arequipa, 09 de agosto del 2017

dr. salomn zavala sarrio

presidente del comit de tica prisma

presente.-
referencia: protocolo mk3475-119 - safety reports
por medio de la presente me es grato saludarlo y a la vez comunicarle que, cumpliendo con las
buenas prcticas clnicas se le hace entrega de una copia de los reportes de seguridad
relacionados a la medicacin del estudio, pembrolizumab, que ocurrieron desde 03.04.2017 al
14.04.2017 la cual es utilizada en el protocolo de la referencia.
n de reporte fecha de pas de tipo de
evento
mcn reporte procedencia reporte
[Sinusitis]
Erythroblastopenia [Aplasia pure red cell]
Pancytopenia [Pancytopenia]
1609FRA013501 01-jun-2017 FRANCE followup:9
Myelodysplasia [Myelodysplastic syndrome]
Anemia [Anaemia]
Diarrhea [Diarrhoea]
1701CHN010283 01-jun-2017 CHINA followup:13 [Pneumonia]

1701BRA008225 01-jun-2017 BRAZIL followup:7 [Impaired gastric emptying]

[Neutrophil count decreased]

1606AUS000988 01-jun-2017 AUSTRALIA followup:13
worsening pleural effusion [Pleural effusion]

1704KOR004181 01-jun-2017 KOREA, REPUBLIC OF followup:2 [Oesophagitis]

[Oesophageal ulcer]
1705USA007599 01-jun-2017 UNITED STATES initial
Non-cardiac chest pain [Non-cardiac chest pain]
[Acute kidney injury]
1705AUS008871 01-jun-2017 AUSTRALIA followup:1
acute pancreatitis [Pancreatitis acute]
[Hydrothorax]
1705RUS006992 01-jun-2017 RUSSIAN FEDERATION followup:3
Atelectasis right G2 [Atelectasis]
[Right ventricular failure]
1705USA015304 01-jun-2017 UNITED STATES initial
shortness of breath [Dyspnoea]
[Pneumonia]
1705USA014133 01-jun-2017 UNITED STATES initial Congestive heart failure [Cardiac failure congestive]
right lung pneumonia [Pneumonia]
II 01-jun-2017

1705ISR011415 01-jun-2017 ISRAEL followup:2 [Blood creatinine increased]

[Febrile neutropenia]
1704ITA003431 01-jun-2017 ITALY followup:1 Thrombocytopenia [Thrombocytopenia]
Anemia [Anaemia]
[Dehydration]
hypotension [Hypotension]
dehydration [Dehydration]
1703USA013419 01-jun-2017 UNITED STATES followup:1 lung infection (pneumonia) [Pneumonia]
hypokalemia [Hypokalaemia]
gastrointestinal disorders-other, excessive salivation [Salivary
hypersecretion]
[Decreased appetite]
1704JPN012284 01-jun-2017 JAPAN followup:6
hypopituitarism [Hypopituitarism]
[Hypoxia]
1705USA013896 01-jun-2017 UNITED STATES initial
Pneumonitis [Pneumonitis]

1705TUR015371 01-jun-2017 TURKEY initial [Pleural effusion]

1705DNK011316 01-jun-2017 DENMARK followup:2 [Blood bilirubin increased]

1702USA009811 01-jun-2017 UNITED STATES followup:1 [Small intestine ulcer]

1705FRA004210 01-jun-2017 FRANCE followup:2 [Hepatocellular injury]

Pgina 1 de 18
 1606FRA003207 01-jun-2017 FRANCE followup:6 [Vomiting]

III 01-jun-2017

[Dyspnoea]
1705DNK007083 01-jun-2017 DENMARK followup:3
fever [Pyrexia]

1703JPN007189 01-jun-2017 JAPAN followup:1 [Pneumothorax]

1705TUR003433 01-jun-2017 TURKEY followup:2 [Lung infection]

1702CHE004812 01-jun-2017 SWITZERLAND followup:4 [Urinary tract infection]

[Cardiomyopathy]
1705BRA015061 01-jun-2017 BRAZIL followup:1
arrhythmia [Arrhythmia]
[Tachycardia]
Flushing [Flushing]
1704USA005308 01-jun-2017 UNITED STATES followup:2
Decreased PO intake [Hypophagia]
Fatigue [Fatigue]
[Mucosal inflammation]
1705BRA015407 01-jun-2017 BRAZIL initial fever [Pyrexia]

1705USA010733 01-jun-2017 UNITED STATES followup:1 [Aphasia]

1704TUR012861 01-jun-2017 TURKEY followup:11 [Hepatotoxicity]

1703JPN004674 01-jun-2017 JAPAN followup:5 [Adrenal insufficiency]

IV 01-jun-2017
[Laryngeal stenosis]
1705JPN007572 01-jun-2017 JAPAN followup:7 Febrile neutropenia [Febrile neutropenia]
[Lung infection]
1504USA009886 01-jun-2017 UNITED STATES followup:1 pneumonia [Pneumonia]
Pneumonitis [Pneumonitis]
1703NZL010870 01-jun-2017 NEW ZEALAND followup:4 [Chest pain]

[Renal impairment]
1703NLD002060 01-jun-2017 NETHERLANDS followup:12
decreased renal function [Renal impairment]

1610AUS016611 01-jun-2017 AUSTRALIA followup:6 [Pyrexia]

1607PHL011059 01-jun-2017 PHILIPPINES followup:3 [Anaemia]

1705ISR015421 01-jun-2017 ISRAEL initial [Hepatic enzyme increased]

1704FRA002427 01-jun-2017 FRANCE followup:4 [Autoimmune colitis]

[Neuritis]
1704DEU004539 01-jun-2017 GERMANY followup:4 worsening of muscle weakness [Muscular weakness]

I 02-jun-2017
[Colitis]
1603CZE001692 02-jun-2017 CZECH REPUBLIC followup:3 mucositis in the oral cavity [Stomatitis]
renal failure [Renal failure]
1606TUR013046 02-jun-2017 TURKEY followup:9 [Pulmonary embolism]
[Decreased appetite]
1704HKG004741 02-jun-2017 HONG KONG followup:4 Hypophysitis [Hypophysitis]
Anemia [Anaemia]
1705TUR015371 02-jun-2017 TURKEY followup:1 [Pleural effusion]

1705USA015983 02-jun-2017 UNITED STATES initial [Acidosis]

1608BRA015042 02-jun-2017 BRAZIL followup:11 [Sepsis]

[Weight decreased]
Anorexia [Decreased appetite]
Nausea [Nausea]
Fatigue [Fatigue]
1703USA007251 02-jun-2017 UNITED STATES followup:4 Shortness of breath [Dyspnoea]
Constipation [Constipation]
Diarrhea [Diarrhoea]
Back pain [Back pain]

Pgina 2 de 18
 [Laryngeal oedema]
1704HUN004782 02-jun-2017 HUNGARY followup:6 abscess [Abscess]

1705PHL011546 02-jun-2017 PHILIPPINES followup:1 [Tumour haemorrhage]

1703FRA009682 02-jun-2017 FRANCE followup:6 [Lung infection]

II 02-jun-2017
[Cardiac failure]
1705USA015304 02-jun-2017 UNITED STATES followup:1 shortness of breath [Dyspnoea]
[Sepsis]
TAIWAN, PROVINCE OF
1501TWN008804 02-jun-2017 CHINA followup:11 acute renal failure [Acute kidney injury]
jaundice [Jaundice]
[Adrenal insufficiency]
1606USA005236 02-jun-2017 UNITED STATES followup:17 pericarditis [Pericarditis]
[Platelet count decreased]
anemia [Anaemia]
nausea [Nausea]
vomiting [Vomiting]
1705USA005910 02-jun-2017 UNITED STATES followup:2 anorexia [Decreased appetite]
mechanical fall [Fall]
subdural hematoma (intracranical hemorrhage) [Subdural
haematoma]
[Cardiac failure congestive]
1705USA014133 02-jun-2017 UNITED STATES followup:1
right lung pneumonia [Pneumonia]

