Table 3. Adverse Events in a Study of the Effect of Co-trimoxazole vs Placebo on Death, Lung Transplant, or Hospital Admission in Patients With Idiopathic Pulmonary Fibrosis.

Adverse eventa	No. of events
	Co-trimoxazole	Placebo
Blood and lymphatic system disorders	3	3
Cardiac disorders	6	4
Ear and labyrinth disorders	3	0
Eye disorders	5	6
Gastrointestinal disorders	216	224
Nausea	89	67
Diarrhea	52	84
Vomiting	28	20
Constipation	11	5
General disorders and administration site conditions	36	20
Fatigue	15	11
Chest pain	8	6
Edema peripheral	5	0
Immune system disorders	1	1
Infections and infestations	110	127
Lower respiratory tract infection	63	66
Injury, poisoning, and procedural complications	7	10
Investigationsb	44	22
Weight decrease	24	16
Metabolism and nutrition disorders	57	27
Decreased appetite	26	9
Hyperkalemiac	24	14
Musculoskeletal and connective tissue disorders	21	20
Neoplasm/s benign, malignant, and unspecified (including cysts and polyps)	3	1
Nervous system disorders	41	32
Headache	22	14
Psychiatric disorders	5	2
Kidney and urinary disorders	14	7
Reproductive system and breast disorders	0	2
Respiratory, thoracic, and mediastinal disorders	77	95
Cough	27	33
Dyspnea	31	34
Skin and subcutaneous tissue disorders	46	30
Rash	31	20
Surgical and medical procedures	1	2
Vascular disorders	0	5
Total adverse events	696	640
≥1 adverse event, No. (%)	146 (86)	142 (83)
≥2 adverse events, No. (%)	119 (70)	121 (70)

^aAdverse events were captured at each study visit and coded using Medical Dictionary for Regulatory Activities terms.

^bInvestigations include abnormal laboratory results and weight change.

^cHyperkalemia was defined as a potassium greater than 5.0 mmol/L.