Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00717366 · ADVERSE EVENTS

Adverse events

Study to Determine Optimum Intravenous Starting Dose of MIRCERA for Treatment of Pediatric Participants With Anemia and Chronic Kidney Disease on Hemodialysis · Source last updated 2017-09-08

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
Baseline up to Week 73
Other-event reporting threshold
5%

Safety population included all participants who received at least one dose of study drug and had a safety follow-up visit.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
MIRCERA Group 1: Intermediate-Conversion-Factor Group

Participants received MIRCERA IV injection at a starting dose based on an intermediate conversion factor from their previous ESA dose (4 \* previous weekly epoetin dose \[IU\]/250 or 4 \* previous weekly darbepoetin alfa dose \[mcg\]/1.1) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had Hb level within ± 1 g/dL of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.

4 / 1611 / 16Not reported / Not reported
MIRCERA Group 2: High-Conversion-Factor Group

Participants received MIRCERA IV injection based on a high conversion factor from their previous ESA dose (4 \* previous weekly epoetin dose \[IU\]/125 or 4 \* previous weekly darbepoetin alfa dose \[mcg\]/0.55) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had Hb level within ± 1 g/dL of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.

17 / 4828 / 48Not reported / Not reported

Group identifiers: EG000: MIRCERA Group 1: Intermediate-Conversion-Factor Group · EG001: MIRCERA Group 2: High-Conversion-Factor Group

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      48
    term
    Device related infection
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      48
    term
    Bronchitis
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      48
    term
    Nasopharyngitis
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      48
    term
    Orchitis
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      48
    term
    Pharyngitis
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      48
    term
    Pneumonia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
    term
    Staphylococcal scalded skin syndrome
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      48
    term
    Arteriovenous fistula thrombosis
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      48
    term
    Procedural haemorrhage
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      48
    term
    Arterial injury
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
    term
    Transplant failure
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      48
    term
    Thrombosis in device

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      48
    term
    Nasopharyngitis
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      48
    term
    Bronchitis
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      48
    term
    Pharyngitis
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      48
    term
    Urinary tract infection
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      48
    term
    Viral infection
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      48
    term
    Catheter site infection
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      48
    term
    Gastroenteritis
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
    term
    H1N1 influenza
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
    term
    Conjunctivitis
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
    term
    Oral herpes
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
    term
    Upper respiratory tract infection
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      48
    term
    Headache
Complete source fields
description
Safety population included all participants who received at least one dose of study drug and had a safety follow-up visit.
event Groups
  1. description
    Participants received MIRCERA IV injection at a starting dose based on an intermediate conversion factor from their previous ESA dose (4 \* previous weekly epoetin dose \[IU\]/250 or 4 \* previous weekly darbepoetin alfa dose \[mcg\]/1.1) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had Hb level within ± 1 g/dL of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.
    id
    EG000
    other Num Affected
    11
    other Num At Risk
    16
    serious Num Affected
    4
    serious Num At Risk
    16
    title
    MIRCERA Group 1: Intermediate-Conversion-Factor Group
  2. description
    Participants received MIRCERA IV injection based on a high conversion factor from their previous ESA dose (4 \* previous weekly epoetin dose \[IU\]/125 or 4 \* previous weekly darbepoetin alfa dose \[mcg\]/0.55) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had Hb level within ± 1 g/dL of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.
    id
    EG001
    other Num Affected
    28
    other Num At Risk
    48
    serious Num Affected
    17
    serious Num At Risk
    48
    title
    MIRCERA Group 2: High-Conversion-Factor Group
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      48
    term
    Nasopharyngitis
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      48
    term
    Bronchitis
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      48
    term
    Pharyngitis
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      48
    term
    Urinary tract infection
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      48
    term
    Viral infection
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      48
    term
    Catheter site infection
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      48
    term
    Gastroenteritis
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
    term
    H1N1 influenza
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
    term
    Conjunctivitis
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
    term
    Oral herpes
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
    term
    Upper respiratory tract infection
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      48
    term
    Headache
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      48
    term
    Device related infection
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      48
    term
    Bronchitis
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      48
    term
    Nasopharyngitis
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      48
    term
    Orchitis
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      48
    term
    Pharyngitis
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      48
    term
    Pneumonia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
    term
    Staphylococcal scalded skin syndrome
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      48
    term
    Arteriovenous fistula thrombosis
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      48
    term
    Procedural haemorrhage
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      48
    term
    Arterial injury
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
    term
    Transplant failure
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      48
    term
    Thrombosis in device
time Frame
Baseline up to Week 73

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice