NCT01154140 · OUTCOME

Percentage of Participants With Laboratory Test Abnormalities By Maximum Severity: National Cancer Institute Common Terminology Criteria for Adverse Event (Version 4.0) Grade 1 to 4 Chemistry Test Abnormalities

A Clinical Trial Testing The Efficacy Of Crizotinib Versus Standard Chemotherapy Pemetrexed Plus Cisplatin Or Carboplatin In Patients With ALK Positive Non Squamous Cancer Of The Lung · Source last updated 2017-11-06

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

Measure: NUMBER
Unit: percentage of participants
Interval / dispersion: Not reported
Time frame: Baseline up to follow up period (up to 72 months)

What was measured

ALT/AST (Grade\[g\]1:\>ULN-3\*ULN,g2:\>3-5\*ULN,g3:\>5-20\*ULN,g4:\>20\*ULN);Alkaline Phosphatase (g1:\>ULN-2.5\*ULN,g2:\>2.5-5\*ULN,g3:\>5-20\*ULN,g4:\>20\*ULN);Creatinine (g1:\>ULN-1.5\*ULN,g2:\>1.5-3\*ULN,g3:\>3-6\*ULN,g4:\>6\*ULN);hyperglycemia (g1:\>ULN-160,g2:\>160-250,g3:\>250-500,g4:\>500mg/dL);bilirubin(total) (g1:\>ULN-1.5\*ULN,g2:\>1.5-3\*ULN,g3:\>3-10\*ULN,g4:\>10\*ULN);hypoglycaemia (g1:\<LLN-55,g2:\<55-40,g3:\<40-30,g4:\<30mg/dL);hyperkalemia (g1:\>ULN-5.5,g2:\>5.5-6,g3:\>6-7,g4:\>7mmol/L);hypokalemia (g1:\<LLN-3,g2:\<LLN-3,g3:\<3-2.5,g4:\<2.5mmol/L);hypermagnesemia (g1:\>ULN-3,g3:\>3-8,g4:\>8mg/dL);hypocalcemia (g1:\<LLN-8,g2:\<8-7,g3:\<7-6,g4:\<6mg/dL); hypercalcemia (g1:\>ULN-11.5,g2:\>11.5-12.5,g3:\>12.5-13.5,g4:\>13.5mg/dL);hypomagnesemia (g1:\<LLN-1.2,g2:\<1.2-0.9,g3:\<0.9-0.7,g4:\<0.7mg/dL);hyponatremia (g1:\<LLN-130,g3:\<130-120,g4:\<120mmol/L);hypoalbuminemia (g1:\<LLN-3,g2:\<3-2,g3:\<2,g4:lifethreatening);hypophosphatemia (g1:\<LLN-2.5,g2:\<2.5-2,g3:\<2-1,g4:\<1mg/dL). Participant\>=1 abnormality given.

Analysis population: Safety analysis population included all randomized subjects who received at least 1 dose of study treatment, with treatment assignments designated according to actual study treatment received during the first cycle. Here, N=participants who were evaluable for this outcome measure. Here, "n"=participants who were evaluable at specified time points.

Groups in this outcome

Crizotinib

Crizotinib 250 mg capsule, orally twice daily was administered in treatment cycle of 21 days. Participants could continue crizotinib treatment beyond the time of RECIST v1.1 defined PD, as determined by IRR, at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.

Chemotherapy

Standard doses of chemotherapy (pemetrexed/cisplatin or pemetrexed/carboplatin) were administered intravenously on Day 1 of each cycle for a maximum of 6 cycles. Pemetrexed 500 mg per meter square (m)\^2 IV infusion according to standard of care was administered over 10 min; either cisplatin 75 mg/m\^2 IV infusion was administered approximately 30 min after the end of the pemetrexed infusion or carboplatin was administered at a dose calculated to produce an AUC of 5 or 6 mg\*min/mL, approximately 30 min after end of pemetrexed infusion.

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