NCT00980460 · OUTCOME

Number of Cycles on Which Grade 3 or Higher Adverse Events Coded According to CTC AE Version 5 Were Observed

Risk-Based Therapy in Treating Younger Patients With Newly Diagnosed Liver Cancer · Source last updated 2026-06-30

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: NUMBER
Unit: Cycles
Interval / dispersion: Not reported
Time frame: During protocol therapy up to 1 year after enrollment

What was measured

All grade 3 or 4 or greater non-hematological toxicities. The frequency of each toxicity type will be quantified as the number of reporting periods on which the toxicity of the relevant grade is reported. This measure does not apply to patients enrolled in the VERY LOW RISK group.

Analysis population: All eligible patients except for patients in the very low-risk group. Regimen T includes 49 cycles, Regimen F includes 269 cycles, Regimen W includes 107 cycles and Regimen H includes 124 cycles.

Groups in this outcome

Low-risk Group (Regimen T)

Patients undergo surgery and then receive adjuvant cisplatin IV over 6 hours on day 1, fluorouracil IV over 2-4 minutes on day 2, and vincristine sulfate IV over 1 minute on days 2, 9, and 16. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Cisplatin: Given IV Fluorouracil: Given IV Laboratory Biomarker Analysis: Correlative studies Therapeutic Conventional Surgery: Undergo surgery Vincristine Sulfate: Given IV

Intermediate-risk Group (Regimen F)

Patients receive C5VD chemotherapy comprising cisplatin IV over 6 hours on day 1, fluorouracil IV over 2-4 minutes on day 2, vincristine sulfate IV over 1 minute on days 2, 9, and 16, and doxorubicin hydrochloride IV over 15 minutes on days 1-2. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo surgical resection after course 2 OR surgical resection or liver transplantation after course 4 of C5VD. Patients may also receive dexrazoxane IV over 5-15 minutes on days 1-2 of courses 5 and 6. (Closed to accrual as of 3/12/2012) Cisplatin: Given IV Dexrazoxane: Given IV Doxorubicin Hydrochloride: Given IV Fluorouracil: Given IV Laboratory Biomarker Analysis: Correlative studies Liver Transplantation: Undergo liver transplant Therapeutic Conventional Surgery: Undergo surgery Vincristine Sulfate: Given IV

High-risk Group (Regimen W)

(regimen W replaced by regimen H as of Amendment 3B) Patients receive up front VI chemotherapy comprising vincristine sulfate IV on days 1 and 8 and irinotecan hydrochloride IV over 90 minutes on days 1-5. Treatment with VI repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with disease response then receive 6 courses of C5VD with 1 courses of VI in between each 2-course block. Patients with no disease response receive 6 courses of C5VD in the absence of disease progression or unacceptable toxicity. Cisplatin: Given IV Doxorubicin Hydrochloride: Given IV Fluorouracil: Given IV Irinotecan Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Therapeutic Conventional Surgery: Undergo surgery Vincristine Sulfate: Given IV

High-risk Group (Regimen H)

Patients receive up front VIT chemotherapy comprising vincristine sulfate IV over 1 minute on days 1 and 8 and irinotecan hydrochloride IV over 90 minutes on days 1-5, and temsirolimus IV over 30 minutes on days 1 and 8. Treatment with VIT repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with disease response then receive 6 courses of C5VD with 4 courses of VIT in between each 2-course block. Patients with no disease response receive 6 courses of C5VD in the absence of disease progression or unacceptable toxicity. Patients undergo tumor resection or liver transplant after course 4 of C5VD followed by 2 courses of adjuvant C5VD. Patients may also receive dexrazoxane IV over 5-15 minutes on days 1-2 of courses 5 and 6. Cisplatin: Given IV Doxorubicin Hydrochloride: Given IV Fluorouracil: Given IV Irinotecan Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Liver Transplantation: Undergo liver transplant Temsirolimus: Given IV Therapeutic Conventional Surgery: Undergo surgery Vincristine Sulfate: Given IV

