Table 3 Signal strength of AEs of immune checkpoint inhibitors at the preferred terms level in FAERS database.

Gastrointestinal disorders

Diarrhoea

Nausea

Vomiting

Stomatitis

Constipation

Abdominal Pain

Colitis

Abdominal Pain Upper

Dry Mouth

Abdominal Discomfort

Dysphagia

Oral Pain

Abdominal Distension

Dyspepsia

Ascites

Intestinal Perforation

Intestinal Obstruction

Glossodynia

Pancreatitis

Large Intestine Perforation

Haematochezia

Gastrointestinal Disorder

1.14 (0.98,1.32)

0.65 (0.53,0.79)

0.58 (0.46,0.73)

1.60 (1.21,2.11) *

0.89 (0.67,1.17)

0.66 (0.50,0.88)

1.39 (0.98,1.98)

1.02 (0.68,1.52)

1.20 (0.78,1.85)

1.68 (1.04,2.71) *

2.30 (1.32,4.00) *

1.21 (0.74,1.99)

1.73 (1.00,3.00) *

1.55 (0.89,2.70)

0.77 (0.44,1.36)

0.64 (0.36,1.14)

0.89 (0.48,1.66)

2.07 (1.02,4.20) *

0.53 (0.28,0.97)

1.01 (0.49,2.06)

2.33 (1.02,5.31) *

1.32 (0.63,2.76)

1.14 (2.96)

0.65 (19.85)

0.58 (21.76)

1.60 (11.27)

0.89 (0.72)

0.67 (8.24)

1.39 (3.37)

1.02 (0.01)

1.20 (0.70)

1.67 (4.54)

2.29 (9.15) *

1.21 (0.57)

1.73 (3.91)

1.55 (2.48)

0.77 (0.83)

0.64 (2.32)

0.89 (0.13)

2.07 (4.27) *

0.53 (4.38)

1.01 (0.00)

2.33 (4.28) *

1.32 (0.53)

0.14 (−1.53)

−0.49 (−2.15)

−0.63 (−2.30)

0.47 (−1.20)

−0.13 (−1.81)

−0.46 (−2.13)

0.34 (−1.34)

0.02 (−1.67)

0.19 (−1.50)

0.52 (−1.18)

0.80 (−0.92)

0.20 (−1.50)

0.55 (−1.16)

0.45 (−1.26)

−0.29 (−1.99)

−0.51 (−2.20)

−0.12 (−1.83)

0.71 (−1.03)

−0.75 (−2.44)

0.01 (−1.72)

0.81 (−0.96)

0.29 (−1.45)

1.10 (0.95)

0.71 (0.59)

0.65 (0.51)

1.39 (1.05)

0.91 (0.69)

0.73 (0.55)

1.27 (0.89)

1.01 (0.68)

1.14 (0.74)

1.43 (0.89)

1.74 (1.00)

1.15 (0.70)

1.46 (0.84)

1.37 (0.78)

0.82 (0.46)

0.70 (0.40)

0.92 (0.49)

1.63 (0.81)

0.60 (0.32)

1.01 (0.49)

1.75 (0.77)

1.22 (0.58)

Metabolism and Nutrition Disorders

Decreased appetite

Dehydration

Hyponatraemia

Diabetes mellitus

Feeding disorder

Type 1 diabetes mellitus

Hypophagia

Hyperkalaemia

0.92 (0.76,1.13)

0.51 (0.38,0.69)

0.47 (0.28,0.79)

1.64 (0.83,3.22)

2.62 (1.25,5.52) *

0.92 (0.47,1.82)

1.12 (0.54,2.32)

1.89 (0.86,4.17)

0.92 (0.62)

0.52 (19.78)

0.47 (8.31)

1.64 (2.10)

2.62 (6.99) *

0.92 (0.05)

1.12 (0.09)

1.89 (2.58)

−0.09 (−1.76)

−0.77 (−2.44)

−0.89 (−2.57)

0.50 (−1.23)

0.90 (−0.85)

−0.09 (−1.80)

0.12 (−1.61)

0.63 (−1.13)

0.94 (0.77)

0.59 (0.44)

0.54 (0.32)

1.41 (0.72)

1.87 (0.89)

0.94 (0.48)

1.09 (0.53)

1.55 (0.70)

Neoplasms Benign, Malignant and Unspecified (Incl Cysts and Polyps)

Malignant neoplasm progression

1.35 (1.14,1.60) *

1.34 (12.08)

