Empagliflozin in Patients with Chronic Kidney Disease

• p. 8 Results

  the hazard ratio was 0.73 (95% CI 0.59 to 0.89) (Tables 2 and S5)

• p. 52 Table S5

  Table S5. Other Secondary and Tertiary Outcomes

Judge's note: Table 2 contains 0.73 (0.59-0.89). Table S5 (supp p52) lists kidney progression components, ESKD or any-cause death, kidney progression or any-cause death, MACE and gout, but not ESKD or CV death. S5 may have been cited for the ESKD component (0.67), so this is minor.

Second check: another model agreed

• p. 16 Table 1, urinary ACR categories

  ≥30 ≤300

• p. 13 Figure 2, urinary ACR subgroups

  ≥30 <300

• p. 9 Discussion

  3192 (48%) participants with a urinary ACR below 300 mg/g

• p. 40 Figure S4, key subgroups

  >300

Only the authors can say what is right here.

Judge's note: Table 1 (p16) prints ≥30 ≤300 and >300. Figure 2 (p13) prints ≥30 <300 and ≥300 with the same denominators. Supplement figures (e.g. p40) use ≤300/>300. The Discussion's 3192 below 300 equals 665+663+927+937. Only the authors can say which boundary was used.

Second check: another model agreed

• p. 17 Table 2, All-cause hospitalization row

  All-cause hospitalization¶

• p. 18 Table 2 footnotes

  End-stage kidney disease, defined as start of maintenance dialysis or receipt of a kidney transplant.

• p. 17 Table 2 rows

  Kidney disease progression

Judge's note: The p17 upright image shows the markers ¶, §, # and * only. The p18 upright image lists the footnotes †, ‡, §, # and *, with no ¶ footnote. The hospitalization explanation is in the general note.

Second check: another model agreed

• p. 17 SOP9a section 1.3.1

  definitions (see Section 0)

Judge's note: The supp p17 image shows 'Section 0'. No Section 0 exists. The definitions of dialysis and transplant are in sections 2.1.1 and 2.1.2 (supp text lines 971 and 982), so this appears to be an unresolved field reference.

Second check: another model agreed

• p. 56 Table S9a, Liver function tests header

  Relative Difference (SE)

Judge's note: p56 image checked. 13/3273 minus 12/3265 is 0.03 percentage points, and 2/3273 minus 4/3265 is -0.06. The relative difference for 13 vs 12 would be about +8%.

Second check: another model agreed

• p. 8 Results, Tertiary and Exploratory Outcomes

  faster rate of annual decline (i.e. patients with diabetes, higher eGFR, or higher baseline urinary ACR)

• p. 44 Figure S7, chronic slope, Diabetes rows

  -1.05 (0.12) -2.73 (0.12)

Only the authors can say what is right here.

Judge's note: Fig S7 (supp p44): placebo decline is essentially identical with and without diabetes. The description holds for eGFR ≥45 (-3.60) and ACR >300 (-4.11), but not for diabetes. The larger difference in diabetes (1.68 vs 1.09) comes from slower decline in the empagliflozin arm.

Second check: another model agreed

• p. 8 Clinical Measurements and Laboratory Assessments

  but no significant effect on glycated hemoglobin (Table S9)

• p. 56 Table S9a, HbA1c All

  -0.39 (-0.77, -0.01)

Only the authors can say what is right here.

Judge's note: Table S9a (supp p56) prints a CI for the overall HbA1c difference whose upper bound is below zero. The authors should say whether 'no significant effect' refers to clinical relevance, to the subgroups by diabetes status, or to another criterion.

Second check: another model agreed

• p. 28 SOP9a section 5.1 Ketoacidosis, criterion iii

  or urine ketones of at least

Only the authors can say what is right here.

Judge's note: The supp p28 image shows the sentence ending at 'at least', followed by a blank line. The urine ketone threshold is missing, and only the authors can supply it.

Second check: another model agreed

• p. 2 Affiliations

  Chinese academy of Medical Sciences

Judge's note: Seen in the page 2 crop: lower-case 'academy' in the proper name.

Second check: none (judge only)

• p. 2 Author list

  Rajat Deo, M.D. M.T.R.,

Judge's note: Crop of page 2 shows 'M.D. M.T.R.'. Other dual degrees on the page use a slash, so this is a minor consistency point.

Second check: none (judge only)

• p. 4 Introduction, last paragraph

  patients with an eGFR) less than 30

• p. 4 Introduction, paragraph 3

  patients with an eGFR) less than 30 ml per minute per 1.73 m2

• p. 4 Introduction, last paragraph

  patients with an eGFR) less than 30 ml per minute

• p. 16 Table 1 footnote

  not listed in the Table) or not specified

Judge's note: Both stray parentheses are visible in the page images (p4 Introduction; p16 Table 1 footnote ‡).