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Low-risk Group (Regimen T)	51
Intermediate-risk Group (Regimen F)	105
High-risk Group (Regimen W)	32
High-risk Group (Regimen H)	40

Analysis denominator · Cycles

Group	Source count
Low-risk Group (Regimen T)	49
Intermediate-risk Group (Regimen F)	269
High-risk Group (Regimen W)	107
High-risk Group (Regimen H)	124

Reported measurements

Hearing impaired

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	1	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	20	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	4	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	4	Not reported	Not reported	Not reported	Not reported

Diarrhea

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	4	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	15	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	15	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	15	Not reported	Not reported	Not reported	Not reported

Enterocolitis

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	1	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	1	Not reported	Not reported	Not reported	Not reported

Nausea

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	1	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	10	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	10	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	3	Not reported	Not reported	Not reported	Not reported

Small intestinal obstruction

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	1	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	0	Not reported	Not reported	Not reported	Not reported

Vomiting

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	2	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	24	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	13	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	5	Not reported	Not reported	Not reported	Not reported

Abdominal distension

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	3	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	0	Not reported	Not reported	Not reported	Not reported

Abdominal pain

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	10	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	9	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	6	Not reported	Not reported	Not reported	Not reported

Colitis

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	3	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	1	Not reported	Not reported	Not reported	Not reported

Anal mucositis

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	0	Not reported	Not reported	Not reported	Not reported

Ascites

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	0	Not reported	Not reported	Not reported	Not reported

Malabsorption

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	0	Not reported	Not reported	Not reported	Not reported

Mucositis oral

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	44	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	8	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	6	Not reported	Not reported	Not reported	Not reported

Constipation

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	2	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	0	Not reported	Not reported	Not reported	Not reported

Dental caries

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	0	Not reported	Not reported	Not reported	Not reported

Typhlitis

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	2	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	2	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	1	Not reported	Not reported	Not reported	Not reported

Duodenal obstruction

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	0	Not reported	Not reported	Not reported	Not reported

Esophageal hemorrhage

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	0	Not reported	Not reported	Not reported	Not reported

Gastritis

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	0	Not reported	Not reported	Not reported	Not reported

Illeus

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	3	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	4	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	0	Not reported	Not reported	Not reported	Not reported

Oral pain

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	4	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	0	Not reported	Not reported	Not reported	Not reported

Small intestinal mucositis

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	0	Not reported	Not reported	Not reported	Not reported

Colonic hemorrhage

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	0	Not reported	Not reported	Not reported	Not reported

Dysphagia

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	0	Not reported	Not reported	Not reported	Not reported

Esophagitis

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	0	Not reported	Not reported	Not reported	Not reported

Gastroparesis

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	0	Not reported	Not reported	Not reported	Not reported

Gastric fistula

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	1	Not reported	Not reported	Not reported	Not reported

Gastrointestinal disorders - Other, specify

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	1	Not reported	Not reported	Not reported	Not reported

Obstruction gastric

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	1	Not reported	Not reported	Not reported	Not reported

Rectal mucositis

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	1	Not reported	Not reported	Not reported	Not reported

Fever

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	1	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	9	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	9	Not reported	Not reported	Not reported	Not reported

General disorders and administration site conditions - Other, specify

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	0	Not reported	Not reported	Not reported	Not reported

Pain

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	6	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	4	Not reported	Not reported	Not reported	Not reported

Multi-organ failure

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	2	Not reported	Not reported	Not reported	Not reported

Irritability

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	1	Not reported	Not reported	Not reported	Not reported

Infusion related reaction

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	1	Not reported	Not reported	Not reported	Not reported

Hypothermia

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	1	Not reported	Not reported	Not reported	Not reported

Catheter related infection

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	1	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	8	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	0	Not reported	Not reported	Not reported	Not reported

Infections and infestations - Other, specify

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	4	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	38	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	27	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	9	Not reported	Not reported	Not reported	Not reported

Mucosal infection

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	1	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	0	Not reported	Not reported	Not reported	Not reported