1703FIN009729 02-jun-2017 FINLAND followup:10 [Pneumonia]

1704TUR012305 02-jun-2017 TURKEY followup:2 [Pneumonia]

1705FRA008163 02-jun-2017 FRANCE followup:4 [Peritonitis]

1703USA007587 02-jun-2017 UNITED STATES followup:1 [Lung infiltration]

1702HKG002458 02-jun-2017 HONG KONG followup:9 [Acute myocardial infarction]

III 02-jun-2017

1701BEL001123 02-jun-2017 BELGIUM followup:10 [Arthritis]

1705BEL014741 02-jun-2017 BELGIUM initial [Bronchitis]

1701POL013721 02-jun-2017 POLAND followup:5 [Neutropenia]

1704POL001398 02-jun-2017 POLAND followup:3 [Anaemia]

1705DNK002390 02-jun-2017 DENMARK followup:5 [Peripheral motor neuropathy]

1704USA000086 02-jun-2017 UNITED STATES followup:8 [Brain oedema]

1701CAN009678 02-jun-2017 CANADA followup:16 [Acute respiratory distress syndrome]

[Immune thrombocytopenic purpura]

1704USA000804 02-jun-2017 UNITED STATES followup:3 Gastric Hemorrhage [Gastric haemorrhage]

1705FRA004348 02-jun-2017 FRANCE followup:2 [Hepatocellular injury]

1705TUR003433 02-jun-2017 TURKEY followup:3 [Lung infection]

IV 02-jun-2017
[Hyperglycaemia]
1706USA000441 02-jun-2017 UNITED STATES initial Hyponatremia [Hyponatraemia]
[Jaundice cholestatic]
hemorrhagic septic shock [Septic shock]
Upper gastrointestinal bleeding [Upper gastrointestinal
1609FRA008338 02-jun-2017 FRANCE followup:15
haemorrhage]
cytolysis [Cell death]
ascitis [Ascites]
1703USA012819 02-jun-2017 UNITED STATES followup:4 [Polymyalgia rheumatica]

1610DEU000613 02-jun-2017 GERMANY followup:9 [Epilepsy]

[Pneumonia]
1701MEX012708 02-jun-2017 MEXICO followup:15 mucositis oral [Stomatitis]
Neutrophil decreased [Neutrophil count decreased]
Pgina 3 de 18
 White blood cells decreased [White blood cell count
decreased]
dehydration [Dehydration]
[Cardiac failure]
1706USA000504 02-jun-2017 UNITED STATES initial Partial Large Bowel Obstruction [Large intestinal obstruction]

1704USA014674 02-jun-2017 UNITED STATES followup:5 [Acute respiratory failure]

[Immune system disorder]
1701USA004870 02-jun-2017 UNITED STATES followup:22 encephalitis [Encephalitis]
Hypercalcemia [Hypercalcaemia]

I 05jun-2017
[Febrile neutropenia]
1602PER006636 05jun-2017 PERU followup:14 Neutropenia grade IV [Neutropenia]
[Adrenal insufficiency]
1608JPN001781 05jun-2017 JAPAN followup:23 Interstitial pneumonia [Interstitial lung disease]
Hypothyroidism [Hypothyroidism]
1704USA004681 05jun-2017 UNITED STATES followup:6 [Cardiac failure]

1705KOR015314 05jun-2017 KOREA, REPUBLIC OF initial Encephalitis]

1703PRT011498 05jun-2017 PORTUGAL followup:2 [Febrile neutropenia]

[Neutropenia]
1612TUR010745 05jun-2017 TURKEY followup:12 candida albicans infection [Candida infection]
flu [Influenza]
1705DNK011316 05jun-2017 DENMARK followup:3 [Blood bilirubin increased]
Pleural effusion]
multiple occurrence of decreased platelets [Platelet count
1512USA000512 05jun-2017 UNITED STATES followup:17 decreased]
multiple occurrence of decreased lymphocytes [Lymphocyte
count decreased]
1705PRT003396 05jun-2017 PORTUGAL followup:1 [Haemorrhage]

Acute kidney injury]

1701POL001460 05jun-2017 POLAND followup:10 hematuria [Haematuria]
Malignant melanoma]
aphasia [Aphasia]
Depressed level of consciousness [Depressed level of
1703CAN007014 05jun-2017 CANADA initial consciousness]
Muscle weakness right-sided [Hemiparesis]
Dysarthria [Dysarthria]
II 05jun-2017

1706USA000539 05jun-2017 UNITED STATES followup:1 [Hyperglycaemia]

[Immune system disorder]
1701USA004870 05jun-2017 UNITED STATES followup:23 encephalitis [Encephalitis]
Hypercalcemia [Hypercalcaemia]
[Platelet count decreased]
1704CAN005309 05jun-2017 CANADA followup:11
decreased platelet count [Platelet count decreased]
[Thrombocytopenia]
1704USA002450 05jun-2017 UNITED STATES followup:1 vomiting [Vomiting]
anemia [Anaemia]
[Oesophageal ulcer]
1705USA007599 05jun-2017 UNITED STATES followup:1 Non-cardiac chest pain [Non-cardiac chest pain]

1706SWE000519 05jun-2017 SWEDEN initial [Neuropathy peripheral]

[Chronic obstructive pulmonary disease]
1608USA003192 05jun-2017 UNITED STATES followup:11 Thromboembolic event (pulmonary embolism) [Pulmonary
embolism]
[Type 2 diabetes mellitus]
1609CAN009194 05jun-2017 CANADA followup:18 diabetes type 2 [Type 2 diabetes mellitus]
[Laryngeal oedema]
1605USA005123 05jun-2017 UNITED STATES followup:15
Sepsis [Sepsis]
[Mucosal inflammation]
1705BRA015407 05jun-2017 BRAZIL followup:1 fever [Pyrexia]
Tumour haemorrhage]
1701TUR004794 05jun-2017 TURKEY followup:17 Patient's PEG hose out [Complication associated with device]
[Drug-induced liver injury]
Hyperbilirubinemia [Hyperbilirubinaemia]
1705USA011535 05jun-2017 UNITED STATES followup:2 fulminant liver failure [Acute hepatic failure]
acute respiratory failure [Acute respiratory failure]
acute renal failure [Acute kidney injury]
Pgina 4 de 18
III 05jun-2017
[Cardiomyopathy]
1705BRA015061 05jun-2017 BRAZIL followup:2 arrhythmia [Arrhythmia]
[Myocarditis]
gastrointestinal hemorrhage [Small intestinal haemorrhage]
1507USA004931 05jun-2017 UNITED STATES followup:7 hyperglycemia [Hyperglycaemia]
arrhythmia [Ventricular arrhythmia]
1705JPN012588 05jun-2017 JAPAN followup:1 [Hyperglycaemia]

1705CHE004004 05jun-2017 SWITZERLAND followup:1 [Dermatitis infected]

1705CZE015239 05jun-2017 CZECH REPUBLIC followup:1 [IIIrd nerve disorder]

1705CHN009357 05jun-2017 CHINA followup:1 [Anaemia]

[Anaemia]
1701CHN011993 05jun-2017 CHINA followup:21 platelet count decreased [Platelet count decreased]
platelet count decreased [Platelet count decreased]
TAIWAN, PROVINCE OF
1705TWN006966 05jun-2017 CHINA followup:2 [Blood bilirubin increased]

1705CHN014116 05jun-2017 CHINA followup:1 [Pneumonia]

1704CHN007173 05jun-2017 CHINA followup:12 [Diabetes mellitus]

1704USA002589 05jun-2017 UNITED STATES followup:2 [Death]

1701AUS014386 05jun-2017 AUSTRALIA followup:7 [Pneumatosis intestinalis]

