Information regarding exposure to antibiotics according to centre and severe adverse events in the two intervention arms classified according to MedDRA preferred term and actions taken regarding the trial interventions

SJ Allen; K Wareham; D Wang; C Bradley; B Sewell; H Hutchings; W Harris; A Dhar; H Brown; A Foden; MB Gravenor; D Mack; CJ Phillips

NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.

Allen SJ, Wareham K, Wang D, et al. A high-dose preparation of lactobacilli and bifidobacteria in the prevention of antibiotic-associated and Clostridium difficile diarrhoea in older people admitted to hospital: a multicentre, randomised, double-blind, placebo-controlled, parallel arm trial (PLACIDE). Southampton (UK): NIHR Journals Library; 2013 Dec. (Health Technology Assessment, No. 17.57.)

Cover of A high-dose preparation of lactobacilli and bifidobacteria in the prevention of antibiotic-associated and Clostridium difficile diarrhoea in older people admitted to hospital: a multicentre, randomised, double-blind, placebo-controlled, parallel arm trial (PLACIDE)

A high-dose preparation of lactobacilli and bifidobacteria in the prevention of antibiotic-associated and Clostridium difficile diarrhoea in older people admitted to hospital: a multicentre, randomised, double-blind, placebo-controlled, parallel arm trial (PLACIDE).

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Appendix 9Information regarding exposure to antibiotics according to centre and severe adverse events in the two intervention arms classified according to MedDRA preferred term and actions taken regarding the trial interventions

TABLE 31

Antibiotic exposure according to centre. The number and percentage of participants who received therapy with the antibiotic during the period 7 days before recruitment to the end of follow-up at 8 weeks

