (0.00%)
|
0 |
0/393 (0.00%)
|
0 |
1/400 (0.25%)
|
1 |
DEEP VEIN THROMBOSIS |
1/394 (0.25%)
|
1 |
2/393 (0.51%)
|
2 |
1/400 (0.25%)
|
1 |
DIABETIC VASCULAR DISORDER |
0/394 (0.00%)
|
0 |
0/393 (0.00%)
|
0 |
1/400 (0.25%)
|
1 |
EMBOLISM |
0/394 (0.00%)
|
0 |
0/393 (0.00%)
|
0 |
2/400 (0.50%)
|
2 |
EMBOLISM VENOUS |
1/394 (0.25%)
|
1 |
0/393 (0.00%)
|
0 |
0/400 (0.00%)
|
0 |
HAEMATOMA |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
0/400 (0.00%)
|
0 |
HYPERTENSION |
1/394 (0.25%)
|
1 |
1/393 (0.25%)
|
1 |
0/400 (0.00%)
|
0 |
HYPOTENSION |
0/394 (0.00%)
|
0 |
2/393 (0.51%)
|
2 |
1/400 (0.25%)
|
1 |
LYMPHOEDEMA |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
0/400 (0.00%)
|
0 |
ORTHOSTATIC HYPOTENSION |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
1/400 (0.25%)
|
1 |
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE |
0/394 (0.00%)
|
0 |
0/393 (0.00%)
|
0 |
1/400 (0.25%)
|
1 |
PERIPHERAL ARTERY THROMBOSIS |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
0/400 (0.00%)
|
0 |
PERIPHERAL ISCHAEMIA |
0/394 (0.00%)
|
0 |
1/393 (0.25%)
|
1 |
1/400 (0.25%)
|
1 |
PERIPHERAL VASCULAR DISORDER |
1/394 (0.25%)
|
1 |
0/393 (0.00%)
|
0 |
0/400 (0.00%)
|
0 |
THROMBOSIS |
1/394 (0.25%)
|
1 |
2/393 (0.51%)
|
2 |
1/400 (0.25%)
|
1 |
VENOUS THROMBOSIS LIMB |
0/394 (0.00%)
|
0 |
0/393 (0.00%)
|
0 |
1/400 (0.25%)
|
1 |
Term from vocabulary, MedDRA version 23.1
Indicates events were collected by systematic assessment
|
|
Frequency Threshold for Reporting Other Adverse Events
|
5%
|
|
Arm C (Bev+CP)
|
Arm B (Atezo+Bev+CP)
|
Arm A (Atezo+CP)
|
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Total |
381/394 (96.70%)
|
|
375/393 (95.42%)
|
|
385/400 (96.25%)
|
|
Blood and lymphatic system disorders |
|
|
|
ANAEMIA |
104/394 (26.40%)
|
124 |
116/393 (29.52%)
|
134 |
146/400 (36.50%)
|
183 |
LEUKOPENIA |
14/394 (3.55%)
|
17 |
14/393 (3.56%)
|
20 |
20/400 (5.00%)
|
35 |
NEUTROPENIA |
70/394 (17.77%)
|
107 |
72/393 (18.32%)
|
111 |
60/400 (15.00%)
|
85 |
THROMBOCYTOPENIA |
45/394 (11.42%)
|
64 |
53/393 (13.49%)
|
74 |
49/400 (12.25%)
|
78 |
Endocrine disorders |
|
|
|
HYPOTHYROIDISM |
13/394 (3.30%)
|
13 |
50/393 (12.72%)
|
56 |
33/400 (8.25%)
|
40 |
Gastrointestinal disorders |
|
|
|
ABDOMINAL PAIN |
20/394 (5.08%)
|
24 |
36/393 (9.16%)
|
48 |
29/400 (7.25%)
|
36 |
CONSTIPATION |
92/394 (23.35%)
|
115 |
122/393 (31.04%)
|
151 |
103/400 (25.75%)
|
128 |
DIARRHOEA |
98/394 (24.87%)
|
133 |
125/393 (31.81%)
|
221 |
82/400 (20.50%)
|
137 |
DRY MOUTH |
6/394 (1.52%)
|
6 |
20/393 (5.09%)
|
22 |
13/400 (3.25%)
|
16 |
