Table 2

Highest grade adverse event (AE) observed in 19 patients during Ad-p53 (INGN 201) and radiation therapy

Adverse eventsaGrade 1b,cGrade 2b,cGrade 3b,cGrade 4b,cTotal patients with AEd
Fever2 (11)13 (68)0015 (79)
Pain7 (37)5 (26)1 (5)013 (68)
Weakness4 (21)4 (21)3 (16)011 (58)
Nausea9 (47)01 (5)010 (53)
Chills7 (37)3 (16)0010 (53)
Esophagitis6 (32)3 (16)009 (47)
Dyspnea6 (32)1 (5)1 (5)08 (42)
Vomiting5 (26)3 (19)008 (42)
Pneumothorax4 (21)3 (16)007 (37)
Arrhythmia5 (26)002 (11)7 (37)
Hemoptysis4 (21)2 (11)006 (32)
Anorexia3 (16)01 (5)04 (21)
Hypotension01 (5)1 (5)02 (11)
Anemia002 (11)02 (11)
Confusion001 (5)01 (5)
Hallucination001 (5)01 (5)
  • a Adverse events listed as descriptive or verbatim term from medical records, not otherwise coded.

  • b Toxicity defined by National Cancer Institute common toxicity criteria (Grade 1–4); percentage of patients with this level of toxicity in parentheses.

  • c Highest grade toxicity associated with Ad-p53 (INGN 201) and radiation therapy treatment; percentage of patients with this level of toxicity in parentheses.

  • d Total number of patients treated with Ad-p53 (INGN 201) and radiation therapy with AE.