Study: NCT03492216

Adverse event: Elevated ALT or AST
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Grade 4 aspartate transaminase (AST) or alanine transaminase (ALT) elevation defined as AST or ALT \>=10 times the upper limit of normal (ULN).
Frequency: 3 affected / 169 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Hospitalization; surgery for intestinal obstruction
Frequency: 1 affected / 169 at risk

Adverse event: Death
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: esophageal tumor/regurgitation of food
Frequency: 1 affected / 169 at risk

Adverse event: Grade 3: elevated AST or ALT
Serious: no
Organ System: Hepatobiliary disorders
Notes: Grade 3 aspartate transaminase (AST) or alanine transaminase (ALT) elevation defined as AST or ALT \>=5 to \< 10 times the upper limit of normal (ULN).
Frequency: 12 affected / 169 at risk

Adverse event: Grade 2: elevated AST or ALT
Serious: no
Organ System: Hepatobiliary disorders
Notes: Grade 2 aspartate transaminase (AST) or alanine transaminase (ALT) elevation defined as AST or ALT \>2 to \< 5 times the upper limit of normal (ULN).
Frequency: 52 affected / 169 at risk

Adverse event: Myalgia of thighs
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 169 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 169 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 169 at risk

Adverse event: Elevated creatinine
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 169 at risk

Adverse event: Physical assault; hospitalization
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 169 at risk

Adverse event: Elevated ALT or AST
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Grade 4 aspartate transaminase (AST) or alanine transaminase (ALT) elevation defined as AST or ALT \>=10 times the upper limit of normal (ULN).
Frequency: 2 affected / 169 at risk

Adverse event: Alcohol withdrawal
Serious: yes
Organ System: Nervous system disorders
Notes: Alcohol withdrawal delirium and alcohol induced psychosis
Frequency: 1 affected / 169 at risk

Adverse event: Grade 3: elevated AST or ALT
Serious: no
Organ System: Hepatobiliary disorders
Notes: Grade 3 aspartate transaminase (AST) or alanine transaminase (ALT) elevation defined as AST or ALT \>=5 to \< 10 times the upper limit of normal (ULN).
Frequency: 7 affected / 169 at risk

Adverse event: Grade 2: elevated AST or ALT
Serious: no
Organ System: Hepatobiliary disorders
Notes: Grade 2 aspartate transaminase (AST) or alanine transaminase (ALT) elevation defined as AST or ALT \>2 to \< 5 times the upper limit of normal (ULN).
Frequency: 42 affected / 169 at risk

Adverse event: Active TB
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 169 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 169 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 169 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 169 at risk

Adverse event: Elevated ALT or AST
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Grade 4 aspartate transaminase (AST) or alanine transaminase (ALT) elevation defined as AST or ALT \>=10 times the upper limit of normal (ULN).
Frequency: 3 affected / 170 at risk

Adverse event: Road traffic accident; hospitalization
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 170 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Bronchopneumonia resulting in hospitalization
Frequency: 1 affected / 170 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: cause unknown
Frequency: 1 affected / 170 at risk

Adverse event: Death
Serious: yes
Organ System: Infections and infestations
Notes: developed active tuberculosis
Frequency: 1 affected / 170 at risk

Adverse event: Death
Serious: yes
Organ System: Infections and infestations
Notes: sepsis
Frequency: 1 affected / 170 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Per post-mortem report, had bronchopneumonia and haemorrhagic pancreatitis
Frequency: 1 affected / 170 at risk

Adverse event: Grade 3: elevated AST or ALT
Serious: no
Organ System: Hepatobiliary disorders
Notes: Grade 3 aspartate transaminase (AST) or alanine transaminase (ALT) elevation defined as AST or ALT \>=5 to \< 10 times the upper limit of normal (ULN).
Frequency: 14 affected / 170 at risk

Adverse event: Grade 2: elevated AST or ALT
Serious: no
Organ System: Hepatobiliary disorders
Notes: Grade 2 aspartate transaminase (AST) or alanine transaminase (ALT) elevation defined as AST or ALT \>2 to \< 5 times the upper limit of normal (ULN).
Frequency: 40 affected / 170 at risk

Adverse event: Arthralgia of knees
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 170 at risk

Adverse event: Drug-induced lupus
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 170 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 170 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 170 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 170 at risk

Adverse event: Elevated ALT or AST
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Grade 4 aspartate transaminase (AST) or alanine transaminase (ALT) elevation defined as AST or ALT \>=10 times the upper limit of normal (ULN).
Frequency: 3 affected / 172 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Hospitalization secondary to prior spontaneous abortion
Frequency: 1 affected / 172 at risk

Adverse event: Grade 3: elevated AST or ALT
Serious: no
Organ System: Hepatobiliary disorders
Notes: Grade 3 aspartate transaminase (AST) or alanine transaminase (ALT) elevation defined as AST or ALT \>=5 to \< 10 times the upper limit of normal (ULN).
Frequency: 9 affected / 172 at risk

Adverse event: Grade 2: elevated AST or ALT
Serious: no
Organ System: Hepatobiliary disorders
Notes: Grade 2 aspartate transaminase (AST) or alanine transaminase (ALT) elevation defined as AST or ALT \>2 to \< 5 times the upper limit of normal (ULN).
Frequency: 31 affected / 172 at risk