GASTROOESOPHAGEAL REFLUX DISEASE |
9/394 (2.28%)
|
11 |
20/393 (5.09%)
|
20 |
11/400 (2.75%)
|
13 |
NAUSEA |
124/394 (31.47%)
|
177 |
149/393 (37.91%)
|
223 |
130/400 (32.50%)
|
210 |
STOMATITIS |
24/394 (6.09%)
|
30 |
54/393 (13.74%)
|
73 |
23/400 (5.75%)
|
27 |
VOMITING |
67/394 (17.01%)
|
105 |
71/393 (18.07%)
|
99 |
69/400 (17.25%)
|
92 |
General disorders |
|
|
|
ASTHENIA |
80/394 (20.30%)
|
107 |
84/393 (21.37%)
|
143 |
76/400 (19.00%)
|
127 |
CHEST PAIN |
28/394 (7.11%)
|
32 |
35/393 (8.91%)
|
37 |
38/400 (9.50%)
|
44 |
FATIGUE |
107/394 (27.16%)
|
125 |
137/393 (34.86%)
|
157 |
111/400 (27.75%)
|
129 |
MALAISE |
11/394 (2.79%)
|
13 |
27/393 (6.87%)
|
43 |
20/400 (5.00%)
|
27 |
MUCOSAL INFLAMMATION |
24/394 (6.09%)
|
27 |
38/393 (9.67%)
|
42 |
10/400 (2.50%)
|
10 |
OEDEMA PERIPHERAL |
19/394 (4.82%)
|
20 |
35/393 (8.91%)
|
42 |
29/400 (7.25%)
|
33 |
PAIN |
17/394 (4.31%)
|
17 |
26/393 (6.62%)
|
31 |
22/400 (5.50%)
|
23 |
PYREXIA |
34/394 (8.63%)
|
44 |
67/393 (17.05%)
|
88 |
53/400 (13.25%)
|
66 |
Infections and infestations |
|
|
|
BRONCHITIS |
16/394 (4.06%)
|
17 |
28/393 (7.12%)
|
37 |
15/400 (3.75%)
|
16 |
NASOPHARYNGITIS |
17/394 (4.31%)
|
18 |
27/393 (6.87%)
|
34 |
31/400 (7.75%)
|
50 |
PNEUMONIA |
15/394 (3.81%)
|
17 |
19/393 (4.83%)
|
22 |
21/400 (5.25%)
|
23 |
UPPER RESPIRATORY TRACT INFECTION |
16/394 (4.06%)
|
20 |
37/393 (9.41%)
|
56 |
24/400 (6.00%)
|
43 |
URINARY TRACT INFECTION |
28/394 (7.11%)
|
37 |
35/393 (8.91%)
|
57 |
37/400 (9.25%)
|
51 |
Investigations |
|
|
|
ALANINE AMINOTRANSFERASE INCREASED |
20/394 (5.08%)
|
24 |
30/393 (7.63%)
|
45 |
22/400 (5.50%)
|
26 |
ASPARTATE AMINOTRANSFERASE INCREASED |
18/394 (4.57%)
|
19 |
30/393 (7.63%)
|
48 |
22/400 (5.50%)
|
29 |
NEUTROPHIL COUNT DECREASED |
34/394 (8.63%)
|
72 |
49/393 (12.47%)
|
87 |
33/400 (8.25%)
|
64 |
PLATELET COUNT DECREASED |
44/394 (11.17%)
|
76 |
57/393 (14.50%)
|
84 |
41/400 (10.25%)
|
59 |
WEIGHT DECREASED |
42/394 (10.66%)
|
46 |
52/393 (13.23%)
|
56 |
29/400 (7.25%)
|
32 |
WHITE BLOOD CELL COUNT DECREASED |
20/394 (5.08%)
|
39 |
26/393 (6.62%)
|
42 |
17/400 (4.25%)
|
27 |
Metabolism and nutrition disorders |
|
|
|
DECREASED APPETITE |
86/394 (21.83%)
|
102 |
119/393 (30.28%)
|
157 |
100/400 (25.00%)
|
129 |
DEHYDRATION |
15/394 (3.81%)
|
16 |
33/393 (8.40%)
|
42 |
7/400 (1.75%)
|
7 |
HYPOKALAEMIA |
16/394 (4.06%)
|
18 |
36/393 (9.16%)
|
47 |
24/400 (6.00%)
|
30 |
HYPOMAGNESAEMIA |
25/394 (6.35%)
|
29 |
55/393 (13.99%)
|
76 |
38/400 (9.50%)
|
49 |
HYPONATRAEMIA |
17/394 (4.31%)
|
20 |
23/393 (5.85%)
|
32 |
13/400 (3.25%)
|
14 |
