Table 2.

All grade 3 and/or serious TEAEs

Dose cohortDose (mg/kg)NGrade 3 and/or serious events
10.06252Abdominal pain—SAE, grade 3
Weight decreased—grade 3
Back pain—SAE, grade 3
20.01252Hypokalemia—grade 3
Drug hypersensitivity—SAE, grade 3
Angioedema—grade 3
30.252None
40.54Vaginal hemorrhage—grade 3
Hematomaa—SAE, grade 3
Hydronephrosis—SAE, grade 3
Urinary retention—SAE, grade 3
Acute respiratory distress syndrome—SAE, grade 3
514None
623None
743Pericardial effusion—SAE, grade 3
Bacteremia—SAE, grade 3
Urinary tract infection—SAE, grade 3
883Abdominal pain—SAE, grade 2
Leukopenia—grade 3
Pyrexiaa—SAE, grade 1
Infusion-related reactiona—SAE, grade 1
9128Diarrhea—SAE, grade 3
Hyperglycemia—grade 3
Hyponatremia—SAE, grade 3
Noncardiac chest pain—grade 3
Alanine aminotransferase increased—grade 3
Hyperbilirubinemia—SAE, grade 2
Pyrexia—Two SAEs, grade 2
Sinus tachycardia—SAE, grade 1
Contrast medium allergy—SAE, grade 2
Blood creatinine increased—SAE, grade 2
Confusional state—SAE, grade 2
10165Vomitinga—One SAE, grade 3, DLT; one SAE, grade 2
Gastroesophageal reflux—grade 3
Nauseaa—One SAE, grade 3; one SAE, grade 2
Fatiguea—grade 3
Depressed level of consciousnessa—SAE, grade 3
Somnolencea—SAE, grade 3
Pain in extremity—grade 3
Pyrexiaa—SAE, grade 2
Infusion-related reactiona—SAE, grade 2
Diplopiaa—SAE, grade 2
Speech disordera—SAE, grade 2
  • aConsidered related to MORAb-004.