Organ system

AL

DHPP

ASAQc

ASAQf

ASAQl

AQSP^†

ASMQ

ASSP

Cardiovascular

Palpitation

6

(0.7)*

3

(2.5)*

Central nervous system

Headache

429

(47.8)

270

(54.7)

70

(57.1)

2

(2.2)

66

(8.3)

67

(121.4)

5

(6.66)

Dizziness

67

(7.5)

23

(4.6)

33

(29.9)

32

(12.9)

57

(61.4)

18

(32.6)

6

(8)

Gastrointestinal

Anorexia

380

(42.3)

344

(69.7)

43

(35.1)

116

(46.8)

56

(60.3)

90

(11.3)

2

(2.66)

Abdominal pain

425

(65.9)

367

(74.3)

106

(86.5)

23

(9.3)

84

(90.4)

113

(14.2)

24

(43.5)

9

(12)

Vomiting, nausea

592

(65.9)

360

(72.9)

134

(109.3)

197

(79.5)

131

(141.0)

105

(13.2)

60

(108.7)

69

(92)

Diarrhoea

445

(49.6)

424

(85.9)

16

(13.0)

136

(54.9)

27

(29.1)

47

(5.9)

3

(5.4)

General

Weakness

256

(47.3)

54

(10.9)

5

(4.1)

4

(1.6)

43

(46.3)

75

(9.4)

145

(262.7)

Haematological

Anaemia D7

513

(57.1)

112

(22.7)

107

(87.3)

125

(50.4)

11

(11.8)

57

(7.2)

191

(346.0)

Haematological

Anaemia > D7

141

(15.7)

158

(32.0)

143

(57.7)

93

(100.1)

Others

Drug_related_AE

23

(2.6)*

4

(0.8)*

36

(14.5)

Drowsiness

12

(1.3)

5

(4.1)

14

(5.6)

13

(14.)

2

(0.2)

Asthenia

177

(19.7)

153

(31.0)

107

(87.3)

39

(15.7)

Respiratory

Cough

1087

(121.1)

1155

(233.9)

40

(32.6)

346

(139.6)

78

(84.0)

162

(20.4)

16

(21.33)

Skin and appendages

Pruritus

51

(5.7)

34

(6.9)

16

(13.0)

49

(19.8)

8

(8.6)

48

(6.0)

5

(9.0)

Rash

42

(4.7)

86

(17.4)

1

(0.8)

18

(7.26)

8

(8.6)

Total studies with treatment arm

41

15

5

10

9

5

3

2

Studies with/without AL and the treatment group

5

4

3

1

Total sample size

8979

4938

1226

2478

929

793

552

750