Antibiotic (classes and drugs)	ABMUHB			CDDFT
Antibiotic (classes and drugs)	Singleton, n (%)	Morriston, n (%)	Princess of Wales, n (%)	Durham, n (%)	Darlington, n (%)
Penicillins	138 (68.0)	968 (65.4)	147 (77.0)	436 (79.7)	424 (81.4)
Benzylpenicillin	18 (8.9)	130 (8.8)	23 (12.0)	20 (3.7)	23 (4.4)
Penicillinase-resistant penicillin – flucloxacillin	29 (14.3)	372 (25.2)	68 (35.6)	83 (15.2)	80 (15.4)
Broad-spectrum penicillins	116 (57.1)	700 (47.3)	96 (50.3)	371 (67.8)	368 (70.6)
Amoxicillin	32 (15.8)	224 (15.1)	43 (22.5)	209 (38.2)	125 (24.0)
Ampicillin	0 (0.0)	1 (0.1)	0 (0.0)	0 (0.0)	2 (0.4)
Co-amoxiclav	97 (47.8)	559 (37.8)	68 (35.6)	227 (41.5)	284 (54.5)
Antipseudomonas penicillins	18 (8.9)	126 (8.5)	24 (12.6)	52 (9.5)	25 (4.8)
Piperacillin	0 (0.0)	0 (0.0)	0 (0.0)	2 (0.4)	1 (0.2)
Piperacillin plus tazobactam	18 (8.9)	126 (8.5)	24 (12.6)	51 (9.3)	24 (4.6)
Cephalosporins	59 (29.1)	602 (40.7)	26 (13.6)	18 (3.3)	10 (1.9)
First generation	10 (4.9)	113 (7.6)	6 (3.1)	15 (2.7)	7 (1.3)
Cefalexin	10 (4.9)	112 (7.6)	6 (3.1)	15 (2.7)	7 (1.3)
Cefradine	0 (0.0)	1 (0.1)	0 (0.0)	0 (0.0)	0 (0.0)
Second generation	52 (25.6)	517 (35.0)	22 (11.5)	3 (0.5)	0 (0.0)
Cefaclor	13 (6.4)	38 (2.6)	0 (0.0)	0 (0.0)	0 (0.0)
Cefixime	0 (0.0)	1 (0.1)	0 (0.0)	0 (0.0)	0 (0.0)
Cefuroxime	45 (22.2)	507 (34.3)	22 (11.5)	3 (0.5)	0 (0.0)
Third generation	2 (1.0)	16 (1.1)	0 (0.0)	0 (0.0)	3 (0.6)
Cefotaxime	1 (0.5)	2 (0.1)	0 (0.0)	0 (0.0)	0 (0.0)
Ceftazidime	0 (0.0)	11 (0.7)	0 (0.0)	0 (0.0)	3 (0.6)
Ceftriaxone	1 (0.5)	4 (0.3)	0 (0.0)	0 (0.0)	0 (0.0)
Other antibiotics	153 (75.4)	1036 (70.0)	138 (72.3)	332 (60.7)	295 (56.6)
Carbapenems and other beta-lactams	8 (3.9)	43 (2.9)	4 (2.1)	6 (1.1)	1 (0.2)
Ertapenem	0 (0.0)	0 (0.0)	0 (0.0)	1 (0.2)	0 (0.0)
Imipenem	0 (0.0)	5 (0.3)	0 (0.0)	0 (0.0)	0 (0.0)
Meropenem	8 (3.9)	39 (2.6)	4 (2.1)	5 (0.9)	1 (0.2)
Tetracyclines	36 (17.7)	235 (15.9)	26 (13.6)	74 (13.5)	62 (11.9)
Demeclocycline	0 (0.0)	2 (0.1)	0 (0.0)	0 (0.0)	0 (0.0)
