Table 5. Adverse events in the blinded... | Rockefeller University Press

Table 5.

Adverse events in the blinded phase and the extension phase

System organ class	Adverse events	Blinded phase		Extension phase
System organ class	Adverse events	Thalidomide (n = 3)	Placebo (n = 5)	All (n = 8)
Gastrointestinal disorders	Gastritis	1 (33.3%)	1 (20.0%)	1 (12.5%)
	Stomatitis	0	1 (20.0%)	0
	Diarrhea	0	0	1 (12.5%)
	Hemorrhoid	0	0	1 (12.5%)
General disorders and administration site conditions	Fever	0	1 (20.0%)	1 (12.5%)
Infections	Upper respiratory tract viral infection	1 (33.3%)	0	0
	Viral gastroenteritis	1 (33.3%)	0	0
	Aspergillosis	1 (33.3%)	0	0
	Otitis media	1 (33.3%)	0	0
	Pustular eczema	1 (33.3%)	0	0
	Thymic abscess	0	1 (20.0%)	0
	Respiratory syncytial virus infection	0	0	1 (12.5%)
	Clostridium difficile infection	0	0	1 (12.5%)
	Pharyngitis	0	0	1 (12.5%)
	Balanoposthitis	0	0	1 (12.5%)
	Infectious enteritis	0	0	1 (12.5%)
	Esophageal candidiasis	0	0	1 (12.5%)
	Perirectal abscess	0	0	1 (12.5%)
Hepatobiliary disorders	Liver dysfunction	3 (100.0%)	0	0
Musculoskeletal and connective tissue disorders	Muscular pain	1 (33.3%)	0	0
Musculoskeletal and connective tissue disorders	Backache	0	0	1 (12.5%)
Blood and lymphatic system disorders	Anemia	0	2 (40.0%)	3 (37.5%)
Blood and lymphatic system disorders	Lymphadenitis	1 (33.3%)	0	1 (12.5%)
Injury, poisoning, and procedural complications	Arthropod sting	1 (33.3%)	0	0
	Insect bite and sting	1 (33.3%)	0	0
	Redness of catheterization skin	0	0	1 (12.5%)
Nervous system disorder	Drowsiness	1 (33.3%)	0	0
Nervous system disorder	Febrile convulsion	1 (33.3%)	0	0
Skin and subcutaneous tissue disorders	Erythema	1 (33.3%)	0	1 (12.5%)
	Rash	1 (33.3%)	1 (20.0%)	1 (12.5%)
	Urticaria	1 (33.3%)	0	0
Immune system disorders	Anaphylactic reaction	0	1 (20.0%)	0
Immune system disorders	Allergy	0	0	1 (12.5%)
Investigations	Coagulation disorder	1 (33.3%)	0	0
	C-reactive protein increase	1 (33.3%)
	Aspartate aminotransferase increase	0	0	2 (25.0%)
	Alanine aminotransferase increase	0	0	1 (12.5%)

System organ class	Adverse events	Blinded phase		Extension phase
System organ class	Adverse events	Thalidomide (n = 3)	Placebo (n = 5)	All (n = 8)
Gastrointestinal disorders	Gastritis	1 (33.3%)	1 (20.0%)	1 (12.5%)
	Stomatitis	0	1 (20.0%)	0
	Diarrhea	0	0	1 (12.5%)
	Hemorrhoid	0	0	1 (12.5%)
General disorders and administration site conditions	Fever	0	1 (20.0%)	1 (12.5%)
Infections	Upper respiratory tract viral infection	1 (33.3%)	0	0
	Viral gastroenteritis	1 (33.3%)	0	0
	Aspergillosis	1 (33.3%)	0	0
	Otitis media	1 (33.3%)	0	0
	Pustular eczema	1 (33.3%)	0	0
	Thymic abscess	0	1 (20.0%)	0
	Respiratory syncytial virus infection	0	0	1 (12.5%)
	Clostridium difficile infection	0	0	1 (12.5%)
	Pharyngitis	0	0	1 (12.5%)
	Balanoposthitis	0	0	1 (12.5%)
	Infectious enteritis	0	0	1 (12.5%)
	Esophageal candidiasis	0	0	1 (12.5%)
	Perirectal abscess	0	0	1 (12.5%)
Hepatobiliary disorders	Liver dysfunction	3 (100.0%)	0	0
Musculoskeletal and connective tissue disorders	Muscular pain	1 (33.3%)	0	0
Musculoskeletal and connective tissue disorders	Backache	0	0	1 (12.5%)
Blood and lymphatic system disorders	Anemia	0	2 (40.0%)	3 (37.5%)
Blood and lymphatic system disorders	Lymphadenitis	1 (33.3%)	0	1 (12.5%)
Injury, poisoning, and procedural complications	Arthropod sting	1 (33.3%)	0	0
	Insect bite and sting	1 (33.3%)	0	0
	Redness of catheterization skin	0	0	1 (12.5%)
Nervous system disorder	Drowsiness	1 (33.3%)	0	0
Nervous system disorder	Febrile convulsion	1 (33.3%)	0	0
Skin and subcutaneous tissue disorders	Erythema	1 (33.3%)	0	1 (12.5%)
	Rash	1 (33.3%)	1 (20.0%)	1 (12.5%)
	Urticaria	1 (33.3%)	0	0
Immune system disorders	Anaphylactic reaction	0	1 (20.0%)	0
Immune system disorders	Allergy	0	0	1 (12.5%)
Investigations	Coagulation disorder	1 (33.3%)	0	0
	C-reactive protein increase	1 (33.3%)
	Aspartate aminotransferase increase	0	0	2 (25.0%)
	Alanine aminotransferase increase	0	0	1 (12.5%)

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