IV 05jun-2017

1704CHL003273 05jun-2017 CHILE followup:5 [Pneumonia]

[Acute kidney injury]
1609USA008149 05jun-2017 UNITED STATES followup:12 Increased AST [Aspartate aminotransferase increased]
Increased ALT [Alanine aminotransferase increased]
1610USA012420 05jun-2017 UNITED STATES followup:12 [Cardiac tamponade]
[General physical condition abnormal]
1605FRA000026 05jun-2017 FRANCE followup:8 Septicemia grade 3 [Sepsis]
hypokalemia grade 4 [Hypokalaemia]
1705MYS015219 05jun-2017 MALAYSIA initial [[Inappropriate antidiuretic hormone secretion]]

[Laryngeal stenosis]
1705JPN007572 05jun-2017 JAPAN followup:8 Febrile neutropenia [Febrile neutropenia]

1706USA001512 05jun-2017 UNITED STATES initial [Intestinal obstruction]

1702HUN009462 05jun-2017 HUNGARY followup:9 [Thrombocytopenia]

1702MEX011300 05jun-2017 MEXICO followup:1 [Death]

Febrile neutropenia]
1704AUS006650 05jun-2017 AUSTRALIA followup:4 anaemia [Anaemia]
[Pancytopenia]
1608ISR001315 05jun-2017 ISRAEL followup:8 Infusion related reaction [Infusion related reaction]
[Neuralgia]
1703AUS003926 05jun-2017 AUSTRALIA followup:9
Neuralgia [Neuralgia]
I 06jun-2017
[Colitis]
1603CZE001692 06jun-2017 CZECH REPUBLIC followup:4 mucositis in the oral cavity [Stomatitis]
renal failure [Renal failure]
[Cardiac failure]
1704CZE009943 06jun-2017 CZECH REPUBLIC followup:8 Deterioration of the overall condition [General physical health
deterioration]
1706CHN001835 06jun-2017 CHINA initial [Respiratory failure]

1602JPN011528 06jun-2017 JAPAN followup:8 [Febrile neutropenia]

1609MEX010327 06jun-2017 MEXICO followup:12 [Gastrointestinal toxicity]

1705TUR005646 06jun-2017 TURKEY followup:3 [Neutrophil count decreased]

Pgina 5 de 18
 1705USA005535 06jun-2017 UNITED STATES followup:1 [Vomiting]

1612TUR009473 06jun-2017 TURKEY followup:5 [Pleural effusion]

1703BRA011508 06jun-2017 BRAZIL followup:4 [Febrile neutropenia]

1612MEX002616 06jun-2017 MEXICO followup:7 Angioedema]

[Cerebral haemorrhage]
1706USA001913 06jun-2017 UNITED STATES initial Low platelets [Platelet count decreased]

1611CHN000232 06jun-2017 CHINA followup:11 [Pulmonary embolism]

II 06jun-2017
[Malaise]
1605JPN000797 06jun-2017 JAPAN followup:17 Anorexia [Decreased appetite]
depression [Depression]
1706USA000494 06jun-2017 UNITED STATES initial [Arthritis]

1612DEU009954 06jun-2017 GERMANY followup:6 [Lipase increased]

[Cardiac failure congestive]
1705USA014133 06jun-2017 UNITED STATES followup:2 pneumonitis [Pneumonitis]
right lung pneumonia [Pneumonia]
1705CHN014116 06jun-2017 CHINA followup:2 [Pneumonia]

1702HUN008114 06jun-2017 HUNGARY followup:11 [Hypokalaemia]

[Pneumonia]
1608PRT001317 06jun-2017 PORTUGAL followup:15 febrile neutropenia [Febrile neutropenia]
[Vomiting]
nausea [Nausea]
1702DNK003511 06jun-2017 DENMARK followup:9 Elevated ALAT [Alanine aminotransferase increased]
Fever [Pyrexia]
1704DEU011257 06jun-2017 GERMANY followup:2 [Febrile neutropenia]

1705TUR003433 06jun-2017 TURKEY followup:4 [Lung infection]

1702GBR010473 06jun-2017 UNITED KINGDOM followup:9 [Lower respiratory tract infection]

[Pneumonia]
1510DEU006434 06jun-2017 GERMANY followup:22 Malignant neoplasm Progression [Malignant neoplasm
progression]
III 06jun-2017
[Cardiac arrest]
lung infection [Lung infection]
lung infection [Lung infection]
1703CAN000541 06jun-2017 CANADA followup:2
pleural effusion [Pleural effusion]
nausea [Nausea]
vomiting [Vomiting]
[Dehydration]
hypotension [Hypotension]
dehydration [Dehydration]
1703USA013419 06jun-2017 UNITED STATES followup:2 lung infection (pneumonia) [Pneumonia]
hypokalemia [Hypokalaemia]
gastrointestinal disorders-other, excessive salivation [Salivary
hypersecretion]
[Adrenal insufficiency]
1704ESP007186 06jun-2017 SPAIN followup:6 Hypophysitis [Hypophysitis]
[Hepatotoxicity]
1704TUR008907 06jun-2017 TURKEY followup:11 Hypercalcemia [Hypercalcaemia]

1703USA009090 06jun-2017 UNITED STATES followup:2 [White blood cell count decreased]

1701FRA001751 06jun-2017 FRANCE followup:3 [Hepatocellular carcinoma]

TAIWAN, PROVINCE OF
1705TWN003438 06jun-2017 CHINA followup:1 [Glomerulonephritis membranous]
[Fanconi syndrome]
Sepsis [Sepsis]
1704ITA000756 06jun-2017 ITALY followup:1 Adrenal insufficiency [Adrenal insufficiency]
Colitis [Colitis]
[Adverse event]
1701USA009044 06jun-2017 UNITED STATES followup:2 Hypoglycemia [Hypoglycaemia]

Pgina 6 de 18
 [Hydrothorax]
1705RUS006992 06jun-2017 RUSSIAN FEDERATION followup:4 Atelectasis right G2 [Atelectasis]
[Hydrothorax]
1704HKG004741 06jun-2017 HONG KONG followup:5 Atelectasis right G2 [Atelectasis]
[Hypophysitis]
TAIWAN, PROVINCE OF
1703TWN014089 06jun-2017 CHINA followup:3 Anemia [Anaemia]
Anorexia [Decreased appetite]
IV

1612NOR012887 06jun-2017 [NORWAY] followup:9 [Sarcoidosis]

[Thrombocytopenia]
hepatitis [Hepatitis]
1705CAN002463 06jun-2017 CANADA initial fever [Pyrexia]
platelet count decreased [Platelet count decreased]
[Anaemia]
1602USA010064 06jun-2017 UNITED STATES followup:8
cellulitis of abdominal wall [Cellulitis]

1704AUS011270 06jun-2017 AUSTRALIA followup:4 [Necrotising scleritis]

1706SWE000519 06jun-2017 SWEDEN followup:1 [Neuropathy peripheral]

[Blood creatinine increased]

1704ESP011472 06jun-2017 SPAIN followup:10 Anemia due to treatment [Anaemia]

1705GTM000046 06jun-2017 GUATEMALA followup:4 [Lung abscess]

[Acute kidney injury]
1705AUS008871 06jun-2017 AUSTRALIA followup:2 acute pancreatitis [Pancreatitis acute]
ataxia [Ataxia]
V 06jun-2017
[Immune thrombocytopenic purpura]
anemia [Anaemia]
1704USA000804 06jun-2017 UNITED STATES initial esophageal hemorrhage [Oesophageal haemorrhage]
platelet count decreased [Platelet count decreased]
1703NZL010870 06jun-2017 NEW ZEALAND followup:5 [Chest pain]

1703NLD009501 06jun-2017 NETHERLANDS followup:1 [Headache]

1704USA014674 06jun-2017 UNITED STATES followup:6 [Pneumonia]

