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NCT02550652 · ADVERSE EVENTS

Adverse events

A Study to Evaluate the Safety and Efficacy of Obinutuzumab Compared With Placebo in Participants With Lupus Nephritis (LN) · Source last updated 2024-08-27

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
From baseline to approximately 7 years and 8 months
Other-event reporting threshold
5%

The safety population was defined as all participants who have received any amount of study medication.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
OBINUTUZUMAB 1000MG + MMF

Participants received obinutuzumab 1000 milligrams (mg) intravenous (IV) infusion on Days 1, 15, 168, and 182 along with MMF/MPA at a starting dose of 1500 mg/day (or equivalent) administered orally in 2 or 3 divided doses. MMF/MPA dose was up titrated to a target dose of 2.0 - 2.5 grams per day (g/day) (or equivalent). Investigators, at their discretion, could use MPA as a substitute for MMF, with a 360 mg dose being equivalent to a 500 mg dose of MMF. During screening or at randomization, if clinically indicated, participants could receive 1000 mg methylprednisolone IV once daily for up to 3 days to treat underlying LN clinical activity. Participants received 0.5 mg/kg oral prednisone, tapering this prednisone dose, per protocol, starting on Day 16 and reducing the prednisone dosage to 7.5 mg/day by Week 12.

17 / 6451 / 641 / 64
PLACEBO + MMF

Participants received placebo matching to obinutuzumab IV infusion on Days 1, 15, 168, and 182 along with MMF/MPA at a starting dose of 1500 mg/day (or equivalent) administered orally in 2 or 3 divided doses. MMF/MPA dose was up titrated to a target dose of 2.0 - 2.5 g/day (or equivalent). Investigators, at their discretion, could use MPA as a substitute for MMF, with a 360 mg dose being equivalent to a 500 mg dose of MMF. During screening or at randomization, if clinically indicated, participants could receive 1000 mg methylprednisolone IV once daily for up to 3 days to treat underlying LN clinical activity. Participants received 0.5 mg/kg oral prednisone, tapering this prednisone dose, per protocol, starting on Day 16 and reducing the prednisone dosage to 7.5 mg/day by Week 12.

18 / 6139 / 614 / 61

Group identifiers: EG000: OBINUTUZUMAB 1000MG + MMF · EG001: PLACEBO + MMF

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
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA, v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      64
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      61
      num Events
      1
    term
    NEUTROPENIA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA, v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      64
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      61
      num Events
      1
    term
    THROMBOCYTOPENIA
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA, v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      64
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      61
      num Events
      1
    term
    CARDIAC FAILURE
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA, v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      64
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      61
      num Events
      1
    term
    INTESTINAL PERFORATION
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA, v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      64
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      61
      num Events
      1
    term
    GENERAL PHYSICAL HEALTH DETERIORATION
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA, v26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      64
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      61
      num Events
      2
    term
    PYREXIA
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA, v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      64
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      61
      num Events
      1
    term
    BRONCHIOLITIS
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA, v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      64
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      61
      num Events
      1
    term
    CYTOMEGALOVIRUS CHORIORETINITIS
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA, v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      64
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      61
      num Events
      1
    term
    CYTOMEGALOVIRUS MYOCARDITIS
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA, v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      64
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      61
      num Events
      1
    term
    DISSEMINATED CYTOMEGALOVIRAL INFECTION
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA, v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      64
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      61
      num Events
      1
    term
    ENDOMETRITIS BACTERIAL
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA, v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      64
      num Events
      1
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      61
      num Events
      3
    term
    HERPES ZOSTER