Doxycycline	36 (17.7)	226 (15.3)	26 (13.6)	69 (12.6)	55 (10.6)
Lymecycline	0 (0.0)	1 (0.1)	0 (0.0)	0 (0.0)	0 (0.0)
Oxytetracycline	0 (0.0)	4 (0.3)	0 (0.0)	6 (1.1)	4 (0.8)
Tetracycline	0 (0.0)	2 (0.1)	0 (0.0)	1 (0.2)	3 (0.6)
Aminoglycosides	7 (3.4)	271 (18.3)	28 (14.7)	16 (2.9)	56 (10.7)
Gentamicin	6 (3.0)	271 (18.3)	28 (14.7)	16 (2.9)	56 (10.7)
Tobramycin	1 (0.5)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)
Macrolides	45 (22.2)	144 (9.7)	34 (17.8)	152 (27.8)	125 (24.0)
Azithromycin	0 (0.0)	2 (0.1)	4 (2.1)	9 (1.6)	9 (1.7)
Clarithromycin	39 (19.2)	98 (6.6)	26 (13.6)	137 (25.0)	113 (21.7)
Erythromycin	9 (4.4)	52 (3.5)	5 (2.6)	12 (2.2)	6 (1.2)
Clindamycin	2 (1.0)	16 (1.1)	1 (0.5)	2 (0.4)	11 (2.1)
Sulphonamides and trimethoprim	40 (19.7)	267 (18.1)	30 (15.7)	88 (16.1)	45 (8.6)
Co-trimoxazole	0 (0.0)	5 (0.3)	0 (0.0)	1 (0.2)	0 (0.0)
Trimethoprim	40 (19.7)	262 (17.7)	30 (15.7)	87 (15.9)	45 (8.6)
Metronidazole	22 (10.8)	217 (14.7)	21 (11.0)	30 (5.5)	23 (4.4)
Quinolones	43 (21.2)	229 (15.5)	16 (8.4)	41 (7.5)	36 (6.9)
Ciprofloxacin	38 (18.7)	224 (15.1)	15 (7.9)	31 (5.7)	20 (3.8)
Levofloxacin	5 (2.5)	7 (0.5)	1 (0.5)	11 (2.0)	11 (2.1)
Moxifloxacin	0 (0.0)	0 (0.0)	0 (0.0)	2 (0.4)	5 (1.0)
Norfloxacin	1 (0.5)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)
Glycopeptides	6 (3.0)	133 (9.0)	9 (4.7)	11 (2.0)	19 (3.6)
Teicoplanin	4 (2.0)	102 (6.9)	8 (4.2)	11 (2.0)	18 (3.5)
Vancomycin	2 (1.0)	43 (2.9)	1 (0.5)	0 (0.0)	1 (0.2)
TB drugs	1 (0.5)	31 (2.1)	3 (1.6)	6 (1.1)	5 (1.0)
Ethambutol	0 (0.0)	0 (0.0)	2 (1.0)	1 (0.2)	0 (0.0)
Rifampicin	1 (0.5)	31 (2.1)	3 (1.6)	6 (1.1)	5 (1.0)
Streptomycin	0 (0.0)	1 (0.1)	0 (0.0)	0 (0.0)	0 (0.0)
Others	5 (2.5)	56 (3.8)	8 (4.2)	17 (3.1)	5 (1.0)
Daptomycin	0 (0.0)	1 (0.1)	0 (0.0)	0 (0.0)	0 (0.0)
Linezolid	0 (0.0)	2 (0.1)	1 (0.5)	0 (0.0)	0 (0.0)
Nitrofurantoin	5 (2.5)	41 (2.8)	4 (2.1)	17 (3.1)	4 (0.8)
Sodium fusidate	0 (0.0)	12 (0.8)	4 (2.1)	0 (0.0)	1 (0.2)

