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NCT02097745 · ADVERSE EVENTS

Adverse events

A Study of the Efficacy and Safety of Re-treatments With Rituximab in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-tnfa Therapies · Source last updated 2016-11-03

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
Not reported
Other-event reporting threshold
5%

Safety population: All participants who received any part of an infusion of study medication in this study.

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

Data for participants who received placebo in study WA17042 are included in this reporting group for data collected up until they received their first dose of rituximab in this study (study WA17531). Data from these participants collected after the first dose of rituximab are included in the rituximab reporting group.

14 / 140112 / 140Not reported / Not reported
Rituximab

Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.

197 / 335327 / 335Not reported / Not reported

Group identifiers: EG000: Placebo · EG001: Rituximab

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
    Infections and infestations
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      335
    term
    Pneumonia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      335
    term
    Cellulitis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      335
    term
    Gastroenteritis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      335
    term
    Pyelonephritis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      335
    term
    Urinary tract infection
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      335
    term
    Bronchitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      335
    term
    Bronchopneumonia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      335
    term
    Escherichia urinary tract infection
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      335
    term
    Appendicitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      335
    term
    Arthritis infective
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      335
    term
    Clostridium difficile colitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      335
    term
    Pneumonia streptococcal

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
    Infections and infestations
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      132
      num At Risk
      335
    term
    Upper respiratory tract infection
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      101
      num At Risk
      335
    term
    Nasopharyngitis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      86
      num At Risk
      335
    term
    Urinary tract infection
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      81
      num At Risk
      335
    term
    Bronchitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      68
      num At Risk
      335
    term
    Sinusitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      48
      num At Risk
      335
    term
    Gastroenteritis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      45
      num At Risk
      335
    term
    Gastroenteritis viral
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      42
      num At Risk
      335
    term
    Influenza
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      335
    term
    Cellulitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      335
    term
    Rhinitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      335
    term
    Tooth abscess
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      335
    term
    Oral herpes
Complete source fields
description
Safety population: All participants who received any part of an infusion of study medication in this study.
event Groups
  1. description
    Data for participants who received placebo in study WA17042 are included in this reporting group for data collected up until they received their first dose of rituximab in this study (study WA17531). Data from these participants collected after the first dose of rituximab are included in the rituximab reporting group.
    id
    EG000
    other Num Affected
    112
    other Num At Risk
    140
    serious Num Affected
    14
    serious Num At Risk
    140
    title
    Placebo
  2. description
    Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
    id
    EG001
    other Num Affected
    327
    other Num At Risk
    335
    serious Num Affected
    197
    serious Num At Risk
    335
    title
    Rituximab
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      132
      num At Risk
      335
    term
    Upper respiratory tract infection
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      101
      num At Risk
      335
    term
    Nasopharyngitis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      86
      num At Risk
      335
    term
    Urinary tract infection
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      81
      num At Risk
      335
    term
    Bronchitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      68
      num At Risk
      335
    term
    Sinusitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      48
      num At Risk
      335
    term
    Gastroenteritis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      45
      num At Risk
      335
    term
    Gastroenteritis viral
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      42
      num At Risk
      335
    term
    Influenza
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      335
    term
    Cellulitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      335
    term
    Rhinitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      335
    term
    Tooth abscess
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      335
    term
    Oral herpes
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      335
    term
    Pneumonia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      335
    term
    Cellulitis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      335
    term
    Gastroenteritis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      335
    term
    Pyelonephritis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      335
    term
    Urinary tract infection
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      335
    term
    Bronchitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      335
    term
    Bronchopneumonia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      335
    term
    Escherichia urinary tract infection
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      335
    term
    Appendicitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      335
    term
    Arthritis infective
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      335
    term
    Clostridium difficile colitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      335
    term
    Pneumonia streptococcal

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