Study: NCT03302299

Adverse event: Elevated AST or ALT
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: 6 affected / 301 at risk

Adverse event: Accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Injury from accident, resulting in hospitalization
Frequency: 2 affected / 301 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Death - cause unknown
Frequency: 2 affected / 301 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Notes: Septicemia causing hospitalization
Frequency: 1 affected / 301 at risk

Adverse event: Low hemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Low hemoglobin, likely caused by persistent vaginal bleeding. Hospitalization
Frequency: 1 affected / 301 at risk

Adverse event: High blood pressure
Serious: yes
Organ System: Cardiac disorders
Notes: High blood pressure. Hospitalization.
Frequency: 1 affected / 301 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: General disorders
Notes: Hospitalization due to dizziness, loss of appetite, nausea, paresthesia.
Frequency: 1 affected / 301 at risk

Adverse event: Grade 3: AST or ALT elevation
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: 18 affected / 301 at risk

Adverse event: Grade 2: AST or ALT elevation
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: 62 affected / 301 at risk

Adverse event: PPD hypersensitivity
Serious: no
Organ System: Immune system disorders
Notes: Hypersensitivity reaction to the tuberculin purified protein derivative (PPD) test.

The total number at risk includes all people who received the PPD test as part of study screening.
Frequency: 3 affected / 301 at risk

Adverse event: Paresthesias
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 301 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 301 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 301 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 301 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Frequency: 1 affected / 301 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 1 affected / 301 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 301 at risk

Adverse event: Angioedema
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 301 at risk

Adverse event: Allergic conjuctivitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 301 at risk

Adverse event: Shooting pains
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 301 at risk

Adverse event: Visual changes (blurring)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 301 at risk

Adverse event: Hypotension
Serious: no
Organ System: General disorders
Frequency: 1 affected / 301 at risk

Adverse event: Poor appetite
Serious: no
Organ System: General disorders
Frequency: 1 affected / 301 at risk

Adverse event: Physically assaulted
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Physically assaulted by partner (grade 2 injury).
Frequency: 1 affected / 301 at risk

Adverse event: Soft tissue injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Road traffic accident (grade 2 injury)
Frequency: 1 affected / 301 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 301 at risk