TABLE 32

Serious adverse events classified according to MedDRA PT, severity classification and intervention arm^a

PT	Probiotic (N = 1470), n (%)^b	Placebo (N = 1471), n (%)^b	Total (N = 2941), n (%)^b
SAE resulted in death	79 (5.4)	64 (4.4)	143 (4.9)
Pneumonia	15 (1.0)	12 (0.8)	27 (0.9)
General physical health deterioration	10 (0.7)	6 (0.4)	16 (0.5)
Obstructive airways disorder	9 (0.6)	7 (0.5)	16 (0.5)
Lung neoplasm malignant	3 (0.2)	5 (0.3)	8 (0.3)
Cardiac failure	4 (0.3)	3 (0.2)	7 (0.2)
Cerebrovascular accident	4 (0.3)	3 (0.2)	7 (0.2)
Metastatic neoplasm	2 (0.1)	3 (0.2)	5 (0.2)
Sepsis	3 (0.2)	2 (0.1)	5 (0.2)
Cardiac arrest	2 (0.1)	2 (0.1)	4 (0.1)
Pleural effusion	2 (0.1)	1 (0.1)	3 (0.1)
Cardiac failure congestive	2 (0.1)	1 (0.1)	3 (0.1)
Elderly	2 (0.1)	1 (0.1)	3 (0.1)
Myocardial infarction	1 (0.1)	2 (0.1)	3 (0.1)
Pulmonary embolism	1 (0.1)	2 (0.1)	3 (0.1)
Renal failure chronic	2 (0.1)	1 (0.1)	3 (0.1)
Respiratory failure	2 (0.1)	1 (0.1)	3 (0.1)
Urinary tract infection	0 (0.0)	3 (0.2)	3 (0.1)
Gastrointestinal haemorrhage	2 (0.1)	0 (0.0)	2 (0.1)
Peptic ulcer perforation	1 (0.1)	0 (0.0)	1 (0.0)
Renal failure	0 (0.0)	2 (0.1)	2 (0.1)
Aortic aneurysm rupture	0 (0.0)	1 (0.1)	1 (0.0)
Bacterial sepsis	0 (0.0)	1 (0.1)	1 (0.0)
Bladder cancer	1 (0.1)	0 (0.0)	1 (0.0)
Bladder neoplasm	1 (0.1)	0 (0.0)	1 (0.0)
Bronchiectasis	0 (0.0)	1 (0.1)	1 (0.0)
Cardiac death	1 (0.1)	0 (0.0)	1 (0.0)
Chronic renal failure	1 (0.1)	0 (0.0)	1 (0.0)
Creutzfeldt–Jakob disease	1 (0.1)	0 (0.0)	1 (0.0)
Dementia	1 (0.1)	0 (0.0)	1 (0.0)
Diverticulitis	1 (0.1)	0 (0.0)	1 (0.0)
Duodenal ulcer perforation	0 (0.0)	1 (0.1)	1 (0.0)
Hiatus hernia, obstructive	0 (0.0)	1 (0.1)	1 (0.0)
Hyponatraemia	0 (0.0)	1 (0.1)	1 (0.0)
Implant site infection	1 (0.1)	0 (0.0)	1 (0.0)
Ischaemic heart disease	1 (0.1)	0 (0.0)	1 (0.0)
Left ventricular failure	0 (0.0)	1 (0.1)	1 (0.0)
Lower gastrointestinal haemorrhage	1 (0.1)	0 (0.0)	1 (0.0)
Lung infection – pseudomonal	1 (0.1)	0 (0.0)	1 (0.0)
Pleural neoplasm	1 (0.1)	0 (0.0)	1 (0.0)
Pulmonary fibrosis	0 (0.0)	1 (0.1)	1 (0.0)
Pulmonary oedema	0 (0.0)	1 (0.1)	1 (0.0)
Insufficient details to classify	1 (0.1)	0 (0.0)	1 (0.0)
SAE was life-threatening	6 (0.4)	5 (0.3)	11 (0.4)
Cardiac arrest	1 (0.1)	2 (0.1)	3 (0.1)
Acute renal failure	1 (0.1)	0 (0.0)	1 (0.0)
Gastric cancer	1 (0.1)	0 (0.0)	1 (0.0)
Lung neoplasm malignant	0 (0.0)	1 (0.1)	1 (0.0)
Metastatic neoplasm	0 (0.0)	1 (0.1)	1 (0.0)