Second check: none (judge only)

• p. 9 Discussion, paragraph 2

  required participants to have a urinary ACR of 200 mg/g

• p. 4 Introduction, paragraph 2

  a urinary ACR of at least 200 mg/g

Judge's note: Page 9 image shows 'a urinary ACR of 200 mg/g and an eGFR of 25 to 75'. The page 4 crop shows 'a urinary ACR of at least 200 mg/g'. The intended meaning is clear, so this is cosmetic: add 'at least'.

Second check: none (judge only)

• p. 5 Methods, Outcomes

  was defined as either as measured at two consecutive

Judge's note: Page 5 crop shows 'defined as either as measured'; the first 'as' is redundant.

Second check: none (judge only)

• p. 8 Results, Tertiary and Exploratory Outcomes

  slower in the empgalfilozin

• p. 8 Tertiary and Exploratory Outcomes

  empgalfilozin

• p. 8

  slower in the empgalfilozin group in all the key subgroups

Judge's note: Visible on the page 8 image; should be 'empagliflozin'.

Second check: none (judge only)

• p. 8 Safety Outcomes

  serious or symptomatic dehydrations

Judge's note: Visible on page 8; 'dehydration' is the usual form.

Second check: none (judge only)

• p. 8 Tertiary and Exploratory Outcomes

  subgroups of participant with faster

Judge's note: Visible on page 8; should be 'participants'.

Second check: none (judge only)

• p. 8 Tertiary and Exploratory Outcomes

  hazard ratio, 0.93 95% CI 0.76-1.12

Judge's note: Visible on page 8. Elsewhere the paper writes 'hazard ratio, x; 95% CI a to b'.

Second check: none (judge only)

• p. 9 Discussion, final (summary) paragraph

  cardiovascular causes in a broad range of patients with CKD at risk of progression.

Judge's note: Page 9 image confirms that the phrase 'in a broad range of patients with CKD' appears twice in the same sentence and reads as an editing leftover. The same sentence also reads 'with an eGFR 30 ml per minute', which appears to be missing a word.

Second check: none (judge only)

• p. 15 Table 1, Prior diabetes type, Other/unknown, placebo

  (0.0%)

• p. 15 Table 1, Prior diabetes type, Other/unknown, placebo

  15 (0.0%)

Judge's note: The p15 image shows '15 (0.0%)', while the empagliflozin cell shows '21 (1%)' and other small cells show '(<1%)'. The value 0.0% is not a correct rounding of 0.45% at one decimal place.

Second check: none (judge only)

• p. 16 Table 1 footnote ‡

  not listed in the Table) or not specified

Judge's note: The p16 image confirms there is a closing parenthesis with no matching opening one.

Second check: none (judge only)

• p. 17 Table 2, Ketoacidosis, placebo

  (0.0%)

Judge's note: The p17 upright image shows both cells. 1/3305 is 0.03%, which rounds to 0.0%, but this breaks the table's own <0.1% convention. Table S7 was not checked.

Second check: none (judge only)

• p. 17 SOP9a section 1.3.1

  are similarly be based on LCC reports

• p. 17

  Assessments of all-cause hospitalization are similarly be based on LCC reports

Judge's note: The supp p17 image confirms the wording. It should read 'are similarly based' or 'will similarly be based'.

Second check: none (judge only)

• p. 29 SOP9a section 5.3 AKI staging table

  ≥1-5, <2.0-times historical value(s)

Judge's note: Crop image checked: the stage 1 row reads '≥1-5, <2.0-times'. Stage 2 is '≥2.0, <3.0', so the hyphen is evidently a typo for a decimal point.

Second check: none (judge only)

• p. 48 Table S2 continuation title

  Table S2. Other Characteristics of Participants at Recruitment (continued)

• p. 48 Table S2 (continued) title

  Other Characteristics of Participants at Recruitment (continued)

• p. 47 Table S2 title

  Other Characteristics of Participants at Randomization

Judge's note: Page images checked. p47 is titled 'at Randomization', and the footnote says values are from the randomization visit. p48 is titled 'at Recruitment (continued)'.

Second check: none (judge only)

• p. 48

  GLP-1 = glucagon-like peptide-1. GFR = glomerular filtration rate.

Judge's note: The p48 image shows GFR defined twice in the same abbreviations line.

Second check: none (judge only)

• p. 51 Table S4 footnotes

  Hospitalization defined as the reason for the adverse event being serious is hospitalization.

Judge's note: p51 image checked. The only marker in the body is † on 'Cardiac disorder'. The title and all other rows carry no asterisk.

Second check: none (judge only)

• p. 54 Table S7, Lower limb amputation, Foot

  0 (<0.1%)

Judge's note: p54 image checked. The Foot row shows 0 (<0.1%) in both arms, while Hepatic congestion and Alcohol, for example, show 0 (0.0%).

Second check: none (judge only)