Otitis media

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	1	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	0	Not reported	Not reported	Not reported	Not reported

Urinary tract infection

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	1	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	3	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	3	Not reported	Not reported	Not reported	Not reported

Biliary tract infection

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	0	Not reported	Not reported	Not reported	Not reported

Abdominal infection

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	0	Not reported	Not reported	Not reported	Not reported

Bladder infection

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	2	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	0	Not reported	Not reported	Not reported	Not reported

Enterocolitis infectious

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	8	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	4	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	5	Not reported	Not reported	Not reported	Not reported

Duodenal infection

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	0	Not reported	Not reported	Not reported	Not reported

Upper respiratory infection

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	4	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	2	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	2	Not reported	Not reported	Not reported	Not reported

Eye infection

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	0	Not reported	Not reported	Not reported	Not reported

Wound infection

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	0	Not reported	Not reported	Not reported	Not reported

Sepsis

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	5	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	3	Not reported	Not reported	Not reported	Not reported

Lung infection

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	2	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	1	Not reported	Not reported	Not reported	Not reported

Peritoneal infection

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	0	Not reported	Not reported	Not reported	Not reported

Skin infection

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	7	Not reported	Not reported	Not reported	Not reported

Small intestine infection

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	0	Not reported	Not reported	Not reported	Not reported

Periorbital infection

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	1	Not reported	Not reported	Not reported	Not reported

Alanine aminotransferase increased

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	1	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	28	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	9	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	6	Not reported	Not reported	Not reported	Not reported

Aspartate aminotransferase increased

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	1	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	37	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	10	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	19	Not reported	Not reported	Not reported	Not reported

Activated partial thromboplastin time prolonged

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	2	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	3	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	1	Not reported	Not reported	Not reported	Not reported

Alkaline phosphatase increased

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	1	Not reported	Not reported	Not reported	Not reported

Blood bilirubin increased

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	7	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	2	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	5	Not reported	Not reported	Not reported	Not reported

Creatinine increased

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	3	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	1	Not reported	Not reported	Not reported	Not reported

GGT increased

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	7	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	6	Not reported	Not reported	Not reported	Not reported

Weight loss

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	6	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	4	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	6	Not reported	Not reported	Not reported	Not reported

Fibronogen decreased

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	2	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	1	Not reported	Not reported	Not reported	Not reported

Ejection fraction decreased

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	1	Not reported	Not reported	Not reported	Not reported

Investigations - Other, specify

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	0	Not reported	Not reported	Not reported	Not reported

White blood cell decreased

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	0	Not reported	Not reported	Not reported	Not reported

INR increased

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	0	Not reported	Not reported	Not reported	Not reported

CPK increased

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	1	Not reported	Not reported	Not reported	Not reported

Cholesterol high

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	1	Not reported	Not reported	Not reported	Not reported

Electrocardiogram QT corrected interval prolonged

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	1	Not reported	Not reported	Not reported	Not reported

Lipase increased

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	1	Not reported	Not reported	Not reported	Not reported

Serum amylase increased

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	1	Not reported	Not reported	Not reported	Not reported

Anorexia

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	1	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	30	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	20	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	17	Not reported	Not reported	Not reported	Not reported

Dehydration

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	3	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	13	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	3	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	12	Not reported	Not reported	Not reported	Not reported

Hyperglycemia

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	2	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	15	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	5	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	10	Not reported	Not reported	Not reported	Not reported

Hyperkalemia

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	2	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	12	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	3	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	5	Not reported	Not reported	Not reported	Not reported

Hypermagnesemia

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	2	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	4	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	0	Not reported	Not reported	Not reported	Not reported

Hypernatremia

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	2	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	3	Not reported	Not reported	Not reported	Not reported

Hypokalemia

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	4	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	48	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	12	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	29	Not reported	Not reported	Not reported	Not reported

Hyponatremia

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	1	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	22	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	6	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	10	Not reported	Not reported	Not reported	Not reported

Acidosis

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	4	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	1	Not reported	Not reported	Not reported	Not reported

