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NCT04221477 · ADVERSE EVENTS

Adverse events

A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With ISN/RPS 2003 Class III or IV Lupus Nephritis · Source last updated 2026-07-21

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
Up to Week 76 Data collected up to the primary completion date (Up to Week 76) is reported. Data collection post Week 76 is still ongoing. Final data will be reported 1 year after the study completion date. As pre-specified in the SAP, safety data were to be provided for obinutuzumab (combined treatment groups) and placebo groups. AE data were collected for all Obinutuzumab participants together, without regard to or information of the specific Obinutuzumab group participants they were part of.
Other-event reporting threshold
5%

Safety evaluable population=all participants who received any part of blinded infusion of Obinutuzumab/placebo \& are grouped according to treatment they received. 3 participants from placebo arm did not receive treatment \& were excluded from the safety analysis. 1 participant randomized to placebo arm received obinutuzumab \& was included in obinutuzumab arm for safety analysis. Includes AEs until point of rescue for participants who received rescue therapy (except corticosteroid-only rescue).

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Obinutuzumab

Participants received obinutuzumab, 1000 mg as an IV infusion on Day 1 and Weeks 2, 24, 26, and either Weeks 50 and 52 or Week 52 only, along with MMF and SOC therapy. Placebo was administered at Week 50 for participants not treated with obinutuzumab. Participants with adequate response at Week 76 continued to receive obinutuzumab at Week 80 and Q6M thereafter. The dose of MMF can be adjusted at the investigator's discretion beginning at Week 80.

44 / 136107 / 1365 / 136
Placebo

Participants received Obinutuzumab matching placebo as an IV infusion on Day 1 and Weeks 2, 24, 26, 50, and 52. Participants also received SOC therapy and MMF. Participants with adequate response at Week 76 continued to receive placebo at Week 80 and Q6M thereafter.

24 / 13294 / 1324 / 132

Group identifiers: EG000: Obinutuzumab · EG001: Placebo

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 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      136
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      132
      num Events
      0
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      136
      num Events
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      132
      num Events
      0
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      136
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      132
      num Events
      0
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      136
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      132
      num Events
      0
    term
    Acute coronary syndrome
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      136
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      132
      num Events
      1
    term
    Pericardial effusion
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      136
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      132
      num Events
      0
    term
    Scintillating scotoma
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      136
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      132
      num Events
      1
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      136
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      132
      num Events
      1
    term
    Anal inflammation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      136
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      132
      num Events
      1
    term
    Gastric ulcer haemorrhage
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      136
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      132
      num Events
      1
    term
    Gastritis erosive
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      136
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      132
      num Events
      0
    term
    Large intestinal stenosis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      136
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      132
      num Events
      0
    term
    Small intestinal obstruction

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 27.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      136
      num Events
      7
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      132
      num Events
      10
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      136
      num Events
      10
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      132
      num Events
      8
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      136
      num Events
      14
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      132
      num Events
      5
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      136
      num Events
      6
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      132
      num Events
      16
    term
    Abdominal pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      136
      num Events
      33
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      132
      num Events
      35
    term
    Diarrhoea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      136
      num Events
      9
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      132
      num Events
      15
    term
    Nausea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      136
      num Events
      14
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      132
      num Events
      12
    term
    Vomiting
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      136
      num Events
      5
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      132
      num Events
      8
    term
    Pyrexia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      136
      num Events
      13
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      132
      num Events
      12
    term
    Bronchitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      136
      num Events
      40
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      132
      num Events
      32
    term
    COVID-19
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      136
      num Events
      7
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      132
      num Events
      14
    term
    Gastroenteritis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      136
      num Events
      11
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      132
      num Events
      7
    term
    Herpes zoster
Complete source fields
description
Safety evaluable population=all participants who received any part of blinded infusion of Obinutuzumab/placebo \& are grouped according to treatment they received. 3 participants from placebo arm did not receive treatment \& were excluded from the safety analysis. 1 participant randomized to placebo arm received obinutuzumab \& was included in obinutuzumab arm for safety analysis. Includes AEs until point of rescue for participants who received rescue therapy (except corticosteroid-only rescue).
event Groups
  1. deaths Num Affected
    5
    deaths Num At Risk
    136
    description
    Participants received obinutuzumab, 1000 mg as an IV infusion on Day 1 and Weeks 2, 24, 26, and either Weeks 50 and 52 or Week 52 only, along with MMF and SOC therapy. Placebo was administered at Week 50 for participants not treated with obinutuzumab. Participants with adequate response at Week 76 continued to receive obinutuzumab at Week 80 and Q6M thereafter. The dose of MMF can be adjusted at the investigator's discretion beginning at Week 80.
    id
    EG000
    other Num Affected
    107
    other Num At Risk
    136
    serious Num Affected
    44
    serious Num At Risk
    136
    title
    Obinutuzumab
  2. deaths Num Affected
    4
    deaths Num At Risk
    132
    description
    Participants received Obinutuzumab matching placebo as an IV infusion on Day 1 and Weeks 2, 24, 26, 50, and 52. Participants also received SOC therapy and MMF. Participants with adequate response at Week 76 continued to receive placebo at Week 80 and Q6M thereafter.
    id
    EG001
    other Num Affected
    94
    other Num At Risk
    132
    serious Num Affected
    24
    serious Num At Risk
    132
    title
    Placebo
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      136
      num Events
      7
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      132
      num Events
      10
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      136
      num Events
      10
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      132
      num Events
      8
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      136
      num Events
      14
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      132
      num Events
      5
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      136
      num Events
      6
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      132
      num Events
      16
    term
    Abdominal pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      136
      num Events
      33
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      132
      num Events
      35
    term
    Diarrhoea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      136
      num Events
      9
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      132
      num Events
      15
    term
    Nausea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      136
      num Events
      14
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      132
      num Events
      12
    term
    Vomiting
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      136
      num Events
      5
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      132
      num Events
      8
    term
    Pyrexia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      136
      num Events
      13
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      132
      num Events
      12
    term
    Bronchitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      136
      num Events
      40
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      132
      num Events
      32
    term
    COVID-19
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      136
      num Events
      7
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      132
      num Events
      14
    term
    Gastroenteritis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      136
      num Events
      11
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      132
      num Events
      7
    term
    Herpes zoster
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      136
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      132
      num Events
      0
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      136
      num Events
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      132
      num Events
      0
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      136
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      132
      num Events
      0
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      136
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      132
      num Events
      0
    term
    Acute coronary syndrome
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      136
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      132
      num Events
      1
    term
    Pericardial effusion
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      136
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      132
      num Events
      0
    term
    Scintillating scotoma
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      136
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      132
      num Events
      1
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      136
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      132
      num Events
      1
    term
    Anal inflammation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      136
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      132
      num Events
      1
    term
    Gastric ulcer haemorrhage
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      136
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      132
      num Events
      1
    term
    Gastritis erosive
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      136
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      132
      num Events
      0
    term
    Large intestinal stenosis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      136
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      132
      num Events
      0
    term
    Small intestinal obstruction
time Frame
Up to Week 76 Data collected up to the primary completion date (Up to Week 76) is reported. Data collection post Week 76 is still ongoing. Final data will be reported 1 year after the study completion date. As pre-specified in the SAP, safety data were to be provided for obinutuzumab (combined treatment groups) and placebo groups. AE data were collected for all Obinutuzumab participants together, without regard to or information of the specific Obinutuzumab group participants they were part of.

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