Table 1 Overview of subgroups for pharmacodynamic and efficacy assessments

Lymphocytes (normal range: 1–4 × 10⁹/L) [37]

 ALC^low

ALC < 1.0 × 10⁹/L (lymphopenia)

 IgM^low

IgM  ≤ 0.8 g/L [12]

 ALC^low + IgM^low

As above

 % of patients maintaining/reaching ALC^normal over time

ALC ≥ 1.0 × 10⁹/L

Neutrophils^† (normal range: 2.5–8.0 × 10⁹/L) [37]

 ANC^normal

ANC < 8.0 × 10⁹/L

 ANC^high

ANC ≥ 8.0 × 10⁹/L (neutrophilia)

 IgM^low

 IgM ≤ 0.8 g/L [12]

 ANC^normal + IgM^low

As above

 ANC^high + IgM^low

As above

 % of patients maintaining ANC^normal over time

ANC < 8.0 × 10⁹/L

NLR (mild disease: 6 to < 9, moderate disease: 9 to < 18, critical disease: ≥ 18) [38]

 NLR^high

Combined ALC^low + ANC^high resulting in NLR > 9

 NLR^high + IgM^low

As above

 % of patients maintaining/reaching mild disease over time

NLR < 9.0

PCT (normal range/non-infected: ≤ 0.1 µg/L) [39]

 PCT^high

PCT ≥ 2 µg/L (systemic bacterial infection threshold)

 PCT^≤10 µg/L

PCT ≤ 10 µg/L (up to severe systemic bacterial infection)

 PCT^≤10 µg/L + IgM^low

As above

 PCT^≤10 µg/L + NLR^high

As above

 PCT^≤10 µg/L + CRP^high

As above and below

CRP (normal range: 0–10 mg/L) [40]

 CRP^high

CRP ≥ 70 mg/L

 CRP^low

CRP < 70 mg/L

 CRP^high + IgM^low

As above

 CRP^high + ALC^low

As above

 CRP^high + NLR^high

As above