Table 1. Open in new tab Criteria for...

Protocol-Defined Criteria^a
Normal (serum Cr <1.2 mg/dL)	Doubling of Cr up to >1.2 mg/dL OR ≥50% reduction in CrCl
Preexisting dysfunction (serum Cr ≥1.2 mg/dL)	Increases in Cr ≥1 mg/dL OR ≥20% reduction in CrCl OR Initiation of renal replacement therapy
KDIGO Criteria^b
Stage^c	Serum Cr
1	1.5–1.9 times baseline OR ≥0.3 mg/dL (≥26.5 µmol/L) increase
2	2.0–2.9 times baseline
3	3.0 times baseline OR Increase ≥4.0 mg/dL (≥353.6 µmol/L) OR Initiation of renal replacement therapy
RIFLE Criteria
Classification^c,d	GFR Criteria
Risk	Increased serum Cr × 1.5 OR GFR decrease >25%
Injury	Increased serum Cr × 2 OR GFR decrease >50%
Failure	Increased serum Cr × 3 OR GFR decrease 75% OR Serum creatinine ≥4 mg/dL (acute rise ≥0.5 mg/dL)

Protocol-Defined Criteria^a
Normal (serum Cr <1.2 mg/dL)	Doubling of Cr up to >1.2 mg/dL OR ≥50% reduction in CrCl
Preexisting dysfunction (serum Cr ≥1.2 mg/dL)	Increases in Cr ≥1 mg/dL OR ≥20% reduction in CrCl OR Initiation of renal replacement therapy
KDIGO Criteria^b
Stage^c	Serum Cr
1	1.5–1.9 times baseline OR ≥0.3 mg/dL (≥26.5 µmol/L) increase
2	2.0–2.9 times baseline
3	3.0 times baseline OR Increase ≥4.0 mg/dL (≥353.6 µmol/L) OR Initiation of renal replacement therapy
RIFLE Criteria
Classification^c,d	GFR Criteria
Risk	Increased serum Cr × 1.5 OR GFR decrease >25%
Injury	Increased serum Cr × 2 OR GFR decrease >50%
Failure	Increased serum Cr × 3 OR GFR decrease 75% OR Serum creatinine ≥4 mg/dL (acute rise ≥0.5 mg/dL)

Table 1.

Criteria for Assessment of Treatment-Emergent Nephrotoxicity

Protocol-Defined Criteria^a
Baseline Renal Function Category	Serum Cr
Normal (serum Cr <1.2 mg/dL)	Doubling of Cr up to >1.2 mg/dL OR ≥50% reduction in CrCl
Preexisting dysfunction (serum Cr ≥1.2 mg/dL)	Increases in Cr ≥1 mg/dL OR ≥20% reduction in CrCl OR Initiation of renal replacement therapy
KDIGO Criteria^b
Stage^c	Serum Cr
1	1.5–1.9 times baseline OR ≥0.3 mg/dL (≥26.5 µmol/L) increase
2	2.0–2.9 times baseline
3	3.0 times baseline OR Increase ≥4.0 mg/dL (≥353.6 µmol/L) OR Initiation of renal replacement therapy
RIFLE Criteria
Classification^c,d	GFR Criteria
Risk	Increased serum Cr × 1.5 OR GFR decrease >25%
Injury	Increased serum Cr × 2 OR GFR decrease >50%
Failure	Increased serum Cr × 3 OR GFR decrease 75% OR Serum creatinine ≥4 mg/dL (acute rise ≥0.5 mg/dL)

Protocol-Defined Criteria^a
Baseline Renal Function Category	Serum Cr
Normal (serum Cr <1.2 mg/dL)	Doubling of Cr up to >1.2 mg/dL OR ≥50% reduction in CrCl
Preexisting dysfunction (serum Cr ≥1.2 mg/dL)	Increases in Cr ≥1 mg/dL OR ≥20% reduction in CrCl OR Initiation of renal replacement therapy
KDIGO Criteria^b
Stage^c	Serum Cr
1	1.5–1.9 times baseline OR ≥0.3 mg/dL (≥26.5 µmol/L) increase
2	2.0–2.9 times baseline
3	3.0 times baseline OR Increase ≥4.0 mg/dL (≥353.6 µmol/L) OR Initiation of renal replacement therapy
RIFLE Criteria
Classification^c,d	GFR Criteria
Risk	Increased serum Cr × 1.5 OR GFR decrease >25%
Injury	Increased serum Cr × 2 OR GFR decrease >50%
Failure	Increased serum Cr × 3 OR GFR decrease 75% OR Serum creatinine ≥4 mg/dL (acute rise ≥0.5 mg/dL)

Abbreviations: AKI, acute kidney injury; Cr, creatinine; GFR, glomerular filtration rate; KDIGO, Kidney Disease: Improving Global Outcomes; RIFLE, Risk, Injury, Failure, Loss, and End-stage Kidney Disease.

^aCriteria assessed a priori.

^bCriteria assessed retrospectively.

^cIf a participant met criteria for >1 AKI stage/classification, the participant was included only once, in the “worst-case” stage/classification.

^dLoss of kidney function (>4 weeks) and end-stage kidney disease (>3 months) classifications were not included due to the study duration being less than the defined timelines.

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