Table 7. Details of adverse events.

Event	Variable, ribavirin	Variable, no ribavirin	Fixed, ribavirin	Fixed, no ribavirin	Total Events
SAEs
Accidental drug overdose *	1	0	0	0	1
Acute appendicitis	0	0	0	1	1
Adenocarcinoma in lower third of oesophagus *	0	0	0	1	1
Burn to foot - degree unknown	1	0	0	0	1
Liver abscess	1	0	0	0	1
Lower respiratory tract infection - pneumonia	1	0	0	0	1
Musculoskeletal pain in chest radiating to left arm	0	0	0	1	1
Pericarditis	1	0	0	0	1
R epididymo-orchitis	0	0	0	1	1
Urinary sepsis	0	0	0	1	1
Severe AEs
Abscess leg	01	0	0	0	1
Alcohol intoxication acute	0	0	0	1	1
Anaemia	2	0	0	0	2
Cellulitis of leg	0	1	1	0	2
Concentration loss	1	0	0	0	1
Haemoglobin low	1	0	0	0	1
Hyperbilirubinemia	0	1	0	0	1
Inguinal hernia	1	0	0	0	1
Insomnia	3	0	0	0	3
Jaundice	0	0	0	1	1
Lethargic	1	0	0	0	1
Low mood	1	0	0	0	1
Pyelonephritis	0	0	1	0	1
Sores mouth	1	0	0	0	1
Suicidal ideation	1	0	0	0	1
Syncope	0	0	0	1	1
Tinnitus	1	0	0	0	1
AEs probably/definitely related to trial drugs
Anaemia	2	0	0	0	2
Concentration loss	1	0	0	0	1
Haemoglobin low	1	0	0	0	1
Hyperbilirubinemia	0	1	0	0	1
Insomnia	3	0	0	0	3
Jaundice	0	0	0	1	1
Lethargic	1	0	0	0	1
Low mood	1	0	0	0	1
Syncope	0	0	0	1	1
Tinnitus	1	0	0	0	1
Drug changes due to AEs
Anaemia	3	3	0	0	6
Concentration loss	1	0	0	0	1
Haemoglobin low	1	0	1	0	2
Hair loss	0	0	1	0	1
Hyperbilirubinemia	0	1	0	0	1
Insomnia	1	0	0	0	1
Lethargic	1	0	0	0	1
Low mood	1	0	0	0	1
Mouth ulcer	1	0	0	0	1
Sores mouth	1	0	0	0	1

*Life-threatening events