0.31 (−1.36)

1.24 (1.04)

Injury, Poisoning and Procedural Complications

Product use issue

Inappropriate schedule of product administration

Product use in unapproved indication

Off label use

Incorrect dose administered

Product dose omission issue

Intentional product use issue

Product prescribing issue

Fall

15.92 (12.11,20.93) *

20.01 (14.07,28.45) *

1.69 (1.36,2.11) *

0.36 (0.28,0.46)

12.17 (6.62,22.35) *

3.38 (1.99,5.74) *

2.27 (1.38,3.75) *

24.26 (7.30,80.59) *

0.74 (0.41,1.33)

15.37 (703.59) *

19.49 (551.04) *

1.68 (22.25)

0.36 (67.77)

12.10 (106.08) *

3.37 (22.93) *

2.27 (10.96) *

24.20 (59.35) *

0.74 (1.00)

1.75 (0.08) *

1.80 (0.13)

0.52 (−1.15)

−1.21 (−2.88)

1.69 (−0.02)

1.09 (−0.62)

0.79 (−0.92)

1.84 (0.09)

−0.33 (−2.03)

3.36 (2.56) *

3.48 (2.45) *

1.44 (1.15)

0.43 (0.33)

3.22 (1.75)

2.12 (1.25)

1.72 (1.05)

3.58 (1.08)

0.79 (0.44)

Hepatobiliary disorders

Hepatitis

Liver disorder

Drug-induced liver injury

1.19 (0.66,2.17)

1.13 (0.58,2.20)

2.59 (1.20,5.61) *

1.19 (0.34)

1.13 (0.14)

2.59 (6.33) *

0.19 (−1.52)

0.13 (−1.59)

0.89 (−0.86)

1.14 (0.63)

1.10 (0.57)

1.86 (0.86)

Nervous system disorders

Headache

Neuropathy peripheral

Dizziness

Somnolence

Cerebrovascular accident

Balance disorder

Memory impairment

Hypoaesthesia

Cerebral haemorrhage

Paraesthesia

Posterior reversible encephalopathy syndrome

Tremor

Taste disorder

Seizure

Hypersomnia

1.17 (0.92,1.48)

1.26 (0.87,1.83)

0.73 (0.50,1.08)

0.82 (0.51,1.32)

0.62 (0.38,1.04)

1.77 (0.97,3.23)

1.62 (0.87,3.04)

1.37 (0.73,2.57)

1.30 (0.66,2.55)

0.98 (0.51,1.88)

0.79 (0.41,1.54)

0.63 (0.33,1.20)

0.88 (0.45,1.71)

0.56 (0.28,1.10)

1.59 (0.74,3.43)

1.17 (1.66)

1.26 (1.52)

0.73 (2.51)

0.82 (0.67)

0.63 (3.35)

1.77 (3.62)

1.62 (2.32)

1.37 (0.95)

1.30 (0.57)

0.98 (0.00)

0.79 (0.48)

0.63 (2.01)

0.88 (0.15)

0.56 (2.92)

1.59 (1.44)

0.16 (−1.51)

0.24 (−1.44)

−0.35 (−2.03)

−0.22 (−1.91)

−0.54 (−2.22)

0.57 (−1.15)

0.49 (−1.23)

0.32 (−1.40)

0.27 (−1.45)

−0.02 (−1.74)

−0.26 (−1.97)

−0.53 (−2.24)

−0.15 (−1.86)

−0.67 (−2.37)

0.47 (−1.27)

1.12 (0.88)

1.18 (0.82)

0.79 (0.53)

0.86 (0.54)

0.69 (0.42)

1.49 (0.82)

1.40 (0.75)

1.25 (0.67)

1.21 (0.61)

0.99 (0.51)

0.84 (0.43)

0.69 (0.36)

0.90 (0.46)

0.63 (0.32)

1.39 (0.65)

Renal and Urinary Disorders

Proteinuria

Acute kidney injury

Renal impairment

Renal failure

1.23 (0.90,1.68)

0.71 (0.46,1.10)

0.29 (0.18,0.48)

0.55 (0.31,0.97)

1.23 (1.69)

0.71 (2.34)

0.30 (26.16)

0.55 (4.38)

0.22 (−1.46)

−0.38 (−2.07)

−1.48 (−3.16)

−0.69 (−2.38)

1.16 (0.85)

0.77 (0.50)

0.36 (0.22)

0.62 (0.35)

