Table 3.
Study | Vaccinated patients (n) | Doses provided per patient | Serious (Grade 3+) adverse events (n of events) |
All adverse events (n of events) | Number of patients experiencing any AE | ||
---|---|---|---|---|---|---|---|
Total (n) |
Local complication (n) | Fever (n) |
|||||
Oh (2020) Oh (2016) |
31° | mean 7.8 (max 12) | None | 93 | 93 | 0 | NR |
Bota (2018)† | 5† | 2 autologous cells, 3 allogeneic cells* | 4 | 162 | 67 | NR | NR |
Schulze (2009) | 25 | 6 (18 patients), 7 (1 patient), 11 (1 patient), 12 (1 patient), 3 (2 patients), 4 (1 patient), 5 (3 patients) | None | 5 | 4 | 0 | 4 |
Peng (2006) | 32 | 3 | None | 62 | 7 | 30 | 20 |
Uyl-de Groot (2005), Vermorken (1999) | 128 | 4 (101 patients), 3 (1 patient), 1 (1 patient), unknown (25 patients) | None | NR | NR | NR | 128 |
Peng (2005) | 24 | 3 (24 patients), unspecified (6 patients) | None | 72 | 72 | 0 | 24 |
Kuang (2004) | 18 | Unclear | None | NR | NR | 0 | 18 |
Harris (2000)± | 205 | Unclear | None | NR | NR | NR | 162 |
Galligioni (1996) | 60 | Unclear | None | NR | NR | NR | NR |
Hoover (1993) | 41 | 4 (1 patient), 3 (40 patients), 1 (1 patient) | None | NR | 82 | NR | 41 |
Gray (1989, 1988) | 129 | NR | 1 | NR | NR | NR | NR |
Adler (1987) | 24 | ≤ 24 / Unclear | This study did not report on adverse events | ||||
Souter (1981) | 34 | 1 | This study did not report on adverse events | ||||
Embleton (1978), McIllmurray (1977) | 8 | 1 | None | NR | 4 | NR | NR |
NR not reported.
°31 patients received vaccination; 20 of these patients were randomized to the vaccine group and 11 additional patients were placed in the vaccine group in a de-randomized fashion.
†Bota (2018) was the only study to provide information on AEs for control; 8 serious AEs, 58 total AEs in control group.
*in the study by Bota et al. (2018) it was unclear how many cycles of the 2 autologous cell and 3 allogeneic cell vaccines were provided.
±although only 150 patients were considered “analyzable” in the study by Harris (2000), 205 were vaccinated.