Alkalosis

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	3	Not reported	Not reported	Not reported	Not reported

Hypocalcemia

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	7	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	4	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	2	Not reported	Not reported	Not reported	Not reported

Hypoalbuminemia

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	3	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	3	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	1	Not reported	Not reported	Not reported	Not reported

Hypomagnesemia

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	11	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	3	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	2	Not reported	Not reported	Not reported	Not reported

Hypophosphatemia

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	21	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	7	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	19	Not reported	Not reported	Not reported	Not reported

Tumor lysis syndrome

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	2	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	0	Not reported	Not reported	Not reported	Not reported

Hypercalcemia

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	0	Not reported	Not reported	Not reported	Not reported

Hypoglycemia

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	1	Not reported	Not reported	Not reported	Not reported

Hypertriglyceridemia

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	4	Not reported	Not reported	Not reported	Not reported

Metabolism and nutrition disorders - Other, specify

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	1	Not reported	Not reported	Not reported	Not reported

Peripheral sensory neuropathy

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	2	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	5	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	2	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	1	Not reported	Not reported	Not reported	Not reported

Oculomotor nerve disorder

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	3	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	0	Not reported	Not reported	Not reported	Not reported

Abducens nerve disorder

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	2	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	0	Not reported	Not reported	Not reported	Not reported

Peripheral motor neuropathy

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	7	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	3	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	2	Not reported	Not reported	Not reported	Not reported

Syncope

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	0	Not reported	Not reported	Not reported	Not reported

Dysphasia

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	0	Not reported	Not reported	Not reported	Not reported

Depressed level of consciousness

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	1	Not reported	Not reported	Not reported	Not reported

Seizure

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	1	Not reported	Not reported	Not reported	Not reported

Apnea

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	1	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	0	Not reported	Not reported	Not reported	Not reported

Atelectasis

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	2	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	0	Not reported	Not reported	Not reported	Not reported

Dyspnea

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	2	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	3	Not reported	Not reported	Not reported	Not reported

Bronchospasm

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	0	Not reported	Not reported	Not reported	Not reported

Hypoxia

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	10	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	2	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	6	Not reported	Not reported	Not reported	Not reported

Pleural effusion

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	2	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	2	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	1	Not reported	Not reported	Not reported	Not reported

Pulmonary edema

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	0	Not reported	Not reported	Not reported	Not reported

Stridor

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	0	Not reported	Not reported	Not reported	Not reported

Respiratory failure

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	2	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	1	Not reported	Not reported	Not reported	Not reported

Epistaxis

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	2	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	1	Not reported	Not reported	Not reported	Not reported

Wheezing

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	1	Not reported	Not reported	Not reported	Not reported

Hypertension

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	3	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	6	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	2	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	4	Not reported	Not reported	Not reported	Not reported

Hematoma

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	0	Not reported	Not reported	Not reported	Not reported

Hypotension

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	3	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	3	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	5	Not reported	Not reported	Not reported	Not reported

Vascular disorders - Other, specify

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	2	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	0	Not reported	Not reported	Not reported	Not reported

Thromboembolic event

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	1	Not reported	Not reported	Not reported	Not reported

Left ventricular systolic dysfunction

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	0	Not reported	Not reported	Not reported	Not reported

Cardiac arrest

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	3	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	0	Not reported	Not reported	Not reported	Not reported

Right ventricular dysfunction

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	2	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	0	Not reported	Not reported	Not reported	Not reported

Ventricular tachycardia

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	0	Not reported	Not reported	Not reported	Not reported

Cardiac disorders - Other, specify

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	0	Not reported	Not reported	Not reported	Not reported

Sinus tachycardia

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	4	Not reported	Not reported	Not reported	Not reported

Heart failure

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	1	Not reported	Not reported	Not reported	Not reported

Myocardial infarction

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	0	Not reported	Not reported	Not reported	Not reported

Biliary fistula

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	0	Not reported	Not reported	Not reported	Not reported

