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Table 2 Acute toxicity and cause of death

From: A phase I study on combined therapy with proton-beam radiotherapy and in situ tumor vaccination for locally advanced recurrent hepatocellular carcinoma

No Age/gender PBT dose/frac Skin Labo data-1 CalTUMP dose Vital sign changes Labo data-2 Cause of death
1 73/M 74 GyE/37f G2 n.p. 1/10 I. None Slight increase of CRP HF due to HCC progression
II. 37.0-37.7 in 1–2 days
III. 37.1-37.5 in 1–2 days
2 55/M 74 GyE/37 f G2 n.p. 1/10 I. 37.4 in 1 day Slight increase of CRP HF due to HCC progression
II. None
III. None
3 52/M 76.2 GyE/22 f G2 Slight increase of SGOT, SGPT 1/10 I. 37.1 in 1 day n.p. n.p.
II. None
III. None
4 63/M 76.2 GyE/22 f G2 n.p. 1/3 I. None n.p. HF due to HCC progression
II. None
III. 37.4-37.7 in 1–2 days
5 65/M 52.8 GyE/16 f G2 Increase of Bil 1/3 I. None Decrease of PT HF due to HCC progression
II. None
III. None
6 65/M 87.6 GyE/27 f G2 Increase of BUN, creat 1/3 I. None n.p. HF due to HCC progression
II. None
III. 37.4 in 1 day
7 59/M 76.2 GyE/22 f G2 n.p. 1/1 I. 37.4 - 38.0 in 1 day Slight increase of CRP n.p.
II. 37.5 - 38.4 in 1 day
III. 37.7 in 1 day
8 72/M 76.2 GyE/22 f G2 n.p. 1/1 I. None n.p. HF due to HCC progression
II. None
III. None
9 71/F 76.2 GyE/22 f G2 n.p. 1/1 I. 37.0 in 1 day Increase of SGOT, SGPT, γ-GTP, ALP, CRP n.p.
II. 37.1 in 1 day
III. 37.8 on the same day
  1. (PBT: Proton beam radiotherapy, Dose/frac: Total dose/fraction number, Labo data-1: Laboratory data changes associated with PBT, Labo data-2: Laboratory data changes associated with CalTUMP injection, HF: Hepatic failure).