Pulmonary oedema	1 (0.1)	0 (0.0)	1 (0.0)
Sepsis	1 (0.1)	0 (0.0)	1 (0.0)
Small intestinal obstruction	1 (0.1)	0 (0.0)	1 (0.0)
Subdural haemorrhage	0 (0.0)	1 (0.1)	1 (0.0)
SAE prolonged or required hospitalisation	222 (15.1)	223 (15.2)	445 (15.1)
Pneumonia	35 (2.4)	38 (2.6)	73 (2.5)
Obstructive airways disorder	17 (1.2)	15 (1.0)	32 (1.1)
Fall	18 (1.2)	13 (0.9)	31 (1.1)
Urinary tract infection	14 (1.0)	9 (0.6)	23 (0.8)
Cerebrovascular accident	6 (0.4)	10 (0.7)	16 (0.5)
Wound infection	5 (0.3)	7 (0.5)	12 (0.4)
Cellulitis	10 (0.7)	2 (0.1)	12 (0.4)
Lower gastrointestinal haemorrhage	3 (0.2)	7 (0.5)	10 (0.3)
Sepsis	4 (0.3)	6 (0.4)	10 (0.3)
Cardiac failure congestive	6 (0.4)	3 (0.2)	9 (0.3)
Abdominal pain	4 (0.3)	3 (0.2)	7 (0.2)
Anaemia	5 (0.3)	3 (0.2)	8 (0.3)
Myocardial infarction	7 (0.5)	1 (0.1)	8 (0.3)
Angina pectoris	4 (0.3)	3 (0.2)	7 (0.2)
Cardiac failure	3 (0.2)	4 (0.3)	7 (0.2)
Dyspnoea	4 (0.3)	3 (0.2)	7 (0.2)
Gastrointestinal haemorrhage	4 (0.3)	2 (0.1)	6 (0.2)
Pleural effusion	1 (0.1)	4 (0.3)	5 (0.2)
Viral infection	3 (0.2)	3 (0.2)	6 (0.2)
Bacterial sepsis	2 (0.1)	3 (0.2)	5 (0.2)
Chest pain	4 (0.3)	1 (0.1)	5 (0.2)
Cholecystitis	2 (0.1)	2 (0.1)	4 (0.1)
Cholelithiasis	4 (0.3)	1 (0.1)	5 (0.2)
Gastroenteritis	3 (0.2)	2 (0.1)	5 (0.2)
Joint dislocation reduction	2 (0.1)	2 (0.1)	4 (0.1)
Lung infection – pseudomonal	1 (0.1)	3 (0.2)	4 (0.1)
Urinary retention	1 (0.1)	3 (0.2)	4 (0.1)
Diverticulitis	4 (0.3)	0 (0.0)	4 (0.1)
Drug hypersensitivity	0 (0.0)	4 (0.3)	4 (0.1)
Haemorrhagic diathesis	1 (0.1)	2 (0.1)	3 (0.1)
Pulmonary oedema	2 (0.1)	2 (0.1)	4 (0.1)
Constipation	1 (0.1)	2 (0.1)	3 (0.1)
General physical health deterioration	2 (0.1)	1 (0.1)	3 (0.1)
Pulmonary embolism	1 (0.1)	2 (0.1)	3 (0.1)
Renal failure	1 (0.1)	1 (0.1)	2 (0.1)
Upper gastrointestinal haemorrhage	3 (0.2)	0 (0.0)	3 (0.1)
Acute coronary syndrome	0 (0.0)	2 (0.1)	2 (0.1)
Arrhythmia	2 (0.1)	0 (0.0)	2 (0.1)
Bladder catheter management	0 (0.0)	2 (0.1)	2 (0.1)
Convulsion	2 (0.1)	0 (0.0)	2 (0.1)
Decubitus ulcer	0 (0.0)	2 (0.1)	2 (0.1)
Deep-vein thrombosis postoperative	1 (0.1)	1 (0.1)	2 (0.1)
Dehydration	0 (0.0)	2 (0.1)	2 (0.1)
Haematoma	2 (0.1)	0 (0.0)	2 (0.1)
Haematuria	0 (0.0)	2 (0.1)	2 (0.1)
Hepatic cirrhosis	1 (0.1)	1 (0.1)	2 (0.1)
Hypercalcaemia	0 (0.0)	1 (0.1)	1 (0.0)
Ischaemic heart disease	1 (0.1)	1 (0.1)	2 (0.1)
Metastatic neoplasm	2 (0.1)	0 (0.0)	2 (0.1)
Oesophageal neoplasm	1 (0.1)	0 (0.0)	1 (0.0)
Organ failure	1 (0.1)	1 (0.1)	2 (0.1)
