Table 3. Safety Outcomes.^*.

Outcome	Doxycycline (N = 263)	Azithromycin (N = 261)	Combination Therapy (N =262)	All Patients (N =786)		P Value†
					Combination Therapy vs. Doxycycline	Combination Therapy vs. Azithromycin	Azithromycin vs. Doxycycline
	number of patients (percent)
Grade 3 or higher adverse event
Any	21(8)	29 (11)	29 (11)	79 (10)	0.24	1.00	0.24
Possibly treatment-related‡	0	0	1 (<1)§	1 (<1)	NA	NA	NA
Serious adverse event
Any	30 (11)	36 (14)	31 (12)	97 (12)	0.89	0.52	0.43
Death	27 (10)	30 (11)	31 (12)	88 (11)	0.58	1.00	0.68
Life-threatening event¶	3(1)	5(2)	0	8(1)	NA	NA	NA
Prolongation of hospitalization	0	1 (<1)	0	1 (<1)	NA	NA	NA
Any drug discontinuation	13(5)	17(7)	12 (5)	42 (5)	1.00	0.35	0.46

^*The safety population included all the patients who had received at least one dose of a trial drug. NA denotes not applicable.

^†P values were calculated with the use of Fisher’s exact test.

^‡The investigators made the determination regarding whether an adverse event was possibly related to a trial drug.

^§One patient had altered behavior and an episode of self-limiting generalized tonic-clonic seizures, which was considered to be possibly treatment-related. The patient recovered fully and survived.

^¶In the doxycycline group, one patient had a seizure and cardiac arrest, one had pulmonary edema, and one had severe hypotension. In the azithromycin group, three patients had respiratory failure, one patient had a cardiac arrest secondary to hypoxia, and one had hypotension, myocarditis, and acute respiratory distress syndrome.