Efficacy and Tolerability of Fixed-Dose Combination of Dexketoprofen and Dicyclomine Injection in Acute Renal Colic

Table 3

Adverse events (ITT analysis).

Adverse event	(DXD); % (𝑛) (𝑛=109)	(DLD); % (𝑛) (𝑛=108)	𝑃 value*
Total no. of patients	11.93(13)	12.04 (13)	1.00
Burning micturition	2.75 (3)	0.93 (1)	0.62
Pain at injection site	2.75 (3)	0 (0)	0.25
Headache	1.83 (2)	0.93 (1)	1.00
Nausea	1.83 (2)	7.40(8)	0.06
Dryness of mouth	1.83 (2)	0 (0)	0.5
Generalised weakness	1.83 (2)	0.93 (1)	1.00
Giddiness	0.92 (1)	0.93 (1)	1.00
Weakness	0.92 (1)	0(0)	1.00
Cough	0 (0)	0.93 (1)	0.5
Vomiting	0 (0)	4.63 (5)	0.03

*Fisher’s exact test ITT: Intention to treat.