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NCT02383589 · ADVERSE EVENTS

Adverse events

A Study to Evaluate the Efficacy and Safety of Rituximab Versus Mycophenolate Mofetil (MMF) in Participants With Pemphigus Vulgaris (PV) · Source last updated 2020-11-10

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
Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)
Other-event reporting threshold
5%

The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Rituximab (RTX)

Participants received rituximab by IV infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria had been met. Participants also received MMF matching placebo orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52.

15 / 6742 / 670 / 67
Mycophenolate Mofetil (MMF)

Participants received Mycophenolate Mofetil (MMF) orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52. Participants also received rituximab matching placebo by intravenous (IV) infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria had been met.

10 / 6841 / 681 / 68
RTX Safety Follow-up

Participants, who received RTX in the treatment period, and either withdrew from the treatment period or completed the total 52-week treatment period, entered the SFU period. Participants were observed for 1 year and did not receive any further study treatment.

4 / 662 / 660 / 66
MMF Safety Follow-up

Participants, who received MMF in the treatment period, and either withdrew from the treatment period or completed the total 52-week treatment period, entered the SFU period. Participants were observed for 1 year and did not receive any further study treatment.

1 / 583 / 580 / 58

Group identifiers: EG000: Rituximab (RTX) · EG001: Mycophenolate Mofetil (MMF) · EG002: RTX Safety Follow-up · EG003: MMF Safety Follow-up

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
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      67
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      68
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      66
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      58
      num Events
      0
    term
    MYOCARDIAL INFARCTION
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      67
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      68
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      66
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      58
      num Events
      0
    term
    ABDOMINAL PAIN
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      67
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      68
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      66
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      58
      num Events
      0
    term
    HAEMATEMESIS
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      67
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      68
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      66
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      58
      num Events
      0
    term
    ILEUS
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      67
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      68
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      66
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      58
      num Events
      0
    term
    INCARCERATED UMBILICAL HERNIA
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      67
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      68
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      66
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      58
      num Events
      0
    term
    BURSITIS INFECTIVE
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      67
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      68
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      66
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      58
      num Events
      0
    term
    CELLULITIS
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      67
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      68
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      66
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      58
      num Events
      0
    term
    HERPES ZOSTER
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      67
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      68
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      66
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      58
      num Events
      0
    term
    INFLUENZA
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      67
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      68
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      66
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      58
      num Events
      0
    term
    PNEUMONIA
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      67
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      68
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      66
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      58
      num Events
      0
    term
    PNEUMONIA VIRAL
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      67
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      68
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      66
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      58
      num Events
      0
    term
    PYELONEPHRITIS

