5. Reporting of safety data.

Comparison 1: Systemic corticosteroids plus standard care versus standard care (plus/minus placebo)
Study	Definition as published	Way of counting	Intervention group	Control group	Study design
Angus 2020	Any SAE	SAE: participants with at least one event/participants at risk	Shock‐dependent hydrocortisone: SAE: 5/141   Fixed‐dose hydrocortisone: SAE: 4/137	SAE: 0/52     SAE: 1/49	Open‐label
Corral‐Gudino 2021	Microbiology‐proven infection and hyperglycaemia	AE, HAI: events/participants at risk   HAI, FI: participants with at least one event/participants at risk	AE: 14/35 HAI: 5/35 (events and participants) FI: 1/35	AE: 1/29 HAI: 1/29 (events and participants) FI: 0/29	Open‐label
Dequin 2020	Nosocomial infections until day 28 defined by need for antibiotics. No other SAEs/AEs.	AE, HAI: events/participants at risk   HAI: participants with at least one event/participants at risk	AE: 40/76 HAI: 40/76 (events), 28/76 (participants)	AE: 50/73 HAI: 50/73 (events), 30/73 (participants)	Double‐blind
Edalatifard 2020	All undesirable effects (adverse events)	HAI: events/participants at risk   AE: participants with at least one event/participants at risk	AE: 2/34 HAI: 1/34	AE: 2/28 HAI: 0/28	Single‐blind
Farahani 2021	Not reported	Not applicable	—	—	Double‐blind
Horby 2021	Suspected drug reactions reported	Not applicable	—	—	Open‐label
Jamaati 2021	Not reported	Not applicable	—	—	Open‐label
Jeronimo 2020	AE/SAE not explicitly reported Positive blood culture, need for insulin therapy, sepsis reported	Not applicable	—	—	Double‐blind
Munch 2021a	Serious adverse reaction reported	Not applicable	—	—	Triple‐blind
Tang 2021	Hyperglycaemia, ventilator‐associated pneumonia, stress ulcer, gastrointestinal haemorrhage	AE, HAI: participants with at least one event/participants at risk	AE: 5/43 HAI: 2/43	AE: 8/43 HAI: 1/43	Single‐blind
Tomazini 2020	Glycaemic control, nosocomial infection, other AEs	SAE, AE, HAI: participants with at least one event/participants at risk	SAE: 5/151 AE: 122/151 HAI: 30/151	SAE: 9/148 AE: 121/148 HAI: 39/148	Open‐label
Comparison 2: Methylprednisolone versus dexamethasone
Study	Definition as published	Way of counting	Methylprednisolone	Dexamethasone	Study design
Ranjbar 2021	Not reported	Not applicable	—	—	Triple‐blind
Comparison 3: High‐dose dexamethasone (12 mg/d or higher) versus low‐dose dexamethasone (6 to 8 mg/d)
Study	Definition as published	Way of counting	High‐dose	Low‐dose	Study design
Maskin 2021	SAE: effects causing disability (defined as muscular weakness with a MRC scale < 48) or death   AE: hyperglycaemia (≥ 200 mg/dL), delirium (positive CAM‐ICU or requirement of neuroleptic drugs), hospital‐acquired infections (according to investigator judgement)   HAI: as defined by the attending physician   FI: candidemia (documented as Candida sp. in blood cultures), aspergillosis (documented as Aspergillus sp. in cultures)	SAE, FI, AE, HAI: participants with at least one event/participants at risk	SAE: 42/49 AE: 49/49 HAI: 34/49 FI: 3/49	SAE: 40/49 AE: 48/49 HAI: 38/49 FI: 3/49	Open‐label
Munch 2021b	Serious adverse reaction (i.e. new episodes of septic shock, invasive fungal infection, clinically important gastrointestinal bleeding, or anaphylactic reaction to dexamethasone)   HAI: either new episode of septic shock OR invasive fungal infection, as per the elements of the composite outcome of ≥ 1 serious adverse reaction at day 28   FI: not further defined	SAE, FI, HAI: participants with at least one event/participants at risk   HAI, FI: events/participants at risk	SAE: 70/497 HAI: 27/497 (events), 50/497 (participants) FI: 15/497	SAE: 85/485 HAI: 35/485 (events), 61/485 (participants) FI: 21/485	Triple‐blind
Taboada 2021	AE: nosocomial infection, insuline use for hyperglycaemia, thrombosis, death at day 28 and death at day 60	AE, HAI: events/participants at risk	AE: 58/98 HAI: 10/98	AE: 65/102 HAI: 10/102	Open‐label
Toroghi 2021	AE: not further defined HAI: secondary infections	AE, HAI: events/participants at risk	AE: 252/86 HAI: 5/86	AE: 122/47 HAI: 1/47	Open‐label
AE: adverse event; ICU: intensive care unit; FI: fungal infection; SAE: serious adverse event; HAI: hospital‐acquired infection; SAP: statistical analysis plan