Table A2.
Grade 5 All-Causality Adverse Events, Excluding Disease Progression
| Adverse Event | Figitumumab Arm (n = 338) |
Control Arm (n = 333) |
||
|---|---|---|---|---|
| No. of Patients | % | No. of Patients | % | |
| Total* | 43 | 13 | 32 | 10 |
| Pulmonary hemorrhage | 7 | 2 | 4 | 1 |
| Pneumonia | 7 | 2 | 3 | 1 |
| Cardiopulmonary failure | 5 | 1 | 2 | 1 |
| Sepsis | 4 | 1 | 1 | < 1 |
| Death | 3 | 1 | 3 | 1 |
| Pulmonary embolism | 1 | < 1 | 3 | 1 |
| Respiratory failure | 2 | 1 | 1 | < 1 |
| Renal failure | 2 | 1 | 1 | < 1 |
| Cerebrovascular accident | 0 | 3 | 1 | |
| Gastrointestinal hemorrhage | 0 | 2 | 1 | |
| Cardiovascular disorder | 2 | 1 | 0 | |
| Hemorrhage | 2 | 1 | 0 | |
| Sudden death | 1 | < 1 | 1 | < 1 |
| Performance status decreased | 1 | < 1 | 1 | < 1 |
| Arrhythmia | 1 | < 1 | 0 | |
| Emphysema | 1 | < 1 | 0 | |
| Hypovolemic shock | 1 | < 1 | 0 | |
| Hypoxia | 1 | < 1 | 0 | |
| Myocardial infarction | 1 | < 1 | 0 | |
| Multiorgan failure | 1 | < 1 | 0 | |
| Neutropenia | 1 | < 1 | 0 | |
| Neutropenic sepsis | 1 | < 1 | 0 | |
| Staphylococcal infection | 1 | < 1 | 0 | |
| Toxicity to various agents | 1 | < 1 | 0 | |
| Asphyxia | 0 | 1 | < 1 | |
| Cardiac failure | 0 | 1 | < 1 | |
| Dehydration | 0 | 1 | < 1 | |
| Dyspnea | 0 | 1 | < 1 | |
| Pulmonary edema | 0 | 1 | < 1 | |
| Suicide | 0 | 1 | < 1 | |
| Superior vena cava syndrome | 0 | 1 | < 1 | |
*
P = .22 by two-sided Fisher's exact test. Some patients had more than one grade 5 adverse event.