[Urticaria]
1610FRA013349 06jun-2017 FRANCE followup:9
obstructive pyelonephritis [Pyelonephritis]

1705CHN009357 06jun-2017 CHINA followup:2 [Anaemia]

[Back pain]
1706USA001854 06jun-2017 UNITED STATES initial ELEVATED LIVER ENZYME LEVELS [Hepatic enzyme
increased]
1706JPN001805 06jun-2017 JAPAN initial [Blood creatine phosphokinase increased]

1701SWE011967 07jun-2017 SWEDEN followup:10 [Dermatitis exfoliative]

1702GBR002495 07jun-2017 UNITED KINGDOM followup:12 [Blood calcium increased]

1608MEX010596 07jun-2017 MEXICO followup:16 [Acute kidney injury]

[Malaise]
1701TUR004418 07jun-2017 TURKEY followup:9 fatigue [Fatigue]
abdominal pain [Abdominal pain]
1611ISR007474 07jun-2017 ISRAEL followup:19 [Osteomyelitis]

[Hyponatraemia]
1609BRA010301 07jun-2017 BRAZIL followup:11 renal insufficiency [Renal failure]

1701TUR001065 07jun-2017 TURKEY followup:9 [Lung infection]

1704CHN013063 07jun-2017 CHINA followup:7 [Anaemia]

[Renal impairment]
Acute kidney insult [Acute kidney injury]
Pleural effusions [Pleural effusion]
1607USA007733 07jun-2017 UNITED STATES followup:7
Scrotal edema [Scrotal oedema]
Urinary tract obstruction [Urinary tract obstruction]
Scrotal cellulitis [Cellulitis of male external genital organ]

Pgina 7 de 18
 SOB (shortness of breath) [Dyspnoea]
Edema [Oedema]
[Hyperglycaemia]
1705USA005491 07jun-2017 UNITED STATES followup:1
dyspnea, possible infection [Dyspnoea]
TAIWAN, PROVINCE OF
1611TWN005062 07jun-2017 CHINA followup:9 [Febrile neutropenia]

[Asthenia]
1705FRA000455 07jun-2017 FRANCE followup:2
rhabdomyolysis [Rhabdomyolysis]

II 07jun-2017

1705MYS015219 07jun-2017 MALAYSIA followup:1 [Inappropriate antidiuretic hormone secretion]

1706USA001421 07jun-2017 UNITED STATES initial [Infection]

1705JPN012588 07jun-2017 JAPAN followup:2 [Hyperglycaemia]

[Platelet count decreased]

1704CAN005309 07jun-2017 CANADA followup:12
decreased platelet count [Platelet count decreased]

1612SRB009264 07jun-2017 SERBIA Followup:1 [Metastases to central nervous system]

[Hypercalcaemia]
Confusion and disorientation [Confusional state]
1706MEX000313 07jun-2017 MEXICO initial
Confusion and disorientation [Disorientation]
Hypomagnesemia [Hypomagnesaemia]
[Pancytopenia]
1608ISR001315 07jun-2017 ISRAEL followup:9 Infusion related reaction [Infusion related reaction]

1701USA006171 07jun-2017 UNITED STATES followup:6 [Pharyngeal haemorrhage]

[Pyrexia]
1703USA012690 07jun-2017 UNITED STATES followup:6
interstitial nephritis [Tubulointerstitial nephritis]
[Stomatitis]
TAIWAN, PROVINCE OF febrile neutropenia [Febrile neutropenia]
1701TWN008871 07jun-2017 CHINA followup:15
escherichia coli bacteremia [Escherichia bacteraemia]
left facial swelling [Swelling face]
1705CHL008120 07jun-2017 CHILE followup:2 [Hyperglycaemia]
[Colitis]
1705USA006722 07jun-2017 UNITED STATES initial Intractable nausea [Nausea]
Intractable vomiting [Vomiting]
III 07jun-2017
[Laryngeal stenosis]
1705JPN007572 07jun-2017 JAPAN followup:9
Febrile neutropenia [Febrile neutropenia]
[Sepsis]
1702FRA009587 07jun-2017 FRANCE followup:10
Psoriasis reactivation [Psoriasis]
[Hypotension]
adrenal insufficiency [Adrenal insufficiency]
Adrenal insufficiency (worsening) [Adrenal insufficiency]
adrenal insufficiency [Adrenal insufficiency]
weight loss [Weight decreased]
1703USA002165 07jun-2017 UNITED STATES followup:3
fatigue [Fatigue]
right shoulder pain [Musculoskeletal pain]
anemia [Anaemia]
adrenal insufficiency [Adrenal insufficiency]
hypotension [Hypotension]
1704CHL003273 07jun-2017 CHILE followup:6 [Pneumonia]

[Pleural effusion]
1701PHL010538 07jun-2017 PHILIPPINES followup:5
Pneumonia in the Immuno compromised [Pneumonia]
[Adrenal insufficiency]
1611USA006233 07jun-2017 UNITED STATES followup:12 Secondary adrenal insufficiency [Secondary adrenocortical
insufficiency]
[Pneumonia]
1504USA009886 07jun-2017 UNITED STATES followup:2 Pneumonitis [Pneumonitis]
lung infection (grade 3) [Lung infection]
[Neuritis]
1704DEU004539 07jun-2017 GERMANY followup:5
worsening of muscle weakness [Muscular weakness]

1705ISR004910 07jun-2017 ISRAEL followup:3 [Renal failure]

1705DNK011316 07jun-2017 DENMARK followup:4 [Blood bilirubin increased]

1705TUR003433 07jun-2017 TURKEY followup:5 [Lung infection]

[Blood alkaline phosphatase increased]
1705COL003418 07jun-2017 COLOMBIA followup:3

Pgina 8 de 18
IV
[Dyspnoea]
1705DNK007083 07jun-2017 DENMARK followup:4
fever [Pyrexia]

1501USA004606 07jun-2017 UNITED STATES followup:3 [Seronegative arthritis]

[Oesophagitis]
1705DEU004326 07jun-2017 GERMANY followup:2
Oesophagitis [Oesophagitis]

1705AUS015889 07jun-2017 AUSTRALIA initial [Acute kidney injury]

[Pulmonary embolism]
febrile neutropenia [Febrile neutropenia]
1611USA003812 07jun-2017 UNITED STATES followup:8
urinary tract infection [Urinary tract infection]
lung infection-hospital-acquired pneumonia [Pneumonia]
1706DEU001634 07jun-2017 GERMANY initial [Pulmonary haemorrhage]
[Chills]
1702USA011912 07jun-2017 UNITED STATES followup:2 Diarrhea [Diarrhoea]
worsening of systolic dysfunction [Systolic dysfunction]
V 07jun-2017

1705USA005549 07jun-2017 UNITED STATES followup:4 [Myocarditis]

1705ISR015421 07jun-2017 ISRAEL followup:1 [Hepatic enzyme increased]

TAIWAN, PROVINCE OF
1705TWN006966 07jun-2017 CHINA followup:3 [Blood bilirubin increased]

1612ZAF005482 07jun-2017 SOUTH AFRICA followup:5 [Anaemia]

[Hypoxia]
1705USA013896 07jun-2017 UNITED STATES followup:1 H.Flu Pneumonia [Pneumonia haemophilus]
[Pneumonia]
1608BRA004922 07jun-2017 BRAZIL followup:10
Pneumonia [Pneumonia]

I 08jun-2017
[Cerebral haemorrhage]
1706USA001913 08jun-2017 UNITED STATES followup:1 Low platelets [Platelet count decreased]
[Ketoacidosis]
1612CHN007819 08jun-2017 CHINA followup:21 pneumonia [Pneumonia]
high blood glucose [Blood glucose increased]
[Adrenal insufficiency]
1608JPN001781 08jun-2017 JAPAN followup:24 Interstitial pneumonia [Interstitial lung disease]
Hypothyroidism [Hypothyroidism]
1610JPN009627 08jun-2017 JAPAN followup:3 [Liver abscess]