Hepatobiliary disorders - Other, specify

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	1	Not reported	Not reported	Not reported	Not reported

Hepatic hemorrhage

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	2	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	1	Not reported	Not reported	Not reported	Not reported

Portal vein thrombosis

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	0	Not reported	Not reported	Not reported	Not reported

Portal hypertension

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	0	Not reported	Not reported	Not reported	Not reported

Biliary anastomotic leak

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	0	Not reported	Not reported	Not reported	Not reported

Postoperative hemorrhage

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	0	Not reported	Not reported	Not reported	Not reported

Gastrointestinal anastomotic leak

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	2	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	0	Not reported	Not reported	Not reported	Not reported

Intraoperative hemorrhage

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	1	Not reported	Not reported	Not reported	Not reported

Arthralgia

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	0	Not reported	Not reported	Not reported	Not reported

Generalized muscle weakness

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	2	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	0	Not reported	Not reported	Not reported	Not reported

Back pain

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	0	Not reported	Not reported	Not reported	Not reported

Bone pain

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	0	Not reported	Not reported	Not reported	Not reported

Muscle weakness lower limb

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	0	Not reported	Not reported	Not reported	Not reported

Agitation

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	4	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	0	Not reported	Not reported	Not reported	Not reported

Hallucinations

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	0	Not reported	Not reported	Not reported	Not reported

Insomnia

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	1	Not reported	Not reported	Not reported	Not reported

Acute kidney injury

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	9	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	0	Not reported	Not reported	Not reported	Not reported

Renal and urinary disorders - Other, specify

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	3	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	0	Not reported	Not reported	Not reported	Not reported

Renal calculi

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	0	Not reported	Not reported	Not reported	Not reported

Proteinuria

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	1	Not reported	Not reported	Not reported	Not reported

Erythema multiforme

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	0	Not reported	Not reported	Not reported	Not reported

Skin and subcutaneous tissue disorders - Other, specify

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	2	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	1	Not reported	Not reported	Not reported	Not reported

Rash maculo-papular

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	3	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	2	Not reported	Not reported	Not reported	Not reported

Eye disorders - Other, specify

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	0	Not reported	Not reported	Not reported	Not reported

Surgical and medical procedures - Other, specify

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	0	Not reported	Not reported	Not reported	Not reported

Tumor pain

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	1	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	0	Not reported	Not reported	Not reported	Not reported

Allergic reaction

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	2	Not reported	Not reported	Not reported	Not reported

Anaphylaxis

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	2	Not reported	Not reported	Not reported	Not reported

Immune system disorders - Other, specify

Values in Cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low-risk Group (Regimen T)	0	Not reported	Not reported	Not reported	Not reported
Intermediate-risk Group (Regimen F)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen W)	0	Not reported	Not reported	Not reported	Not reported
High-risk Group (Regimen H)	1	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
1
group Id
OG001
value
20
group Id
OG002
value
4
group Id
OG003
value
4
title
Hearing impaired
categories
measurements
group Id
OG000
value
4
group Id
OG001
value
15
group Id
OG002
value
15
group Id
OG003
value
15
title
Diarrhea
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
1
title
Enterocolitis
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
10
group Id
OG002
value
10
group Id
OG003
value
3
title
Nausea
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
1
group Id
OG002
value
0
group Id
OG003
value
0
title
Small intestinal obstruction
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
24
group Id
OG002
value
13
group Id
OG003
value
5
title
Vomiting
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
group Id
OG002
value
3
group Id
OG003
value
0
title
Abdominal distension
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
10
group Id
OG002
value
9
group Id
OG003
value
6
title
Abdominal pain
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
3
group Id
OG002
value
1
group Id
OG003
value
1
title
Colitis
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
group Id
OG002
value
0
group Id
OG003
value
0
title
Anal mucositis
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
group Id
OG002
value
0
group Id
OG003
value
0
title
Ascites
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
group Id
OG002
value
0
group Id
OG003
value
0
title
Malabsorption