Pulmonary fibrosis	0 (0.0)	2 (0.1)	2 (0.1)
Pyelonephritis	0 (0.0)	2 (0.1)	2 (0.1)
Social problem	2 (0.1)	0 (0.0)	2 (0.1)
Transient ischaemic attack	2 (0.1)	0 (0.0)	2 (0.1)
Upper respiratory tract infection	0 (0.0)	2 (0.1)	2 (0.1)
Wound dehiscence	0 (0.0)	2 (0.1)	2 (0.1)
Adverse drug reaction	0 (0.0)	1 (0.1)	1 (0.0)
Agitation	0 (0.0)	1 (0.1)	1 (0.0)
Anorectal varices haemorrhage	1 (0.1)	0 (0.0)	1 (0.0)
Aortic surgery	1 (0.1)	0 (0.0)	1 (0.0)
Appendiceal abscess	0 (0.0)	1 (0.1)	1 (0.0)
Arterial thrombosis limb	0 (0.0)	1 (0.1)	1 (0.0)
Arthritis infective	1 (0.1)	0 (0.0)	1 (0.0)
Atrial fibrillation	1 (0.1)	0 (0.0)	1 (0.0)
Bile duct T-tube removal	0 (0.0)	1 (0.1)	1 (0.0)
Bile duct stent removal	0 (0.0)	1 (0.1)	1 (0.0)
Bone trimming	0 (0.0)	1 (0.1)	1 (0.0)
Brain neoplasm	0 (0.0)	1 (0.1)	1 (0.0)
Bronchial fistula repair	1 (0.1)	0 (0.0)	1 (0.0)
Bronchospasm	1 (0.1)	0 (0.0)	1 (0.0)
Cardiac pacemaker replacement	0 (0.0)	1 (0.1)	1 (0.0)
Cardiac pacemaker revision	0 (0.0)	1 (0.1)	1 (0.0)
Cholecystectomy	1 (0.1)	0 (0.0)	1 (0.0)
Colostomy	0 (0.0)	1 (0.1)	1 (0.0)
Cystoscopy	1 (0.1)	0 (0.0)	1 (0.0)
Deep-vein thrombosis	0 (0.0)	1 (0.1)	1 (0.0)
Dementia	1 (0.1)	0 (0.0)	1 (0.0)
Diabetic foot infection	0 (0.0)	1 (0.1)	1 (0.0)
Dialysis related complication	1 (0.1)	0 (0.0)	1 (0.0)
Diarrhoea	0 (0.0)	1 (0.1)	1 (0.0)
Duodenal ulcer haemorrhage	1 (0.1)	0 (0.0)	1 (0.0)
Eating disorder	1 (0.1)	0 (0.0)	1 (0.0)
Eczema	1 (0.1)	0 (0.0)	1 (0.0)
Foreign-body aspiration	1 (0.1)	0 (0.0)	1 (0.0)
Gallbladder empyema	1 (0.1)	0 (0.0)	1 (0.0)
Gangrene	1 (0.1)	0 (0.0)	1 (0.0)
Gastroenteritis norovirus	0 (0.0)	1 (0.1)	1 (0.0)
Gastrointestinal examination	0 (0.0)	1 (0.1)	1 (0.0)
Groin abscess	1 (0.1)	0 (0.0)	1 (0.0)
Haematoma infection	1 (0.1)	0 (0.0)	1 (0.0)
Heart valve replacement	1 (0.1)	0 (0.0)	1 (0.0)
Herpes zoster ophthalmic	0 (0.0)	1 (0.1)	1 (0.0)
Hip fracture	0 (0.0)	1 (0.1)	1 (0.0)
Hyperkalaemia	1 (0.1)	0 (0.0)	1 (0.0)
Hypertension	1 (0.1)	0 (0.0)	1 (0.0)
Hypocalcaemia	1 (0.1)	0 (0.0)	1 (0.0)
Hypoglycaemia	0 (0.0)	1 (0.1)	1 (0.0)
Hypokalaemia	0 (0.0)	1 (0.1)	1 (0.0)
Hyponatraemia	0 (0.0)	1 (0.1)	1 (0.0)
Implant site infection	1 (0.1)	0 (0.0)	1 (0.0)
Infected bites	1 (0.1)	0 (0.0)	1 (0.0)
International normalised ratio abnormal	0 (0.0)	1 (0.1)	1 (0.0)
Intestinal polyp	1 (0.1)	0 (0.0)	1 (0.0)
Ischaemic limb pain	1 (0.1)	0 (0.0)	1 (0.0)
Joint injection	0 (0.0)	1 (0.1)	1 (0.0)
Joint surgery	1 (0.1)	0 (0.0)	1 (0.0)