1705TUR015371 08jun-2017 TURKEY followup:2 [Pleural effusion]

1705RUS014172 08jun-2017 RUSSIAN FEDERATION followup:1 [Pleural effusion]

1706DNK002028 08jun-2017 DENMARK initial [Adrenal insufficiency]

1704TUR012861 08jun-2017 TURKEY followup:12 [Hepatotoxicity]

[[Blood bilirubin increased]
Increased AST [Aspartate aminotransferase increased]
1705USA007733 08jun-2017 UNITED STATES followup:2 Increased ALT [Alanine aminotransferase increased]
Hypoglycemia [Hypoglycaemia]]
1610USA008473 08jun-2017 UNITED STATES followup:4 [Retroperitoneal mass]

1705ITA004876 08jun-2017 ITALY followup:2 [Pneumonia]

[Sepsis]
1610ISR015281 08jun-2017 ISRAEL followup:21
Pancytopenia [Pancytopenia]

II 08jun-2017

1601JPN001831 08jun-2017 JAPAN followup:6 [Syncope]

[Malaise]
1605JPN000797 08jun-2017 JAPAN followup:18 Anorexia [Decreased appetite]
depression [Depression]
[Blood bilirubin increased]
1404USA000588 08jun-2017 UNITED STATES followup:6 increased alanine aminotransferase [Alanine
aminotransferase increased]

Pgina 9 de 18
 increased aspartate aminotransferase [Aspartate
aminotransferase increased]

1610ISR005101 08jun-2017 ISRAEL followup:16 Acute kidney injury]

[Blood corticotrophin decreased]

1603JPN012567 08jun-2017 JAPAN followup:8
cortisol decreased [Cortisol decreased]

1702CHN008324 08jun-2017 CHINA followup:9 [Chronic obstructive pulmonary disease]

1706FRA001532 08jun-2017 FRANCE initial [Headache]

[Pleural effusion]
Malignant Neoplasm Progression [Malignant neoplasm
progression]
1605USA013896 08jun-2017 UNITED STATES followup:18
Worsening Small Bowel Obstruction [Small intestinal
obstruction]
Worsening Ascites [Ascites]
[Pneumonia]
1612POL007093 08jun-2017 POLAND followup:10
Transient ischemic attack [Transient ischaemic attack]

1705USA005516 08jun-2017 UNITED STATES followup:2 [Cerebrovascular accident]

1705MYS015219 08jun-2017 MALAYSIA followup:2 [Inappropriate antidiuretic hormone secretion]

1701TUR001065 08jun-2017 TURKEY followup:10 [Pneumonia]

III 08jun-2017

1706JPN002805 08jun-2017 JAPAN initial [Hepatic failure]

1706GBR002033 08jun-2017 UNITED KINGDOM initial [Pleural effusion]

TAIWAN, PROVINCE OF
1703TWN014089 08jun-2017 CHINA followup:4 [Dyspnoea]

[Acute kidney injury]

1704ESP011358 08jun-2017 SPAIN initial urinary tract obstruction [Urinary tract obstruction]

1706USA001862 08jun-2017 UNITED STATES initial [Dyspnoea]

[Colectomy total]
Immune-mediated colitis [Colitis]
1704AUS003113 08jun-2017 AUSTRALIA followup:1
immune mediated colitis [Colitis]
colitis [Colitis]
[Dyspnoea]
cardiomyopathy [Cardiomyopathy]
1706USA001371 08jun-2017 UNITED STATES initial pneumonia [Pneumonia]
pulmonary edema [Pulmonary oedema]
pneumonitits [Pneumonitis]
1702SWE003851 08jun-2017 SWEDEN followup:11 [Colitis]

[Pneumonia aspiration]
1702USA003996 08jun-2017 UNITED STATES followup:3 aspiration [Aspiration]
[Febrile neutropenia]
1704AUS006650 08jun-2017 AUSTRALIA followup:5 anaemia [Anaemia]

I 09-jun-2017

1706CHN001835 09-jun-2017 CHINA followup:1 [Respiratory failure]

[Cardiac failure acute]

1704USA003334 09-jun-2017 UNITED STATES followup:1 Fatigue [Fatigue]

1705FRA008163 09-jun-2017 FRANCE followup:5 [Peritonitis]

1602JPN011528 09-jun-2017 JAPAN followup:9 [Febrile neutropenia]

[Jaundice cholestatic]
hemorrhagic septic shock [Septic shock]
Upper gastrointestinal bleeding [Upper gastrointestinal
1609FRA008338 09-jun-2017 FRANCE followup:16 haemorrhage]
cytolysis [Cell death]
ascitis [Ascites]
1706CHN003986 09-jun-2017 CHINA initial [Dyspnoea]

[Type 2 diabetes mellitus]

1609CAN009194 09-jun-2017 CANADA followup:19
diabetes type 2 [Type 2 diabetes mellitus]

1606USA008667 09-jun-2017 UNITED STATES followup:7 [Febrile neutropenia]

Pgina 10 de 18
1705FRA009212 09-jun-2017 FRANCE followup:1 [Herpes zoster]
[Septic shock]
respiratory failure [Respiratory failure]
anorexia [Decreased appetite]
vomit [Vomiting]
1704CHN013017 09-jun-2017 CHINA followup:11
nausea [Nausea]
Intermittent diarrhea [Diarrhoea]
level 4 myelosuppression [Bone marrow failure]
pulmonary infection [Lung infection]
[Pneumonitis]
1610BRA001391 09-jun-2017 BRAZIL followup:10 Respiratory infection [Respiratory tract infection]
Respiratory insufficiency [Respiratory failure]
[Stomatitis]
1701AUS000499 09-jun-2017 AUSTRALIA followup:9 febrile illness [Pyrexia]

II 09-jun-2017
[Pulmonary hypertension]
1704USA013752 09-jun-2017 UNITED STATES followup:3 pericardial effusion [Pericardial effusion]
pulmonary hypertension [Pulmonary hypertension]
[Chronic obstructive pulmonary disease]
1608USA003192 09-jun-2017 UNITED STATES followup:12 Thromboembolic event (pulmonary embolism) [Pulmonary
embolism]
1705JPN012588 09-jun-2017 JAPAN followup:3 [Hyperglycaemia]

[Hyperglycaemia]
1705USA011548 09-jun-2017 UNITED STATES followup:1 Hyponatremia [Hyponatraemia]
[Blood creatinine increased]
1704ESP011472 09-jun-2017 SPAIN followup:11
Anemia due to treatment [Anaemia]

1705ISR011415 09-jun-2017 ISRAEL followup:3 [Blood creatinine increased]

1704USA001336 09-jun-2017 UNITED STATES followup:2 [Thrombocytopenia]

1706USA001421 09-jun-2017 UNITED STATES followup:1 [Infection]

[Pyrexia]
hyponatremia [Hyponatraemia]
1512USA003672 09-jun-2017 UNITED STATES followup:14 lactic acidosis [Lactic acidosis]
acute mental status changes [Mental status changes]
elevated AST [Aspartate aminotransferase increased]
[Adrenal insufficiency]
1608JPN001781 09-jun-2017 JAPAN followup:25 Interstitial pneumonia [Interstitial lung disease]
Hypothyroidism [Hypothyroidism]
[Hyponatraemia]
1611USA012105 09-jun-2017 UNITED STATES followup:8 hepatitis [Hepatitis]
hepatic failure [Hepatic failure]
1704CHN007173 09-jun-2017 CHINA followup:13 [Diabetes mellitus]

III 09-jun-2017

1706USA003877 09-jun-2017 UNITED STATES initial Respiratory failure]

1705USA007977 09-jun-2017 UNITED STATES followup:2 [Myocarditis]

