Table 3.

Listing of all grade ≥3 adverse events

 Grade of adverse event, n (%)a
345b
Any grade ≥3 AE20 (29.4)6 (8.8)5 (7.4)
Pancreatic carcinoma metastatic002 (3.0)
BCC001 (1.5)
Chondrosarcoma001 (1.5)
Pancreatic carcinoma001 (1.5)
Hyponatremia7 (10.3)1 (1.5)0
Fatigue4 (5.9)1 (1.5)0
Hyperglycemia1 (1.5)1 (1.5)0
Pyelonephritis01 (1.5)0
Adenocarcinoma pancreas01 (1.5)0
Paranoia01 (1.5)0
Presyncope01 (1.5)0
Abdominal pain5 (7.4)00
Weight decreased3 (4.4)00
Dyspnea3 (4.4)00
Pain2 (2.9)00
Dehydration2 (2.9)00
Back pain2 (2.9)00
Anemia1 (1.5)00
Leukopenia1 (1.5)00
Lymphopenia1 (1.5)00
Atrial fibrillation1 (1.5)00
Keratitis1 (1.5)00
Nausea1 (1.5)00
Vomiting1 (1.5)00
Ascites1 (1.5)00
Impaired gastric emptying1 (1.5)00
Intestinal obstruction1 (1.5)00
Pyrexia1 (1.5)00
Infection1 (1.5)00
Pneumonia1 (1.5)00
Urinary tract infection1 (1.5)00
Corneal abrasion1 (1.5)00
Transfusion reaction1 (1.5)00
Blood alkaline phosphatase increased1 (1.5)00
Blood potassium increased1 (1.5)00
Electrocardiogram QT prolonged1 (1.5)00
Myelocyte percentage increased1 (1.5)00
Neutrophil count decreased1 (1.5)00
Hyperkalaemia1 (1.5)00
Muscle spasms1 (1.5)00
Musculoskeletal chest pain1 (1.5)00
Confusional state1 (1.5)00
Hydronephrosis1 (1.5)00
Aspiration1 (1.5)00
Hypertension1 (1.5)00

aNumber and percentage of patients experiencing at least 1 event are reported at the highest grade experienced.

bAll deaths within 30 days of discontinuation of study drug were to be reported as adverse events, including deaths attributed to tumor progression.