includes serious, life-threatening and fatal adverse reactions
†Grouped terms: arthralgia, back pain, bone pain, myalgia, musculoskeletal pain, neck pain, non-cardiac chest pain, pain
and pain in extremity
‡Grouped terms: aspartate aminotransferase increased, alanine aminotransferase increased, transaminases increased, liverfunction test increased, hepatic failure, hepatocellular injury and hepatotoxicity
§Grouped terms: blood bilirubin increased and hyperbilirubinemia
¶Grouped terms: asthenia, fatigue and malaise
#Grouped terms: body temprature increased and fever
þGrouped terms: edema, face edema, fluid retention, generalized edema, localized edema, edema peripheral, peripheral
swelling and swelling face
ßGrouped terms: diarrhea and diarrhea hemorrhagic
àGrouped terms: aphthous ulcer, mucosal inflammation, mouth hemorrhage, mouth ulceration, oral mucosal blistering,
oral mucosal erythema, stomatitis and tongue ulceration
èGrouped terms: hematemesis and vomiting
ðGrouped terms: acute respiratory failure, acute respiratory distress syndrome, dyspnea, dyspnea exertional, hypoxia,
pulmonary edema, respiratory distress, respiratory failure, tachypnea and wheezing
øGrouped terms: dermatitis, dermatitis bullous, dermatitis contact, drug eruption, dermatitis exfoliative, eczema asteatotic,
lichen planus, erythema, palmar-plantar erythrodysethesia syndrome, photosensitivity reaction, psoriasis, rash, rash
erythematous, rash follicular, rash generalized, rash macular, rash maculo-papular, rash papular, rash pruritic, seborrheic
dermatitis, skin exfoliation and toxic skin eruption
ýGrouped terms: pneumonia, lung infection, pneumonia fungal, respiratory syncytial virus infection, respiratory tractinfection, lung infiltration, organizing pneumonia, lower respiratory tract infection bacterial, pneumonia aspiration,
pneumonitis, interstitial lung disease, lower respiratory tract infection and pneumonia viral₤Grouped terms: sepsis, bacteremia, septic shock, bacterial sepsis and neutropenic sepsis
¥Grouped terms: blood pressure decreased, hypotension and orthostatic hypotension
ŒGrouped terms: blood pressure increased, hypertension and orthostatic hypertension
ɶGrouped terms: headache and tension headache
ÐGrouped terms: dizziness, dizziness postural and vertigo
AGrouped terms: acute kidney injury, blood creatinine increased, chronic kidney disease, oliguria, renal disorder, renal
failure, renal impairment, renal injury and renal tubular necrosis
BGrouped terms: abdominal discomfort, abdominal pain, abdominal pain lower, abdominal pain upper, epigastric
discomfort and gastrointestinal pain
Other clinically significant adverse reactions occurring in ≤10% of patients included: electrocardiogram QT prolonged(7%), cardiac failure* (4%), pericardial effusion (3%), pericarditis (2%), differentiation syndrome (1%), anaphylacticreaction (1%) and posterior reversible encephalopathy syndrome (1%).
*Grouped terms: cardiac failure, cardiac failure congestive, cardiomyopathy, cardiomegaly, chronic left ventricular failure and ejection fractiondecreased.
Changes in selected post-baseline laboratory values that were o