[Acute kidney injury]

1701POL001460 09-jun-2017 POLAND followup:11 hematuria [Haematuria]

1705USA005516 09-jun-2017 UNITED STATES followup:3 [Cerebrovascular accident]

[Ileus]
Acute kidney injury [Acute kidney injury]
1608DEU004547 09-jun-2017 GERMANY followup:11
Superinfection of drainage canal in stoma [Stoma site
infection]
[Adrenal insufficiency]
hyponatremia [Hyponatraemia]
1705USA012418 09-jun-2017 UNITED STATES initial
hyponatremia [Hyponatraemia]
intermittent abdominal pain [Abdominal pain]
[Cardiac failure]
1704CZE009943 09-jun-2017 CZECH REPUBLIC followup:9 Deterioration of the overall condition [General physical health
deterioration]
1705JPN011093 09-jun-2017 JAPAN followup:3 [Sinus tachycardia]
[Pleural effusion]
pneumonitis [Pneumonitis]
1606USA007982 09-jun-2017 UNITED STATES followup:1
thrombolytic event- pulmonary embolism [Pulmonary
embolism]

Pgina 11 de 18
 [Lung infection]
1705TUR003433 09-jun-2017 TURKEY followup:6
pulmonary sepsis [Pulmonary sepsis]

1704CHL003273 09-jun-2017 CHILE followup:7 [Pneumonia]]

1611ISR007474 09-jun-2017 ISRAEL followup:20 [Osteomyelitis]

[
IV 09-jun-2017

1706DEU001634 09-jun-2017 GERMANY followup:1 [Pulmonary haemorrhage]

1706ZAF002010 09-jun-2017 SOUTH AFRICA initial [Organising pneumonia]

[Hypertrophic osteoarthropathy]
worsening bilateral lower extremity edema [Oedema
1608USA015526 09-jun-2017 UNITED STATES followup:14 peripheral]
fever [Pyrexia]
pneumonia [Pneumonia]
1705CHL009360 09-jun-2017 CHILE initial [Pulmonary embolism]

1704USA014674 09-jun-2017 UNITED STATES followup:7 [Pneumonia]

1705CHN009357 09-jun-2017 CHINA followup:3 [Anaemia]

1706JPN003810 09-jun-2017 JAPAN initial [Hepatic function abnormal]

[Pyrexia]
1704USA003443 09-jun-2017 UNITED STATES followup:1 Chills intermittent [Chills]

1610USA013915 09-jun-2017 UNITED STATES followup:2 [Bronchitis]

I 12-jun-2017

1612MEX002616 12-jun-2017 MEXICO followup:8 [Angioedema]

1701BRA004273 12-jun-2017 BRAZIL followup:12 [Acute kidney injury]

1612TUR002195 12-jun-2017 TURKEY followup:13 Varicella zoster virus infection]

[Adrenal insufficiency]
1704ESP007186 12-jun-2017 SPAIN followup:7
Hypophysitis [Hypophysitis]

1706USA001512 12-jun-2017 UNITED STATES followup:1 [Intestinal obstruction]

[Hepatotoxicity]
1704TUR008907 12-jun-2017 TURKEY followup:12
Hypercalcemia [Hypercalcaemia]
[Febrile neutropenia]
1606JPN011061 12-jun-2017 JAPAN followup:12 pneumoniae [Pneumonia]

1704IRL005567 12-jun-2017 IRELAND followup:8 [Liver function test increased]

1706JPN003810 12-jun-2017 JAPAN followup:1 [Hepatic function abnormal]

1705PRT003396 12-jun-2017 PORTUGAL followup:2 [Haemorrhage]

II 12-jun-2017

1705CHL008120 12-jun-2017 CHILE followup:3 [Type 1 diabetes mellitus]

1706FRA004656 12-jun-2017 FRANCE initial [Hepatocellular injury]

1706USA001781 12-jun-2017 UNITED STATES initial [Death]

1706FRA004689 12-jun-2017 FRANCE initial [Pulmonary embolism]

1705DNK011316 12-jun-2017 DENMARK followup:5 [Blood bilirubin increased]

1705CZE015239 12-jun-2017 CZECH REPUBLIC followup:2 [IIIrd nerve disorder]

1705FRA008163 12-jun-2017 FRANCE Followup:6 [Peritonitis]

1706DNK002028 12-jun-2017 DENMARK followup:1 [Adrenal insufficiency]

[Pancytopenia]
1604USA010727 12-jun-2017 UNITED STATES followup:10
venal occlusive disease [Venoocclusive disease]

Pgina 12 de 18
 hypotension [Hypotension]

1705FRA003271 12-jun-2017 FRANCE followup:1 [Diabetic metabolic decompensation]

III 12-jun-2017

1606JPN013631 12-jun-2017 JAPAN followup:8 [Pneumonia]

[Malaise]
1605JPN000797 12-jun-2017 JAPAN followup:9 Anorexia [Decreased appetite]
depression [Depression]
1706USA004616 12-jun-2017 UNITED STATES initial [Overdose]

1704JPN000142 12-jun-2017 JAPAN followup:7 [Pneumonia aspiration]

1706JPN004742 12-jun-2017 JAPAN initial [Lung infection]

[Urinary tract infection]

1703ESP002519 12-jun-2017 SPAIN followup:3 febrile neutropenia [Febrile neutropenia]

1610JPN009627 12-jun-2017 JAPAN followup:4 [Liver abscess]

[Acute kidney injury]

1704ESP011358 12-jun-2017 SPAIN followup:1 urinary tract obstruction [Urinary tract obstruction]
[Diarrhoea]
1703JPN013384 12-jun-2017 JAPAN followup:8
Dehydration [Dehydration]
[Immune system disorder]
1701USA004870 12-jun-2017 UNITED STATES followup:24 encephalitis [Encephalitis]
Hypercalcemia [Hypercalcaemia]
IV 12-jun-2017

1705CHL009360 12-jun-2017 CHILE followup:1 [Pulmonary embolism]

1704TUR012305 12-jun-2017 TURKEY followup:3 [Pneumonia]

[Dehydration]
Nausea [Nausea]
1705USA010477 12-jun-2017 UNITED STATES followup:1
Vomiting [Vomiting]
atrial fibrillation [Atrial fibrillation]
1706FRA001532 12-jun-2017 FRANCE followup:1 [Headache]

1705JPN011093 12-jun-2017 JAPAN followup:4 [Sinus tachycardia]

[Cardiac failure]
1705USA015304 12-jun-2017 UNITED STATES followup:2 shortness of breath [Dyspnoea]

1705AUS015889 12-jun-2017 AUSTRALIA followup:1 Acute kidney injury]

1706USA000504 12-jun-2017 UNITED STATES followup:1 [Large intestinal obstruction]

1705ISR011415 12-jun-2017 ISRAEL followup:4 Blood creatinine increased]

1706IRL003114 12-jun-2017 IRELAND initial [Constipation]

V 12-jun-2017

1609USA007496 12-jun-2017 UNITED STATES followup:1 [Pleural effusion]

[Vasculitis cerebral]
1705AUS008871 12-jun-2017 AUSTRALIA followup:3 acute kidney injury [Acute kidney injury]
acute pancreatitis [Pancreatitis acute]
1704FRA010939 12-jun-2017 FRANCE followup:1 [General physical health deterioration]

1609GBR012974 12-jun-2017 UNITED KINGDOM followup:8 [Colitis]

[Back pain]
ELEVATED LIVER ENZYME LEVELS [Hepatic enzyme
1706USA001854 12-jun-2017 UNITED STATES followup:1 increased]
RUQ PAIN AND ELEVATED LIVER TEST [Abdominal pain
upper]
[Cardiac failure congestive]
1705USA014133 12-jun-2017 UNITED STATES followup:3 pneumonitis [Pneumonitis]
right lung pneumonia [Pneumonia]
1701USA009044 12-jun-2017 UNITED STATES followup:3 [Hypoglycaemia]

