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Table 2 30-day post-operative morbidity: adverse events reported during and within 30 days of surgery according to NCI-CTC AE v 3.0 (per protocol population)

From: Systemic chemotherapy plus cetuximab after complete surgery in the treatment of isolated colorectal peritoneal carcinoma: COCHISE phase II clinical trial

Description

AE

Grade

Surgery-related

SAE

Haemorrhage/bleeding

Pelvic haematoma

Grade 2

Probable

No

Haemorrhage/bleeding

Haemorrhage

Grade 3

Certain

Yes, expected

Constitutional symptomsa

Weight loss

Grade 3

Certain

No

Renal/genitourinarya

Left urethral fistula

Grade 3

Certain

Yes, expected

Neurologya

Depression

Grade 4

N/A

No

Surgery/intra-operative injurya

Intra-peritoneal collection

Grade 1

Certain

No

Gastrointestinalb

Anastomotic colon fistula

Grade 2

Certain

No

Cardiac arrhythmiab

Tachycardia

Grade 2

N/A

No

  1. AE adverse events, SAE severe adverse events
  2. aThese 4 AE were for the same patient
  3. bThese two AE were for the same patient