Leg amputation	0 (0.0)	1 (0.1)	1 (0.0)
Limb crushing injury	0 (0.0)	1 (0.1)	1 (0.0)
Liver abscess	0 (0.0)	1 (0.1)	1 (0.0)
Lung neoplasm malignant	0 (0.0)	1 (0.1)	1 (0.0)
Malnutrition	0 (0.0)	1 (0.1)	1 (0.0)
Mediastinal abscess	0 (0.0)	1 (0.1)	1 (0.0)
Mouth haemorrhage	0 (0.0)	1 (0.1)	1 (0.0)
Multiple myeloma	1 (0.1)	0 (0.0)	1 (0.0)
Muscle swelling	0 (0.0)	1 (0.1)	1 (0.0)
Musculoskeletal chest pain	0 (0.0)	1 (0.1)	1 (0.0)
Myalgia	1 (0.1)	0 (0.0)	1 (0.0)
Nephrectomy	0 (0.0)	1 (0.1)	1 (0.0)
Nephrolithiasis	1 (0.1)	0 (0.0)	1 (0.0)
Non-Hodgkin’s lymphoma	1 (0.1)	0 (0.0)	1 (0.0)
Oesophagogastroscopy	1 (0.1)	0 (0.0)	1 (0.0)
Oral discharge	0 (0.0)	1 (0.1)	1 (0.0)
Otitis externa	1 (0.1)	0 (0.0)	1 (0.0)
Pain in extremity	1 (0.1)	0 (0.0)	1 (0.0)
Pancreatitis	0 (0.0)	1 (0.1)	1 (0.0)
Peptic ulcer haemorrhage	1 (0.1)	0 (0.0)	1 (0.0)
Peptic ulcer perforation	1 (0.1)	0 (0.0)	1 (0.0)
Peritonitis	1 (0.1)	0 (0.0)	1 (0.0)
Pneumonia aspiration	0 (0.0)	1 (0.1)	1 (0.0)
Pneumothorax	1 (0.1)	0 (0.0)	1 (0.0)
Renal failure chronic	0 (0.0)	1 (0.1)	1 (0.0)
Shunt infection	0 (0.0)	1 (0.1)	1 (0.0)
Skin graft infection	0 (0.0)	1 (0.1)	1 (0.0)
Skin ulcer	1 (0.1)	0 (0.0)	1 (0.0)
Supraventricular tachycardia	1 (0.1)	0 (0.0)	1 (0.0)
Syncope	0 (0.0)	1 (0.1)	1 (0.0)
Trigeminal neuralgia	0 (0.0)	1 (0.1)	1 (0.0)
Umbilical hernia, obstructive	0 (0.0)	1 (0.1)	1 (0.0)
Urethral stent insertion	0 (0.0)	1 (0.1)	1 (0.0)
Ventricular tachycardia	1 (0.1)	0 (0.0)	1 (0.0)
Viral upper respiratory tract infection	0 (0.0)	1 (0.1)	1 (0.0)
Volvulus	1 (0.1)	0 (0.0)	1 (0.0)
Wound complication	0 (0.0)	1 (0.1)	1 (0.0)
Wound haematoma	0 (0.0)	1 (0.1)	1 (0.0)
Wound infection	1 (0.1)	0 (0.0)	1 (0.0)
Insufficient details to classify	0 (0.0)	1 (0.1)	1 (0.0)
SAE resulted in persistent or significant disability or incapacity	2 (0.1)	2 (0.1)	4 (0.1)
Cerebrovascular accident	1 (0.1)	2 (0.1)	3 (0.1)
Urinary tract infection	1 (0.1)	0 (0.0)	1 (0.0)
Other significant medical event	6 (0.4)	5 (0.3)	11 (0.4)
Upper gastrointestinal haemorrhage	1 (0.1)	1 (0.1)	2 (0.1)
Cardiac failure	0 (0.0)	1 (0.1)	1 (0.0)
Cholelithiasis	1 (0.1)	0 (0.0)	1 (0.0)
Dysentery	1 (0.1)	0 (0.0)	1 (0.0)
Haemorrhoids	1 (0.1)	0 (0.0)	1 (0.0)
Incision site haematoma	0 (0.0)	1 (0.1)	1 (0.0)
Joint dislocation reduction	1 (0.1)	0 (0.0)	1 (0.0)
Lower gastrointestinal haemorrhage	1 (0.1)	0 (0.0)	1 (0.0)
Psoas abscess	0 (0.0)	1 (0.1)	1 (0.0)
Renal failure	0 (0.0)	1 (0.1)	1 (0.0)