Musculoskeletal and connective tissue disorders |
|
|
|
ARTHRALGIA |
102/394 (25.89%)
|
155 |
130/393 (33.08%)
|
227 |
105/400 (26.25%)
|
175 |
BACK PAIN |
43/394 (10.91%)
|
50 |
57/393 (14.50%)
|
67 |
51/400 (12.75%)
|
70 |
BONE PAIN |
19/394 (4.82%)
|
19 |
23/393 (5.85%)
|
33 |
16/400 (4.00%)
|
18 |
MUSCLE SPASMS |
7/394 (1.78%)
|
8 |
20/393 (5.09%)
|
24 |
10/400 (2.50%)
|
10 |
MYALGIA |
53/394 (13.45%)
|
81 |
69/393 (17.56%)
|
118 |
67/400 (16.75%)
|
104 |
PAIN IN EXTREMITY |
32/394 (8.12%)
|
43 |
50/393 (12.72%)
|
63 |
45/400 (11.25%)
|
52 |
Nervous system disorders |
|
|
|
DIZZINESS |
26/394 (6.60%)
|
31 |
27/393 (6.87%)
|
34 |
28/400 (7.00%)
|
39 |
DYSGEUSIA |
19/394 (4.82%)
|
24 |
24/393 (6.11%)
|
27 |
15/400 (3.75%)
|
16 |
HEADACHE |
53/394 (13.45%)
|
65 |
70/393 (17.81%)
|
87 |
41/400 (10.25%)
|
49 |
NEUROPATHY PERIPHERAL |
67/394 (17.01%)
|
77 |
92/393 (23.41%)
|
105 |
104/400 (26.00%)
|
117 |
PARAESTHESIA |
44/394 (11.17%)
|
50 |
53/393 (13.49%)
|
59 |
37/400 (9.25%)
|
42 |
PERIPHERAL SENSORY NEUROPATHY |
54/394 (13.71%)
|
59 |
65/393 (16.54%)
|
73 |
58/400 (14.50%)
|
65 |
Psychiatric disorders |
|
|
|
ANXIETY |
22/394 (5.58%)
|
23 |
31/393 (7.89%)
|
31 |
23/400 (5.75%)
|
23 |
DEPRESSION |
13/394 (3.30%)
|
13 |
25/393 (6.36%)
|
26 |
15/400 (3.75%)
|
16 |
INSOMNIA |
38/394 (9.64%)
|
41 |
42/393 (10.69%)
|
43 |
50/400 (12.50%)
|
56 |
Renal and urinary disorders |
|
|
|
PROTEINURIA |
63/394 (15.99%)
|
81 |
80/393 (20.36%)
|
128 |
9/400 (2.25%)
|
13 |
Respiratory, thoracic and mediastinal disorders |
|
|
|
COUGH |
77/394 (19.54%)
|
94 |
86/393 (21.88%)
|
107 |
82/400 (20.50%)
|
99 |
DYSPHONIA |
18/394 (4.57%)
|
19 |
27/393 (6.87%)
|
27 |
11/400 (2.75%)
|
12 |
DYSPNOEA |
60/394 (15.23%)
|
66 |
67/393 (17.05%)
|
81 |
86/400 (21.50%)
|
107 |
EPISTAXIS |
86/394 (21.83%)
|
108 |
67/393 (17.05%)
|
89 |
17/400 (4.25%)
|
22 |
HAEMOPTYSIS |
18/394 (4.57%)
|
21 |
21/393 (5.34%)
|
24 |
16/400 (4.00%)
|
27 |
OROPHARYNGEAL PAIN |
10/394 (2.54%)
|
10 |
22/393 (5.60%)
|
25 |
9/400 (2.25%)
|
10 |
Skin and subcutaneous tissue disorders |
|
|
|
ALOPECIA |
180/394 (45.69%)
|
183 |
188/393 (47.84%)
|
195 |
180/400 (45.00%)
|
182 |
DRY SKIN |
9/394 (2.28%)
|
9 |
29/393 (7.38%)
|
31 |
24/400 (6.00%)
|
28 |
PRURITUS |
25/394 (6.35%)
|
29 |
58/393 (14.76%)
|
76 |
52/400 (13.00%)
|
72 |
RASH |
28/394 (7.11%)
|
34 |
72/393 (18.32%)
|
92 |
71/400 (17.75%)
|
94 |
Vascular disorders |
|
|
|
HYPERTENSION |
87/394 (22.08%)
|
102 |
104/393 (26.46%)
|
149 |
16/400 (4.00%)
|
16 |
Term from vocabulary, MedDRA version 23.1
Indicates events were collected by systematic assessment
|