Adverse Reaction
(SMQ narrow, MedDRA 24.0)
|
No cases
|
ROR (-ROR)a
|
No cases
|
ROR (-ROR)
|
Torsade de Pointes / QT prolongation |
2 |
3.5 (0.9) |
39 |
132.8
(76.7) |
Cardiomyopathy |
9 |
25.5 (13.1) |
5 |
26.0 (9.1) |
Cardiac arrhythmias |
7 |
1.9 (0.9) |
51 |
20.3 (14.6) |
Drug related hepatic disorders - severe events only |
8 |
0.8 (0.4) |
103 |
18.7 (14.7) |
Hepatic disorders |
16 |
1.0 (0.6) |
135 |
17.1 (13.8) |
Dyslipidaemia |
0 |
NA |
10 |
12.1 (6.1) |
Shock |
8 |
1.1 (0.5) |
47 |
9.5 (6.9) |
Ischaemic colitis |
0 |
NA |
3 |
8.9 (2.6) |
Severe cutaneous adverse reactions |
15 |
3.2 (1.9) |
23 |
8.8
(5.6) |
Rhabdomyolysis/myopathy |
8 |
5.2 (2.6) |
5 |
8.0 (3.1) |
Haemolytic disorders |
3 |
3.6 (1.1) |
3 |
6.6 (2.0) |
Suicide/self-injury |
4 |
3.1 (1.2) |
6 |
5.9 (2.6) |
Cardiac failure |
3 |
1.6 (0.5) |
7 |
5.5 (2.5) |
Toxic-septic shock conditions |
2 |
2.8 (0.7) |
4 |
5.3
(1.9) |
Retinal disorders |
15 |
15.4 (9.2) |
7 |
5.1 (2.3) |
Chronic kidney disease |
2 |
1.6 (0.4) |
6 |
4.6 (2.0) |
Noninfectious encephalopathy/delirium |
1 |
0.6 (0.1) |
5 |
4.3
(1.7) |
Noninfectious meningitis |
3 |
4.5 (1.4) |
2 |
3.8 (0.9) |
Pulmonary hypertension |
3 |
13.0 (4.1) |
1 |
3.6 (0.5) |
Respiratory failure |
3 |
1.0 (0.3) |
7 |
3.4 (1.6) |
Acute renal failure |
4 |
0.7 (0.3) |
14 |
3.3 (1.9) |
Hearing impairment |
8 |
4.7 (2.3) |
5 |
3.2 (1.3) |
Gastrointestinal perforation, ulceration, haemorrhage or obstruction |
6 |
0.6 (0.3) |
14 |
2.7 (1.6) |
Sepsis |
4 |
3.3 (1.2) |
4 |
2.7 (1.0) |
Infective pneumonia |
7 |
3.1 (1.5) |
6 |
2.2 (1.0) |
Noninfectious diarrhoea |
12 |
0.6 (0.3) |
37 |
2.1 (1.5) |
Malignant lymphomas |
4 |
7.2 (2.7) |
1 |
1.7 (0.2) |
Haematopoietic cytopenias |
30 |
2.5 (1.7) |
14 |
1.2
(0.7) |
Ocular motility disorders |
3 |
4.4 (1.4) |
1 |
1.2 (0.2) |
Pregnancy and neonatal topics |
18 |
5.2 (3.2) |
5 |
1.2
(0.5) |
Agranulocytosis |
14 |
3.2 (1.9) |
4 |
1.1 (0.4) |
Opportunistic infections |
8 |
3.6 (1.8) |
3 |
1.0 (0.3) |
Malignancies |
11 |
2.3 (1.3) |
1 |
0.2 (0.0) |
Interstitial lung disease |
9 |
5.0 (2.6) |
0 |
NA |