denom Units Selected

Cycles

denoms

counts
group Id
OG000
value
51
group Id
OG001
value
105
group Id
OG002
value
32
group Id
OG003
value
40
units
Participants
counts
group Id
OG000
value
49
group Id
OG001
value
269
group Id
OG002
value
107
group Id
OG003
value
124
units
Cycles

description

groups

description
Patients undergo surgery and then receive adjuvant cisplatin IV over 6 hours on day 1, fluorouracil IV over 2-4 minutes on day 2, and vincristine sulfate IV over 1 minute on days 2, 9, and 16. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Cisplatin: Given IV Fluorouracil: Given IV Laboratory Biomarker Analysis: Correlative studies Therapeutic Conventional Surgery: Undergo surgery Vincristine Sulfate: Given IV
id
OG000
title
Low-risk Group (Regimen T)
description
Patients receive C5VD chemotherapy comprising cisplatin IV over 6 hours on day 1, fluorouracil IV over 2-4 minutes on day 2, vincristine sulfate IV over 1 minute on days 2, 9, and 16, and doxorubicin hydrochloride IV over 15 minutes on days 1-2. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo surgical resection after course 2 OR surgical resection or liver transplantation after course 4 of C5VD. Patients may also receive dexrazoxane IV over 5-15 minutes on days 1-2 of courses 5 and 6. (Closed to accrual as of 3/12/2012) Cisplatin: Given IV Dexrazoxane: Given IV Doxorubicin Hydrochloride: Given IV Fluorouracil: Given IV Laboratory Biomarker Analysis: Correlative studies Liver Transplantation: Undergo liver transplant Therapeutic Conventional Surgery: Undergo surgery Vincristine Sulfate: Given IV
id
OG001
title
Intermediate-risk Group (Regimen F)
description
(regimen W replaced by regimen H as of Amendment 3B) Patients receive up front VI chemotherapy comprising vincristine sulfate IV on days 1 and 8 and irinotecan hydrochloride IV over 90 minutes on days 1-5. Treatment with VI repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with disease response then receive 6 courses of C5VD with 1 courses of VI in between each 2-course block. Patients with no disease response receive 6 courses of C5VD in the absence of disease progression or unacceptable toxicity. Cisplatin: Given IV Doxorubicin Hydrochloride: Given IV Fluorouracil: Given IV Irinotecan Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Therapeutic Conventional Surgery: Undergo surgery Vincristine Sulfate: Given IV
id
OG002
title
High-risk Group (Regimen W)
description
Patients receive up front VIT chemotherapy comprising vincristine sulfate IV over 1 minute on days 1 and 8 and irinotecan hydrochloride IV over 90 minutes on days 1-5, and temsirolimus IV over 30 minutes on days 1 and 8. Treatment with VIT repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with disease response then receive 6 courses of C5VD with 4 courses of VIT in between each 2-course block. Patients with no disease response receive 6 courses of C5VD in the absence of disease progression or unacceptable toxicity. Patients undergo tumor resection or liver transplant after course 4 of C5VD followed by 2 courses of adjuvant C5VD. Patients may also receive dexrazoxane IV over 5-15 minutes on days 1-2 of courses 5 and 6. Cisplatin: Given IV Doxorubicin Hydrochloride: Given IV Fluorouracil: Given IV Irinotecan Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Liver Transplantation: Undergo liver transplant Temsirolimus: Given IV Therapeutic Conventional Surgery: Undergo surgery Vincristine Sulfate: Given IV
id
OG003
title
High-risk Group (Regimen H)

param Type

NUMBER

population Description

All eligible patients except for patients in the very low-risk group. Regimen T includes 49 cycles, Regimen F includes 269 cycles, Regimen W includes 107 cycles and Regimen H includes 124 cycles.

reporting Status

POSTED

time Frame

During protocol therapy up to 1 year after enrollment

title

Number of Cycles on Which Grade 3 or Higher Adverse Events Coded According to CTC AE Version 5 Were Observed

type

PRIMARY

type Units Analyzed

Cycles

unit Of Measure

Cycles

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice