Safety and Efficacy of Treatment with/without Ramucirumab in Advanced or Metastatic Cancer: A Meta-Analysis of 11 Global, Double-Blind, Phase 3 Randomized Controlled Trials
Table 3
Meta analysis of TEAEs of special interest.
TEAEs of special interest
Studies, n
RAM, n
Con, n
OR (95% CI)
value
Events
Total
Events
Total
Bleeding/haemorrhage
10
Grade 1-2
1304
3782
503
3028
2.72 [2.41, 3.07]
<0.00001
Grade ≧3
107
3782
87
3028
1.02 [0.76, 1.37]
0.89
Hypertension
10
Grade 1-2
600
3782
190
3028
2.57 [2.16, 3.05]
<0.00001
Grade ≧3
379
3782
88
3028
3.86 [3.04, 4.89]
<0.00001
Proteinuria
10
Grade 1-2
486
3782
153
3028
2.94 [2.42, 3.57]
<0.00001
Grade ≧3
55
3782
4
3028
6.46 [3.03, 13.78]
<0.00001
CHF
9
Grade 1-2
25
3546
12
2913
1.59 [0.80, 3.15]
0.19
Grade ≧3
19
3546
9
2913
1.62 [0.78, 3.37]
0.20
Liver injury/failure
5
Grade 1-2
361
1623
170
1373
1.73 [1.40, 2.15]
<0.00001
Grade ≧3
155
1623
125
1373
1.01 [0.78, 1.31]
0.92
IRR
10
Grade 1-2
216
3717
118
2978
1.59 [0.86, 2.93]
0.06
Grade ≧3
31
3717
13
2978
1.59 [0.86, 2.93]
0.14
VTE
10
Grade 1-2
111
3782
132
3028
0.68 [0.53, 0.89]
0.004
Grade ≧3
79
3782
90
3028
0.76 [0.56, 1.03]
0.07
ATE
10
Grade 1-2
44
3782
37
3028
0.97 [0.62, 1.50]
0.88
Grade ≧3
30
3782
29
3028
0.85 [0.51, 1.42]
0.54
GI perforation
8
Grade 1-2
11
2753
5
2370
1.61 [0.62, 4.17]
0.33
Grade ≧3
35
2753
9
2370
3.24 [1.60, 6.57]
0.001
GI haemorrhage
10
Grade 1-2
174
3288
85
2911
1.88 [1.44, 2.46]
<0.00001
Grade ≧3
66
3288
49
2911
1.17 [0.80, 1.70]
0.42
Renal failure
5
Grade 1-2
55
2018
54
2016
1.02 [0.69, 1.49]
0.94
Grade ≧3
23
2018
13
2016
1.75 [0.89, 3.43]
0.10
Epistaxis
4
Grade 1-2
393
1574
149
1466
3.19 [2.59, 3.92]
<0.00001
Grade ≧3
3
1574
1
1466
1.77 [0.26, 12.18]
0.56
Fistula
5
Grade 1-2
5
1270
1
895
1.51 [0.35, 6.50]
0.58
Grade ≧3
5
1270
1
895
1.87 [0.45, 7.87]
0.39
Healing complication
4
Grade 1-2
5
1114
2
961
2.00 [0.50, 8.02]
0.33
Grade ≧3
1
1114
0
961
2.93 [0.12, 72.32]
0.51
Pulmonary haemorrhage
5
Grade 1-2
75
1645
52
1529
1.43 [0.99, 2.05]
0.06
Grade ≧3
11
1645
11
1529
0.93 [0.42, 2.07]
0.87
TEAEs = treatment-emergent adverse events, RAM = ramucirumab, Con = control, OR = odds ratio, CI = confidence interval, CHF = congestive heart failure, IRR = infusion-related reaction, VTE = venous thromboembolic, ATE = arterial thromboembolic, and GI = gastrointestinal.
