Study: NCT02414399

Adverse event: Grade 4 or 5 (cardiac disorders)
Serious: yes
Organ System: Cardiac disorders
Notes: Reporting all events that occurred during 6 month follow-up period. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term. Grades assigned using 2014 AIDS Table for Grading the Severity of Pediatric Adverse Events.
Frequency: 1 affected / 702 at risk

Adverse event: Grade 4 or 5 (gastrointestinal disorders)
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Reporting all events that occurred during 6 month follow-up period. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term. Grades assigned using 2014 AIDS Table for Grading the Severity of Pediatric Adverse Events.
Frequency: 2 affected / 702 at risk

Adverse event: Grade 4 or 5 (general disorder)
Serious: yes
Organ System: General disorders
Notes: Reporting all events that occurred during 6 month follow-up period. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term. Grades assigned using 2014 AIDS Table for Grading the Severity of Pediatric Adverse Events.
Frequency: 1 affected / 702 at risk

Adverse event: Grade 4 or 5 (infections)
Serious: yes
Organ System: Infections and infestations
Notes: Reporting all events that occurred during 6 month follow-up period. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term. Grades assigned using 2014 AIDS Table for Grading the Severity of Pediatric Adverse Events.
Frequency: 43 affected / 702 at risk

Adverse event: Grade 4 or 5 (injury or poisoning)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Reporting all events that occurred during 6 month follow-up period. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term. Grades assigned using 2014 AIDS Table for Grading the Severity of Pediatric Adverse Events.
Frequency: 1 affected / 702 at risk

Adverse event: Grade 4 or 5 (renal & urinary disorder)
Serious: yes
Organ System: Renal and urinary disorders
Notes: Reporting all events that occurred during 6 month follow-up period. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term. Grades assigned using 2014 AIDS Table for Grading the Severity of Pediatric Adverse Events.
Frequency: 2 affected / 702 at risk

Adverse event: Grade 4 or 5 (respiratory disorders)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Reporting all events that occurred during 6 month follow-up period. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term. Grades assigned using 2014 AIDS Table for Grading the Severity of Pediatric Adverse Events.
Frequency: 3 affected / 702 at risk

Adverse event: Grade 4 or 5 (blood and lymphatic system disorders)
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Reporting all events that occurred during 6 month follow-up period. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term. Grades assigned using 2014 AIDS Table for Grading the Severity of Pediatric Adverse Events.
Frequency: 13 affected / 702 at risk

Adverse event: Grade 4 or 5 (nervous system disorders)
Serious: yes
Organ System: Nervous system disorders
Notes: Reporting all events that occurred during 6 month follow-up period. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term. Grades assigned using 2014 AIDS Table for Grading the Severity of Pediatric Adverse Events.
Frequency: 1 affected / 702 at risk

Adverse event: Grade 2 (not reported by system)
Serious: no
Organ System: General disorders
Notes: Reporting all events that occurred during 6 month follow-up period. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term. Grades assigned using 2014 AIDS Table for Grading the Severity of Pediatric Adverse Events.
Frequency: 193 affected / 702 at risk

Adverse event: Grade 1 (not reported by system)
Serious: no
Organ System: General disorders
Notes: Reporting all events that occurred during 6 month follow-up period. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term. Grades assigned using 2014 AIDS Table for Grading the Severity of Pediatric Adverse Events.
Frequency: 81 affected / 702 at risk

Adverse event: Grade 4 or 5 (cardiac disorders)
Serious: yes
Organ System: Cardiac disorders
Notes: Reporting all events that occurred during 6 month follow-up period. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term. Grades assigned using 2014 AIDS Table for Grading the Severity of Pediatric Adverse Events.
Frequency: 1 affected / 696 at risk

Adverse event: Grade 4 or 5 congenital disorders
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: Reporting all events that occurred during 6 month follow-up period. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term. Grades assigned using 2014 AIDS Table for Grading the Severity of Pediatric Adverse Events.
Frequency: 1 affected / 696 at risk

Adverse event: Grade 4 or 5 (general disorder)
Serious: yes
Organ System: General disorders
Notes: Reporting all events that occurred during 6 month follow-up period. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term. Grades assigned using 2014 AIDS Table for Grading the Severity of Pediatric Adverse Events.
Frequency: 2 affected / 696 at risk

Adverse event: Grade 4 or 5 (infections)
Serious: yes
Organ System: Infections and infestations
Notes: Reporting all events that occurred during 6 month follow-up period. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term. Grades assigned using 2014 AIDS Table for Grading the Severity of Pediatric Adverse Events.
Frequency: 43 affected / 696 at risk

Adverse event: Grade 4 or 5 (injury or poisoning)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Reporting all events that occurred during 6 month follow-up period. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term. Grades assigned using 2014 AIDS Table for Grading the Severity of Pediatric Adverse Events.
Frequency: 1 affected / 696 at risk

Adverse event: Grade 4 or 5 (renal & urinary disorder)
Serious: yes
Organ System: Renal and urinary disorders
Notes: Reporting all events that occurred during 6 month follow-up period. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term. Grades assigned using 2014 AIDS Table for Grading the Severity of Pediatric Adverse Events.
Frequency: 1 affected / 696 at risk

Adverse event: Grade 4 or 5 (respiratory disorders)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Reporting all events that occurred during 6 month follow-up period. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term. Grades assigned using 2014 AIDS Table for Grading the Severity of Pediatric Adverse Events.
Frequency: 3 affected / 696 at risk

Adverse event: Grade 4 or 5 (blood and lymphatic system disorders)
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Reporting all events that occurred during 6 month follow-up period. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term. Grades assigned using 2014 AIDS Table for Grading the Severity of Pediatric Adverse Events.
Frequency: 16 affected / 696 at risk

Adverse event: Grade 4 or 5 (nervous system disorders)
Serious: yes
Organ System: Nervous system disorders
Notes: Reporting all events that occurred during 6 month follow-up period. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term. Grades assigned using 2014 AIDS Table for Grading the Severity of Pediatric Adverse Events.
Frequency: 5 affected / 696 at risk

Adverse event: Grade 2 (not reported by system)
Serious: no
Organ System: General disorders
Notes: Reporting all events that occurred during 6 month follow-up period. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term. Grades assigned using 2014 AIDS Table for Grading the Severity of Pediatric Adverse Events.
Frequency: 195 affected / 696 at risk

Adverse event: Grade 1 (not reported by system)
Serious: no
Organ System: General disorders
Notes: Reporting all events that occurred during 6 month follow-up period. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term. Grades assigned using 2014 AIDS Table for Grading the Severity of Pediatric Adverse Events.
Frequency: 81 affected / 696 at risk