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, v26.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      64
      num Events
      5
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      61
      num Events
      6
    term
    ANAEMIA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA, v26.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      64
      num Events
      7
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      61
      num Events
      3
    term
    ABDOMINAL PAIN
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA, v26.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      64
      num Events
      3
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      61
      num Events
      5
    term
    DIARRHOEA
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA, v26.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      64
      num Events
      7
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      61
      num Events
      3
    term
    NAUSEA
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA, v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      64
      num Events
      0
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      61
      num Events
      4
    term
    CHEST PAIN
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA, v26.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      64
      num Events
      15
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      61
      num Events
      8
    term
    BRONCHITIS
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA, v26.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      64
      num Events
      6
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      61
      num Events
      2
    term
    CONJUNCTIVITIS
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA, v26.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      64
      num Events
      4
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      61
      num Events
      9
    term
    GASTROENTERITIS
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA, v26.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      64
      num Events
      6
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      61
      num Events
      7
    term
    HERPES ZOSTER
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA, v26.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      64
      num Events
      4
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      61
      num Events
      3
    term
    INFLUENZA
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA, v26.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      64
      num Events
      5
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      61
      num Events
      8
    term
    NASOPHARYNGITIS
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA, v26.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      64
      num Events
      8
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      61
      num Events
      4
    term
    PHARYNGITIS
Complete source fields
description
The safety population was defined as all participants who have received any amount of study medication.
event Groups
  1. deaths Num Affected
    1
    deaths Num At Risk
    64
    description
    Participants received obinutuzumab 1000 milligrams (mg) intravenous (IV) infusion on Days 1, 15, 168, and 182 along with MMF/MPA at a starting dose of 1500 mg/day (or equivalent) administered orally in 2 or 3 divided doses. MMF/MPA dose was up titrated to a target dose of 2.0 - 2.5 grams per day (g/day) (or equivalent). Investigators, at their discretion, could use MPA as a substitute for MMF, with a 360 mg dose being equivalent to a 500 mg dose of MMF. During screening or at randomization, if clinically indicated, participants could receive 1000 mg methylprednisolone IV once daily for up to 3 days to treat underlying LN clinical activity. Participants received 0.5 mg/kg oral prednisone, tapering this prednisone dose, per protocol, starting on Day 16 and reducing the prednisone dosage to 7.5 mg/day by Week 12.
    id
    EG000
    other Num Affected
    51
    other Num At Risk
    64
    serious Num Affected
    17
    serious Num At Risk
    64
    title
    OBINUTUZUMAB 1000MG + MMF
  2. deaths Num Affected
    4
    deaths Num At Risk
    61
    description
    Participants received placebo matching to obinutuzumab IV infusion on Days 1, 15, 168, and 182 along with MMF/MPA at a starting dose of 1500 mg/day (or equivalent) administered orally in 2 or 3 divided doses. MMF/MPA dose was up titrated to a target dose of 2.0 - 2.5 g/day (or equivalent). Investigators, at their discretion, could use MPA as a substitute for MMF, with a 360 mg dose being equivalent to a 500 mg dose of MMF. During screening or at randomization, if clinically indicated, participants could receive 1000 mg methylprednisolone IV once daily for up to 3 days to treat underlying LN clinical activity. Participants received 0.5 mg/kg oral prednisone, tapering this prednisone dose, per protocol, starting on Day 16 and reducing the prednisone dosage to 7.5 mg/day by Week 12.
    id
    EG001
    other Num Affected
    39
    other Num At Risk
    61
    serious Num Affected
    18
    serious Num At Risk
    61
    title
    PLACEBO + MMF
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA, v26.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      64
      num Events
      5
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      61
      num Events
      6
    term
    ANAEMIA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA, v26.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      64
      num Events
      7
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      61
      num Events
      3
    term
    ABDOMINAL PAIN
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA, v26.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      64
      num Events
      3
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      61
      num Events
      5
    term
    DIARRHOEA
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA, v26.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      64
      num Events
      7
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      61
      num Events
      3
    term
    NAUSEA
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA, v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      64
      num Events
      0
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      61
      num Events
      4
    term
    CHEST PAIN
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA, v26.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      64
      num Events
      15
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      61
      num Events
      8
    term
    BRONCHITIS
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA, v26.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      64
      num Events
      6
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      61
      num Events
      2
    term
    CONJUNCTIVITIS
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA, v26.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      64
      num Events
      4
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      61
      num Events
      9
    term
    GASTROENTERITIS
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA, v26.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      64
      num Events
      6
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      61
      num Events
      7
    term
    HERPES ZOSTER
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA, v26.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      64
      num Events
      4
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      61
      num Events
      3
    term
    INFLUENZA
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA, v26.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      64
      num Events
      5
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      61
      num Events
      8
    term
    NASOPHARYNGITIS
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA, v26.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      64
      num Events
      8
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      61
      num Events
      4
    term
    PHARYNGITIS
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA, v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      64
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      61
      num Events
      1
    term
    NEUTROPENIA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA, v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      64
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      61
      num Events
      1
    term
    THROMBOCYTOPENIA
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA, v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      64
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      61
      num Events
      1
    term
    CARDIAC FAILURE
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA, v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      64
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      61
      num Events
      1
    term
    INTESTINAL PERFORATION
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA, v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      64
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      61
      num Events
      1
    term
    GENERAL PHYSICAL HEALTH DETERIORATION
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA, v26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      64
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      61
      num Events
      2
    term
    PYREXIA
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA, v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      64
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      61
      num Events
      1
    term
    BRONCHIOLITIS
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA, v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      64
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      61
      num Events
      1
    term
    CYTOMEGALOVIRUS CHORIORETINITIS
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA, v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      64
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      61
      num Events
      1
    term
    CYTOMEGALOVIRUS MYOCARDITIS
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA, v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      64
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      61
      num Events
      1
    term
    DISSEMINATED CYTOMEGALOVIRAL INFECTION
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA, v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      64
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      61
      num Events
      1
    term
    ENDOMETRITIS BACTERIAL
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA, v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      64
      num Events
      1
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      61
      num Events
      3
    term
    HERPES ZOSTER
time Frame
From baseline to approximately 7 years and 8 months

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Preserved source evidence · Not medical advice