Pgina 13 de 18
1705USA012340 12-jun-2017 UNITED STATES followup:1 [Adrenal insufficiency]

1703USA012819 12-jun-2017 UNITED STATES followup:5 [Polymyalgia rheumatica]

1608MEX010596 12-jun-2017 MEXICO followup:17 [Acute kidney injury]

VI 12-jun-2017
[Pneumonia]
thromboembolic event, DVT and pulmonary embolism
1605NOR012057 12-jun-2017 NORWAY followup:3 [Pulmonary embolism]
Numbness left side [Hypoaesthesia]
1706USA000494 12-jun-2017 UNITED STATES followup:1 [Arthritis]

1705DNK002390 12-jun-2017 DENMARK followup:6 [Peripheral motor neuropathy]

1702SWE003851 12-jun-2017 SWEDEN followup:12 [Colitis]

1705USA002486 12-jun-2017 UNITED STATES followup:1 [Adrenal insufficiency]

TAIWAN, PROVINCE OF
1703TWN014089 12-jun-2017 CHINA followup:5 [Dyspnoea]

I 13-jun-2017
[Anaemia]
1701MYS009610 13-jun-2017 MALAYSIA followup:9 pruritis [Pruritus]
[Neuralgia]
1703AUS003926 13-jun-2017 AUSTRALIA followup:10 Neuralgia [Neuralgia]

1706FRA004683 13-jun-2017 FRANCE initial [Peritonitis]

1706CHN003986 13-jun-2017 CHINA followup:1 [Dyspnoea]

Pleural effusion]
1612BRA005536 13-jun-2017 BRAZIL followup:14
Pleural effusion [Pleural effusion]
[Cardiac failure acute]
1511ARG000499 13-jun-2017 ARGENTINA followup:23 Pleural effusion [Pleural effusion]
total bilirubin increase [Blood bilirubin increased]
[Anaemia]
1701CHN011993 13-jun-2017 CHINA followup:22 platelet count decreased [Platelet count decreased]
platelet count decreased [Platelet count decreased]
[Pneumonitis]
1610BRA001391 13-jun-2017 BRAZIL followup:11 Respiratory infection [Respiratory tract infection]
Respiratory insufficiency [Respiratory failure]
[Septic shock]
respiratory failure [Respiratory failure]
anorexia [Decreased appetite]
vomit [Vomiting]
1704CHN013017 13-jun-2017 CHINA followup:12
nausea [Nausea]
Intermittent diarrhea [Diarrhoea]
level 4 myelosuppression [Bone marrow failure]
pulmonary infection [Lung infection]
[Ileus paralytic]
1701SWE005839 13-jun-2017 SWEDEN followup:7
vomiting [Vomiting]

II 13-jun-2017

1706JPN003810 13-jun-2017 JAPAN followup:2 [Hepatic function abnormal]

[Blood creatinine increased]

1704ESP011472 13-jun-2017 SPAIN followup:12
Anemia due to treatment [Anaemia]

1705MYS015219 13-jun-2017 MALAYSIA followup:3 [Inappropriate antidiuretic hormone secretion]

1706FRA005355 13-jun-2017 FRANCE initial [Confusional state]

[Hydrothorax]
1705RUS006992 13-jun-2017 RUSSIAN FEDERATION followup:5
Atelectasis right G2 [Atelectasis]
[Pneumonia]
1510DEU006434 13-jun-2017 GERMANY followup:23 Malignant neoplasm Progression [Malignant neoplasm
progression]
1706BRA004712 13-jun-2017 BRAZIL initial [Death]

1610JPN009627 13-jun-2017 JAPAN followup:5 [Liver abscess]

1704CHN012849 13-jun-2017 CHINA followup:4 [Pulmonary embolism]

Pgina 14 de 18
 1701TUR001065 13-jun-2017 TURKEY followup:11 [Pneumonia]

III 13-jun-2017
[Sudden death]
1705USA005549 13-jun-2017 UNITED STATES followup:5 Myocarditis [Myocarditis]

1704TUR012305 13-jun-2017 TURKEY followup:4 [Pneumonia]

1702JPN008719 13-jun-2017 JAPAN followup:7 [Fatigue]

Colitis]
partial small bowel obstruction [Small intestinal obstruction]
Intractable nausea [Nausea]
1705USA006722 13-jun-2017 UNITED STATES followup:1
Intractable vomiting [Vomiting]
diarrhoea [Diarrhoea]
diarrhea [Diarrhoea]
[Chills]
Nausea [Nausea]
1705USA002093 13-jun-2017 UNITED STATES followup:2 Headache [Headache]
Vomiting NOS [Vomiting]
Fever [Pyrexia]
[Febrile neutropenia]
1702ARG011245 13-jun-2017 ARGENTINA followup:14
deep vein thrombosis [Deep vein thrombosis]
[Alanine aminotransferase increased]
1701TUR011979 13-jun-2017 TURKEY followup:18 AST increased [Aspartate aminotransferase increased]
pleural effusion [Pleural effusion]
1706USA004779 13-jun-2017 UNITED STATES initial [Angina pectoris]

1706ZAF002010 13-jun-2017 SOUTH AFRICA followup:1 [Organising pneumonia]

1706GBR003972 13-jun-2017 UNITED KINGDOM initial [Lower respiratory tract infection]

IV 13-jun-2017
Respiratory failure]
1706USA003739 13-jun-2017 UNITED STATES initial gastritis [Gastritis]

1703DEU006245 13-jun-2017 GERMANY followup:4 [Chronic obstructive pulmonary disease]

1706JPN004800 13-jun-2017 JAPAN initial [Vena cava embolism]

[Vomiting]
1702FRA006804 13-jun-2017 FRANCE followup:8 abdominal pain [Abdominal pain]

1606JPN013631 13-jun-2017 JAPAN followup:9 [Pneumonia]

1704GBR001378 13-jun-2017 UNITED KINGDOM followup:1 [Malignant neoplasm progression]

[Malaise]
1605JPN000797 13-jun-2017 JAPAN followup:20 Anorexia [Decreased appetite]
depression [Depression]
1701CHN010283 13-jun-2017 CHINA followup:14 [Pneumonia]

TAIWAN, PROVINCE OF
1705TWN003438 13-jun-2017 CHINA followup:2 [Glomerulonephritis membranous]

[Pleural effusion]
1701PHL010538 13-jun-2017 PHILIPPINES followup:6
Pneumonia in the Immuno compromised [Pneumonia]

V 13-jun-2017

1703NZL010870 13-jun-2017 NEW ZEALAND followup:6 Chest pain]

[Aspartate aminotransferase increased]

1705USA010667 13-jun-2017 UNITED STATES initial increased bilirubin [Blood bilirubin increased]

1612ZAF005482 13-jun-2017 SOUTH AFRICA followup:6 [Anaemia]

[Vasculitis cerebral]
1705AUS008871 13-jun-2017 AUSTRALIA followup:4 acute kidney injury [Acute kidney injury]
acute pancreatitis [Pancreatitis acute]
[Acute kidney injury]
1704ESP011358 13-jun-2017 SPAIN followup:2
urinary tract obstruction [Urinary tract obstruction]

1705DNK002390 13-jun-2017 DENMARK followup:7 [Peripheral motor neuropathy]

[Oesophagitis]
1705DEU004326 13-jun-2017 GERMANY followup:3
Oesophagitis [Oesophagitis]

1702USA005534 13-jun-2017 UNITED STATES followup:9 [Hyperglycaemia]

Pgina 15 de 18
 [Acute kidney injury]
1702GBR006862 13-jun-2017 UNITED KINGDOM followup:11 hepatitis [Hepatitis]
[Suicide attempt]
1705AUS003275 13-jun-2017 AUSTRALIA initial
Kidney Failure [Renal failure]