Infections and Infestations

Urinary tract infection

Sepsis

Pneumonia

Covid-19

0.59 (0.40,0.87)

0.76 (0.47,1.21)

0.71 (0.41,1.23)

1.46 (0.79,2.71)

0.59 (7.23)

0.76 (1.39)

0.71 (1.52)

1.46 (1.49)

−0.61 (−2.29)

−0.31 (−2.00)

−0.38 (−2.08)

0.39 (−1.33)

0.66 (0.44)

0.80 (0.50)

0.77 (0.44)

1.31 (0.71)

Endocrine disorders

Hypothyroidism

Thyroid disorder

Hyperthyroidism

Adrenal insufficiency

Immune-mediated hypothyroidism

0.82 (0.65,1.05)

3.10 (2.06,4.68) *

1.37 (0.88,2.13)

0.32 (0.18,0.57)

18.17 (4.07,81.21)

0.82 (2.54)

3.09 (32.28) *

1.37 (2.00)

0.32 (16.81)

18.15 (27.79) *

−0.21 (−1.89)

1.02 (−0.67)

0.33 (−1.36)

−1.37 (−3.05)

1.79 (−0.04)

0.86 (0.68)

2.03 (1.35)

1.25 (0.81)

0.39 (0.22)

3.45 (0.77)

Immune system disorders

Hypersensitivity

0.37 (0.19,0.72)

0.37 (9.38)

−1.18 (−2.87)

0.44 (0.23)

General Disorders and Administration Site Conditions

Fatigue

Asthenia

Death

Pyrexia

Drug ineffective

Pain

Malaise

Adverse event

Ill-defined disorder

Feeling abnormal

Peripheral swelling

Gait disturbance

Illness

Chills

Drug intolerance

No adverse event

General physical health deterioration

Oedema peripheral

Adverse drug reaction

Mucosal inflammation

Swelling

Gait inability

Drug interaction

Treatment failure

Feeling cold

1.58 (1.38,1.81) *

0.94 (0.75,1.18)

1.05 (0.80,1.37)

0.50 (0.38,0.65)

1.87 (1.38,2.55) *

1.15 (0.86,1.54)

0.48 (0.35,0.64)

12.46 (6.24,24.88) *

12.15 (6.07,24.31) *

1.98 (1.29,3.06) *

1.40 (0.91,2.15)

1.65 (1.00,2.72) *

2.31 (1.20,4.42) *

0.73 (0.42,1.29)

0.59 (0.34,1.02)

1.41 (0.75,2.66)

0.80 (0.44,1.44)

0.90 (0.50,1.64)

2.65 (1.29,5.43) *

0.77 (0.41,1.46)

4.32 (1.65,11.37) *

3.36 (1.37,8.28) *

1.16 (0.56,2.41)

4.32 (1.65,11.37) *

1.78 (0.81,3.89)

1.55 (44.16)

0.94 (0.30)

1.05 (0.11)

0.50 (28.63)

1.87 (16.48)

1.15 (0.88)

0.48 (24.13)

12.40 (84.39) *

12.10 (81.57) *

1.98 (9.96)

1.40 (2.42)

1.65 (3.98)

2.30 (6.71) *

0.73 (1.19)

0.59 (3.61)

1.41 (1.15)

0.80 (0.56)

0.90 (0.12)

2.65 (7.66) *

0.77 (0.64)

4.32 (10.51) *

3.36 (7.86) *

1.16 (0.17)

4.32 (10.51) *

1.78 (2.15)

0.45 (−1.22)

−0.07 (−1.74)

0.05 (−1.63)

−0.80 (−2.47)

0.62 (−1.06)

0.15 (−1.53)

−0.86 (−2.53)

1.69 (−0.02)

1.69 (−0.03)

0.67 (−1.02)

0.35 (−1.34)

0.51 (−1.20)

0.80 (−0.93)

−0.35 (−2.05)

−0.61 (−2.30)

0.36 (−1.36)

−0.25 (−1.95)

−0.11 (−1.82)

0.91 (−0.84)

−0.29 (−2.00)

1.24 (−0.56)

1.08 (−0.70)

0.16 (−1.57)

1.24 (−0.56)

0.58 (−1.18)

1.37 (1.19)

0.95 (0.76)

1.03 (0.79)

0.57 (0.44)

1.54 (1.13)

1.11 (0.83)

0.55 (0.41)

3.24 (1.62)

3.22 (1.61)

1.59 (1.03)

1.27 (0.83)

1.42 (0.86)

1.74 (0.91)