a: Diagnoses for SAEs were based on all available clinical evidence. SAEs were classified according to an organ system wherever possible. For example, ‘cellulitis’ was classified as ‘skin and subcutaneous tissue disorders’ in preference to ‘infections and infestations’. SAEs were allocated to the most appropriate PT of the MedDRA.⁴²
b: Percentages represent the number of participants with at least one SAE divided by the number of participants in the treatment arm.

TABLE 33

Serious adverse events that resulted in the IMP being withdrawn or discontinued temporarily according to MedDRA PT^a and intervention arm

PT	Probiotic (N = 1470), n (%)^b	Placebo (N = 1471), n (%)^b	Total (N = 2941), n (%)^b
IMP withdrawn	8 (0.5)	6 (0.4)	14 (0.5)
Lower gastrointestinal haemorrhage	1 (0.1)	1 (0.1)	2 (0.1)
Pneumonia	2 (0.1)	0 (0.0)	2 (0.1)
Acute renal failure	1 (0.1)	0 (0.0)	1 (0.0)
Cerebrovascular accident	0 (0.0)	1 (0.1)	1 (0.0)
Cholelithiasis	1 (0.1)	0 (0.0)	1 (0.0)
Drug hypersensitivity	0 (0.0)	1 (0.1)	1 (0.0)
Duodenal ulcer perforation	0 (0.0)	1 (0.1)	1 (0.0)
Haemorrhagic diathesis	0 (0.0)	1 (0.1)	1 (0.0)
Metastatic neoplasm	0 (0.0)	1 (0.1)	1 (0.0)
Peptic ulcer perforation	1 (0.1)	0 (0.0)	1 (0.0)
Sepsis	1 (0.1)	0 (0.0)	1 (0.0)
Upper gastrointestinal haemorrhage	1 (0.1)	0 (0.0)	1 (0.0)
IMP withdrawn temporarily	44 (3.0)	46 (3.1)	90 (3.1)
Pneumonia	4 (0.3)	5 (0.3)	9 (0.3)
Urinary tract infection	3 (0.2)	3 (0.2)	6 (0.2)
Cerebrovascular accident	3 (0.2)	2 (0.1)	5 (0.2)
Obstructive airways disorder	3 (0.2)	2 (0.1)	5 (0.2)
Angina pectoris	2 (0.1)	2 (0.1)	4 (0.1)
Fall	1 (0.1)	3 (0.2)	4 (0.1)
Wound infection	1 (0.1)	3 (0.2)	4 (0.1)
Cholecystitis	1 (0.1)	1 (0.1)	2 (0.1)
Myocardial infarction	3 (0.2)	0 (0.0)	3 (0.1)
Viral infection	3 (0.2)	0 (0.0)	3 (0.1)
Abdominal pain	1 (0.1)	1 (0.1)	2 (0.1)
Bacterial sepsis	1 (0.1)	1 (0.1)	2 (0.1)
Cardiac arrest	0 (0.0)	2 (0.1)	2 (0.1)
Cellulitis	2 (0.1)	0 (0.0)	2 (0.1)
Gastrointestinal haemorrhage	2 (0.1)	0 (0.0)	2 (0.1)
Haematoma	2 (0.1)	0 (0.0)	2 (0.1)
Joint dislocation reduction	1 (0.1)	1 (0.1)	2 (0.1)
Lung infection – pseudomonal	1 (0.1)	1 (0.1)	2 (0.1)
Appendiceal abscess	0 (0.0)	1 (0.1)	1 (0.0)
Bronchospasm	1 (0.1)	0 (0.0)	1 (0.0)
Cardiac pacemaker revision	0 (0.0)	1 (0.1)	1 (0.0)
Chest pain	1 (0.1)	0 (0.0)	1 (0.0)
Cholelithiasis	1 (0.1)	0 (0.0)	1 (0.0)
Deep-vein thrombosis postoperative	1 (0.1)	0 (0.0)	1 (0.0)
Diabetic foot infection	0 (0.0)	1 (0.1)	1 (0.0)
Diverticulitis	1 (0.1)	0 (0.0)	1 (0.0)
Dysentery	1 (0.1)	0 (0.0)	1 (0.0)
Gastroenteritis	1 (0.1)	0 (0.0)	1 (0.0)
Hepatic cirrhosis	0 (0.0)	1 (0.1)	1 (0.0)
Incision site haematoma	0 (0.0)	1 (0.1)	1 (0.0)
International normalised ratio abnormal	0 (0.0)	1 (0.1)	1 (0.0)
Ischaemic limb pain	1 (0.1)	0 (0.0)	1 (0.0)
Joint injection	0 (0.0)	1 (0.1)	1 (0.0)
Leg amputation	0 (0.0)	1 (0.1)	1 (0.0)
Lower gastrointestinal haemorrhage	0 (0.0)	1 (0.1)	1 (0.0)
Nephrectomy	0 (0.0)	1 (0.1)	1 (0.0)
Pain in extremity	1 (0.1)	0 (0.0)	1 (0.0)
Pneumonia aspiration	0 (0.0)	1 (0.1)	1 (0.0)
Psoas abscess	0 (0.0)	1 (0.1)	1 (0.0)
Pulmonary embolism	0 (0.0)	1 (0.1)	1 (0.0)
Pulmonary oedema	1 (0.1)	0 (0.0)	1 (0.0)
Sepsis	0 (0.0)	1 (0.1)	1 (0.0)
Shunt infection	0 (0.0)	1 (0.1)	1 (0.0)
Skin graft infection	0 (0.0)	1 (0.1)	1 (0.0)
Small intestinal obstruction	1 (0.1)	0 (0.0)	1 (0.0)
Upper gastrointestinal haemorrhage	1 (0.1)	0 (0.0)	1 (0.0)
Upper respiratory tract infection	0 (0.0)	1 (0.1)	1 (0.0)
Viral upper respiratory tract infection	0 (0.0)	1 (0.1)	1 (0.0)
Wound dehiscence	0 (0.0)	1 (0.1)	1 (0.0)
Wound haematoma	0 (0.0)	1 (0.1)	1 (0.0)

a: Diagnoses for SAEs were based on all available clinical evidence. SAEs were classified according to an organ system wherever possible. For example, ‘cellulitis’ was classified as ‘skin and subcutaneous tissue disorders’ in preference to ‘infections and infestations’. SAEs were allocated to the most appropriate PT of the MedDRA.⁴²
b: Percentages represent the number of participants with at least one SAE divided by the number of participants in the treatment arm.

Copyright © Queen’s Printer and Controller of HMSO 2013. This work was produced by Allen et al. under the terms of a commissioning contract issued by the Secretary of State for Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK.

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Allen SJ, Wareham K, Wang D, et al. A high-dose preparation of lactobacilli and bifidobacteria in the prevention of antibiotic-associated and Clostridium difficile diarrhoea in older people admitted to hospital: a multicentre, randomised, double-blind, placebo-controlled, parallel arm trial (PLACIDE). Southampton (UK): NIHR Journals Library; 2013 Dec. (Health Technology Assessment, No. 17.57.) Appendix 9, Information regarding exposure to antibiotics according to centre and severe adverse events in the two intervention arms classified according to MedDRA preferred term and actions taken regarding the trial interventions.
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