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
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      67
      num Events
      14
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      68
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      66
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      58
      num Events
      0
    term
    LYMPHOPENIA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      67
      num Events
      5
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      68
      num Events
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      66
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      58
      num Events
      0
    term
    DIARRHOEA
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      67
      num Events
      4
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      68
      num Events
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      66
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      58
      num Events
      0
    term
    NAUSEA
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      67
      num Events
      5
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      68
      num Events
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      66
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      58
      num Events
      0
    term
    ASTHENIA
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      67
      num Events
      8
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      68
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      66
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      58
      num Events
      0
    term
    FATIGUE
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      67
      num Events
      2
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      68
      num Events
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      66
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      58
      num Events
      0
    term
    OEDEMA PERIPHERAL
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      67
      num Events
      8
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      68
      num Events
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      66
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      58
      num Events
      0
    term
    NASOPHARYNGITIS
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      67
      num Events
      8
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      68
      num Events
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      66
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      58
      num Events
      0
    term
    ORAL CANDIDIASIS
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      67
      num Events
      9
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      68
      num Events
      6
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      66
      num Events
      2
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      58
      num Events
      3
    term
    UPPER RESPIRATORY TRACT INFECTION
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      67
      num Events
      6
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      68
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      66
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      58
      num Events
      0
    term
    URINARY TRACT INFECTION
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      67
      num Events
      19
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      68
      num Events
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      66
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      58
      num Events
      0
    term
    INFUSION RELATED REACTION
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      67
      num Events
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      68
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      66
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      58
      num Events
      0
    term
    HYPOPHOSPHATAEMIA
Complete source fields
description
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes. Only serious adverse events and all infectious adverse events, irrespective of causality, were reported in the SFU period.
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    67
    description
    Participants received rituximab by IV infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria had been met. Participants also received MMF matching placebo orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52.
    id
    EG000
    other Num Affected
    42
    other Num At Risk
    67
    serious Num Affected
    15
    serious Num At Risk
    67
    title
    Rituximab (RTX)
  2. deaths Num Affected
    1
    deaths Num At Risk
    68
    description
    Participants received Mycophenolate Mofetil (MMF) orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52. Participants also received rituximab matching placebo by intravenous (IV) infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria had been met.
    id
    EG001
    other Num Affected
    41
    other Num At Risk
    68
    serious Num Affected
    10
    serious Num At Risk
    68
    title
    Mycophenolate Mofetil (MMF)
  3. deaths Num Affected
    0
    deaths Num At Risk
    66
    description
    Participants, who received RTX in the treatment period, and either withdrew from the treatment period or completed the total 52-week treatment period, entered the SFU period. Participants were observed for 1 year and did not receive any further study treatment.
    id
    EG002
    other Num Affected
    2
    other Num At Risk
    66
    serious Num Affected
    4
    serious Num At Risk
    66
    title
    RTX Safety Follow-up
  4. deaths Num Affected
    0
    deaths Num At Risk
    58
    description
    Participants, who received MMF in the treatment period, and either withdrew from the treatment period or completed the total 52-week treatment period, entered the SFU period. Participants were observed for 1 year and did not receive any further study treatment.
    id
    EG003
    other Num Affected
    3
    other Num At Risk
    58
    serious Num Affected
    1
    serious Num At Risk
    58
    title
    MMF Safety Follow-up
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      67
      num Events
      14
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      68
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      66
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      58
      num Events
      0
    term
    LYMPHOPENIA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      67
      num Events
      5
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      68
      num Events
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      66
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      58
      num Events
      0
    term
    DIARRHOEA
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      67
      num Events
      4
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      68
      num Events
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      66
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      58
      num Events
      0
    term
    NAUSEA
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      67
      num Events
      5
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      68
      num Events
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      66
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      58
      num Events
      0
    term
    ASTHENIA
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      67
      num Events
      8
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      68
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      66
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      58
      num Events
      0
    term
    FATIGUE
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      67
      num Events
      2
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      68
      num Events
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      66
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      58
      num Events
      0
    term
    OEDEMA PERIPHERAL
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      67
      num Events
      8
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      68
      num Events
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      66
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      58
      num Events
      0
    term
    NASOPHARYNGITIS
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      67
      num Events
      8
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      68
      num Events
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      66
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      58
      num Events
      0
    term
    ORAL CANDIDIASIS
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      67
      num Events
      9
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      68
      num Events
      6
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      66
      num Events
      2
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      58
      num Events
      3
    term
    UPPER RESPIRATORY TRACT INFECTION
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      67
      num Events
      6
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      68
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      66
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      58
      num Events
      0
    term
    URINARY TRACT INFECTION
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      67
      num Events
      19
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      68
      num Events
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      66
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      58
      num Events
      0
    term
    INFUSION RELATED REACTION
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      67
      num Events
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      68
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      66
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      58
      num Events
      0
    term
    HYPOPHOSPHATAEMIA
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      67
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      68
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      66
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      58
      num Events
      0
    term
    MYOCARDIAL INFARCTION
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      67
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      68
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      66
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      58
      num Events
      0
    term
    ABDOMINAL PAIN
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      67
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      68
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      66
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      58
      num Events
      0
    term
    HAEMATEMESIS
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      67
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      68
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      66
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      58
      num Events
      0
    term
    ILEUS
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      67
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      68
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      66
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      58
      num Events
      0
    term
    INCARCERATED UMBILICAL HERNIA
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      67
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      68
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      66
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      58
      num Events
      0
    term
    BURSITIS INFECTIVE
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      67
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      68
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      66
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      58
      num Events
      0
    term
    CELLULITIS
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      67
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      68
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      66
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      58
      num Events
      0
    term
    HERPES ZOSTER
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      67
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      68
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      66
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      58
      num Events
      0
    term
    INFLUENZA
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      67
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      68
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      66
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      58
      num Events
      0
    term
    PNEUMONIA
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      67
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      68
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      66
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      58
      num Events
      0
    term
    PNEUMONIA VIRAL
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      67
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      68
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      66
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      58
      num Events
      0
    term
    PYELONEPHRITIS
time Frame
Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019)

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Preserved source evidence · Not medical advice