0.78 (0.45)

0.66 (0.38)

1.28 (0.68)

0.84 (0.47)

0.92 (0.51)

1.88 (0.92)

0.82 (0.43)

2.37 (0.90)

2.12 (0.86)

1.12 (0.54)

2.37 (0.90)

1.49 (0.68)

Skin and Subcutaneous Tissue Disorders

Rash

Palmar-plantar erythrodysaesthesia syndrome

Pruritus

Blister

Rash pruritic

Urticaria

Skin exfoliation

Dry skin

Erythema

Rash macular

Skin lesion

1.74 (1.39,2.17) *

0.95 (0.69,1.33)

1.35 (0.92,1.99)

3.03 (1.72,5.34) *

3.35 (1.80,6.23) *

1.43 (0.82,2.51)

2.24 (1.20,4.19) *

1.45 (0.71,2.97)

0.29 (0.16,0.55)

4.32 (1.65,11.37) *

6.06 (2.07,17.72) *

1.73 (24.57)

0.95 (0.08)

1.35 (2.42)

3.02 (16.29) *

3.34 (16.40) *

1.43 (1.60)

2.24 (6.68) *

1.45 (1.03)

0.29 (17.01)

4.32 (10.51) *

6.05 (14.05) *

0.55 (−1.12)

−0.05 (−1.73)

0.31 (−1.37)

1.01 (−0.71)

1.08 (−0.65)

0.37 (−1.34)

0.77 (−0.95)

0.38 (−1.36)

−1.49 (−3.17)

1.24 (−0.56)

1.42 (−0.39)

1.46 (1.17)

0.97 (0.69)

1.24 (0.85)

2.01 (1.14)

2.11 (1.14)

1.29 (0.74)

1.71 (0.91)

1.30 (0.63)

0.36 (0.19)

2.37 (0.90)

2.68 (0.92)

Musculoskeletal and Connective Tissue Disorders

Arthralgia

Myalgia

Pain in extremity

Back pain

Muscle spasms

Muscular weakness

Bone pain

Arthritis

Myositis

Musculoskeletal stiffness

Limb discomfort

2.09 (1.68,2.61) *

2.35 (1.71,3.23) *

2.00 (1.47,2.74) *

0.73 (0.51,1.05)

2.02 (1.27,3.21) *

1.19 (0.74,1.91)

1.64 (0.95,2.82)

2.12 (1.07,4.20) *

2.07 (1.02,4.20) *

2.79 (1.27,6.13) *

4.16 (1.67,10.35) *

2.07 (44.91) *

2.34 (29.48) *

2.00 (19.86) *

0.73 (2.95)

2.02 (9.24) *

1.19 (0.52)

1.63 (3.21)

2.12 (4.86) *

2.07 (4.27) *

2.79 (7.18) *

4.16 (11.12) *

0.71 (−0.96)

0.81 (−0.87)

0.68 (−1.00)

−0.35 (−2.03)

0.69 (−1.01)

0.18 (−1.51)

0.50 (−1.21)

0.73 (−1.01)

0.71 (−1.03)

0.95 (−0.81)

1.22 (−0.57)

1.64 (1.31)

1.75 (1.28)

1.60 (1.17)

0.78 (0.55)

1.61 (1.01)

1.14 (0.71)

1.41 (0.82)

1.66 (0.84)

1.63 (0.81)

1.93 (0.88)

2.33 (0.94)

Respiratory, Thoracic and Mediastinal Disorders

Dysphonia

Dyspnoea

Cough

Pneumonitis

Pulmonary embolism

Pleural effusion

1.40 (1.08,1.83) *

0.44 (0.32,0.60)

1.05 (0.72,1.52)

1.41 (0.84,2.37)

0.51 (0.32,0.82)

0.78 (0.44,1.41)

1.40 (6.37)

0.44 (27.30)

1.05 (0.06)

1.41 (1.72)

0.51 (7.96)

0.78 (0.66)

0.35 (−1.33)

−0.96 (−2.64)

0.05 (−1.63)

0.36 (−1.35)

−0.78 (−2.46)

−0.27 (−1.97)

1.27 (0.98)

0.51 (0.37)

1.03 (0.71)

1.28 (0.76)

0.58 (0.36)

0.83 (0.46)