VI 13-jun-2017
[Dehydration]
Nausea [Nausea]
1705USA010477 13-jun-2017 UNITED STATES followup:2 Vomiting [Vomiting]
atrial fibrillation [Atrial fibrillation]
[Fatigue]
1511ESP009853 13-jun-2017 SPAIN followup:13 Asthenia [Asthenia]

1705CHN014116 13-jun-2017 CHINA followup:3 [Pneumonia]

1705JPN012588 13-jun-2017 JAPAN followup:4 [Hyperglycaemia]

[Pulmonary embolism]
1612USA006965 13-jun-2017 UNITED STATES followup:2 aspiration pneumonitis [Pneumonia aspiration]

1701CAN008918 13-jun-2017 CANADA followup:8 [Dysphagia]

1706USA003075 13-jun-2017 UNITED STATES initial [Metastases to central nervous system]

1706USA002676 13-jun-2017 UNITED STATES initial [Aplasia pure red cell]

1706JPN002805 13-jun-2017 JAPAN followup:1 [Hepatic failure]

[Pancytopenia]
1608ISR001315 13-jun-2017 ISRAEL followup:10 Infusion related reaction [Infusion related reaction]

VII 13-jun-2017

1701AUS009618 13-jun-2017 AUSTRALIA followup:3 [Febrile neutropenia]

1705KOR006325 13-jun-2017 KOREA, REPUBLIC OF followup:2 [Ileus]

[Febrile neutropenia]
1704AUS006650 13-jun-2017 AUSTRALIA followup:6
anaemia [Anaemia]

1612FRA009689 13-jun-2017 FRANCE followup:10 [Type 1 diabetes mellitus]

[Urticaria]
1610FRA013349 13-jun-2017 FRANCE Followup10
obstructive pyelonephritis [Pyelonephritis]
[Respiratory failure]
1706USA003739 13-jun-2017 UNITED STATES followup:1 microperforation of small bowel [Small intestinal perforation]
[Malnutrition]
bad tolerance nasogastric tube [Device intolerance]
1706FRA005118 13-jun-2017 FRANCE initial dehydration [Dehydration]
lose of weight (12kg) [Weight decreased]
I 14-jun-2017

1705USA010733 14-jun-2017 UNITED STATES followup:2 [Aphasia]

1705GTM000046 14-jun-2017 GUATEMALA followup:5 [Lung abscess]

1610JPN009627 14-jun-2017 JAPAN followup:6 [Liver abscess]

1706AUS003849 14-jun-2017 AUSTRALIA initial [Hyperglycaemia]

1705TUR015371 14-jun-2017 TURKEY followup:3 Pleural effusion]

[Adrenal insufficiency]
hyponatremia [Hyponatraemia]
1705USA012418 14-jun-2017 UNITED STATES followup:1 hyponatremia [Hyponatraemia]
hyponatremia [Hyponatraemia]
intermittent abdominal pain [Abdominal pain]
TAIWAN, PROVINCE OF
1705TWN006966 14-jun-2017 CHINA followup:4 Blood bilirubin increased]

1703POL001889 14-jun-2017 POLAND followup:12 [Acute kidney injury]

1705KOR015314 14-jun-2017 KOREA, REPUBLIC OF followup:1 [Toxic encephalopathy]

1706BEL004624 14-jun-2017 BELGIUM initial [Biliary dilatation]

II 14-jun-2017

Pgina 16 de 18
 1705PRT003396 14-jun-2017 PORTUGAL followup:3 [Haemorrhage]

1705CZE015239 14-jun-2017 CZECH REPUBLIC followup:3 [IIIrd nerve disorder]

[Hyperglycaemia]
1705USA005491 14-jun-2017 UNITED STATES followup:2
pneumonitis [Pneumonitis]

1612MEX002616 14-jun-2017 MEXICO followup:9 Angioedema]

[Sudden death]
1705USA005549 14-jun-2017 UNITED STATES followup:6
Myocarditis [Myocarditis]
[Sepsis]
1610ISR015281 14-jun-2017 ISRAEL followup:22 Pancytopenia [Pancytopenia]

1702HUN009462 14-jun-2017 HUNGARY followup:10 [Thrombocytopenia]

[Pneumonitis]
1705ESP011420 14-jun-2017 SPAIN initial respiratory infection [Respiratory tract infection]

1705USA006951 14-jun-2017 UNITED STATES followup:1 [Lacunar infarction]

1612DEU009954 14-jun-2017 GERMANY followup:7 [Lipase increased]

III 14-jun-2017

1706JPN004800 14-jun-2017 JAPAN followup:1 [Vena cava embolism]

1706DNK002028 14-jun-2017 DENMARK followup:2 [Adrenal insufficiency]

1706GBR005957 14-jun-2017 UNITED KINGDOM initial [Acute kidney injury]

[Pain in extremity]
1706USA004431 14-jun-2017 UNITED STATES initial Thrombocytopenia [Thrombocytopenia]
nausea [Nausea]
1701JPN003136 14-jun-2017 JAPAN followup:26 [Gastroenteritis eosinophilic]

1706USA005853 14-jun-2017 UNITED STATES initial [Liver function test increased]

1606PHL000033 14-jun-2017 PHILIPPINES followup:10 [Anaemia]

TAIWAN, PROVINCE OF
1703TWN014089 14-jun-2017 CHINA followup:6 [Dyspnoea]

1706AUS004795 14-jun-2017 AUSTRALIA initial [Adverse event]

1706FRA001532 14-jun-2017 FRANCE followup:2 [Headache]

IV 14-jun-2017

1705FRA009212 14-jun-2017 FRANCE followup:2 [Herpes zoster]

1706BEL005887 14-jun-2017 BELGIUM initial [Sudden death]

1704USA004681 14-jun-2017 UNITED STATES followup:7 [Cardiac failure]

[Septic shock]
respiratory failure [Respiratory failure]
anorexia [Decreased appetite]
vomit [Vomiting]
1704CHN013017 14-jun-2017 CHINA followup:13
nausea [Nausea]
Intermittent diarrhea [Diarrhoea]
level 4 myelosuppression [Bone marrow failure]
pulmonary infection [Lung infection]
[Atrial fibrillation]
1512USA009168 14-jun-2017 UNITED STATES followup:3 worsening hypertension [Hypertension]
Cardiac troponin T increased [Troponin T increased]
1706FRA004683 14-jun-2017 FRANCE followup:1 [Peritonitis]

1612NOR012887 14-jun-2017 NORWAY followup:10 [Sarcoidosis]

1703NOR003423 14-jun-2017 NORWAY followup:3 [Neutrophil count decreased]

[Pneumonitis]
Febrile neutropenia [Febrile neutropenia]
1704ITA003431 14-jun-2017 ITALY followup:2 Thrombocytopenia [Thrombocytopenia]
Anemia [Anaemia]
right pneumonitis [Pneumonitis]

Pgina 17 de 18
1706FRA001845 14-jun-2017 FRANCE initial [Generalised oedema]

V 14-jun-2017
[Lower respiratory tract infection]
1706GBR003972 14-jun-2017 UNITED KINGDOM followup:1 Raised ALT [Alanine aminotransferase increased]

1705AUS002361 14-jun-2017 AUSTRALIA followup:3 [Inflammation]

1705ISR011415 14-jun-2017 ISRAEL followup:5 [Blood creatinine increased]

1706CAN005341 14-jun-2017 CANADA initial [Staphylococcal sepsis]

[Febrile neutropenia]
1607USA003401 14-jun-2017 UNITED STATES followup:9 Severe Sepsis [Sepsis]
Elevated Liver Function [Hepatic function abnormal]
1705CHN009357 14-jun-2017 CHINA followup:4 [Anaemia]

1611FIN007675 14-jun-2017 FINLAND followup:10 [Psoriasis]

Pgina 18 de 18