Investigations

Blood pressure increased

Weight decreased

Platelet count decreased

Blood pressure abnormal

Hepatic enzyme increased

Blood thyroid stimulating hormone increased

Thyroid function test abnormal

White blood cell count decreased

Thyroid hormones increased

Aspartate aminotransferase increased

Blood magnesium decreased

Alanine aminotransferase increased

Thyroid hormones decreased

Liver function test increased

Blood glucose increased

Blood creatinine increased

Red blood cell count decreased

Liver function test abnormal

1.17 (0.97,1.42)

1.60 (1.27,2.02) *

0.48 (0.36,0.65)

7.68 (4.38,13.48) *

2.12 (1.31,3.44) *

2.05 (1.23,3.40) *

3.74 (1.97,7.10) *

0.55 (0.34,0.88)

8.08 (3.16,20.65) *

1.14 (0.62,2.12)

1.25 (0.67,2.32)

0.98 (0.53,1.84)

4.37 (1.87,10.24) *

3.03 (1.36,6.74) *

1.51 (0.76,3.03)

0.79 (0.41,1.54)

1.33 (0.65,2.71)

2.02 (0.91,4.49)

1.17 (2.73)

1.59 (16.01)

0.49 (24.29)

7.65 (70.56) *

2.12 (9.73) *

2.04 (7.97) *

3.74 (18.85) *

0.55 (6.26)

8.07 (27.03) *

1.14 (0.19)

1.25 (0.48)

0.98 (0.00)

4.37 (13.82) *

3.02 (8.14) *

1.51 (1.39)

0.79 (0.48)

1.33 (0.63)

2.02 (3.08) *

0.17 (−1.50)

0.47 (−1.20)

−0.85 (−2.52)

1.53 (−0.18)

0.73 (−0.97)

0.70 (−1.01)

1.15 (−0.58)

−0.69 (−2.38)

1.55 (−0.22)

0.14 (−1.57)

0.23 (−1.48)

−0.02 (−1.73)

1.25 (−0.52)

1.01 (−0.75)

0.42 (−1.31)

−0.26 (−1.97)

0.30 (−1.43)

0.69 (−1.07)

EBGM新增

1.12 (0.93)

1.39 (1.10)

0.56 (0.41)

2.88 (1.64)

1.66 (1.02)

1.62 (0.98)

2.22 (1.17)

0.62 (0.38)

2.93 (1.14)

1.10 (0.60)

1.17 (0.63)

0.99 (0.53)

2.38 (1.02)

2.01 (0.90)

1.34 (0.67)

0.84 (0.43)

1.23 (0.60)

Reproductive System and Breast Disorders

Vaginal haemorrhage

0.83 (0.48,1.45)

0.83 (0.41)

−0.20 (−1.90)

0.87 (0.50)

Vascular disorders

Hypertension

Hypotension

Blood pressure fluctuation

0.76 (0.64,0.89)

0.63 (0.43,0.94)

1.41 (0.83,2.39)

0.76 (10.94)

0.63 (5.25)

1.41 (1.61)

−0.30 (−1.97)

−0.52 (−2.20)

0.35 (−1.35)

0.81 (0.69)

0.70 (0.47)

1.28 (0.75)

Blood and Lymphatic System Disorders

Thrombocytopenia

Anaemia

Neutropenia

Lymphadenopathy

0.74 (0.51,1.08)

0.43 (0.29,0.65)

0.39 (0.21,0.73)

2.75 (1.17,6.48) *

0.74 (2.51)

0.44 (17.91)

0.39 (9.24)

2.75 (5.84) *

−0.34 (−2.02)

−0.98 (−2.66)

−1.12 (−2.81)

0.94 (−0.84)

0.79 (0.54)

0.51 (0.34)

0.46 (0.25)

1.92 (0.81)

Eye disorders

Visual impairment

Vision blurred

1.37 (1.06,1.76) *

1.36 (5.75)

0.32 (−1.35)

1.25 (0.97)

Cardiac disorders

Cardiac disorder

Myocarditis

1.59 (0.76,3.29)

0.44 (0.23,0.85)

1.58 (1.56)

0.44 (6.30)

0.47 (−1.27)

−0.97 (−2.67)

1.38 (0.67)

0.51 (0.26)

Psychiatric disorders

Insomnia

Confusional state

Anxiety

1.02 (0.64,1.64)

0.60 (0.35,1.02)

0.73 (0.40,1.33)

1.02 (0.01)

0.60 (3.63)

0.73 (1.07)

0.02 (−1.67)

−0.59 (−2.28)

−0.36 (−2.06)

1.02 (0.63)

0.66 (0.39)

0.78 (0.43)