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NCT00266227 · ADVERSE EVENTS

Adverse events

A Study of Retreatment With Rituximab in Patients With Rheumatoid Arthritis Receiving Background Methotrexate · Source last updated 2013-10-25

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%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm A: Rituximab Retreatment

1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.

42 / 320291 / 320Not reported / Not reported
Arm B: Placebo Retreatment

1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by retreatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/week methotrexate.

19 / 155148 / 155Not reported / Not reported
Rituximab-Not Randomized to Retreatment

1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate. Participants were not randomized to Retreatment.

9 / 8471 / 84Not reported / Not reported

Group identifiers: EG000: Arm A: Rituximab Retreatment · EG001: Arm B: Placebo Retreatment · EG002: Rituximab-Not Randomized to Retreatment

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
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      155
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      84
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      155
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      84
    term
    Myocardial infarction
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      155
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      84
    term
    Acute coronary syndrome
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      155
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      84
    term
    Acute myocardial infarction
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      155
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      84
    term
    Coronary artery disease
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      155
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      84
    term
    Coronary artery occlusion
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      155
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      84
    term
    Atrial fibrillation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      155
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      84
    term
    Supraventricular tachycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      155
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      84
    term
    Cardiac failure congestive
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      155
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      84
    term
    Pericarditis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      155
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      84
    term
    Cardio-respiratory arrest
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      155
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      84
    term
    Colitis

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
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      155
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      84
    term
    Nausea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      155
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      84
    term
    Diarrhoea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      155
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      84
    term
    Fatigue
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      155
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      84
    term
    Pyrexia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      71
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      155
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      84
    term
    Upper respiratory tract infection
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      45
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      155
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      84
    term
    Sinusitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      155
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      84
    term
    Nasopharyngitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      44
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      155
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      84
    term
    Urinary tract infection
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      155
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      84
    term
    Bronchitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      74
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      59
      num At Risk
      155
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      84
    term
    Rheumatoid arthritis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      155
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      84
    term
    Back pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      155
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      84
    term
    Arthralgia
Complete source fields
event Groups
  1. description
    1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
    id
    EG000
    other Num Affected
    291
    other Num At Risk
    320
    serious Num Affected
    42
    serious Num At Risk
    320
    title
    Arm A: Rituximab Retreatment
  2. description
    1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by retreatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/week methotrexate.
    id
    EG001
    other Num Affected
    148
    other Num At Risk
    155
    serious Num Affected
    19
    serious Num At Risk
    155
    title
    Arm B: Placebo Retreatment
  3. description
    1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate. Participants were not randomized to Retreatment.
    id
    EG002
    other Num Affected
    71
    other Num At Risk
    84
    serious Num Affected
    9
    serious Num At Risk
    84
    title
    Rituximab-Not Randomized to Retreatment
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      155
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      84
    term
    Nausea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      155
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      84
    term
    Diarrhoea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      155
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      84
    term
    Fatigue
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      155
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      84
    term
    Pyrexia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      71
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      155
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      84
    term
    Upper respiratory tract infection
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      45
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      155
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      84
    term
    Sinusitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      155
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      84
    term
    Nasopharyngitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      44
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      155
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      84
    term
    Urinary tract infection
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      155
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      84
    term
    Bronchitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      74
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      59
      num At Risk
      155
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      84
    term
    Rheumatoid arthritis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      155
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      84
    term
    Back pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      155
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      84
    term
    Arthralgia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      155
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      84
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      155
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      84
    term
    Myocardial infarction
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      155
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      84
    term
    Acute coronary syndrome
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      155
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      84
    term
    Acute myocardial infarction
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      155
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      84
    term
    Coronary artery disease
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      155
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      84
    term
    Coronary artery occlusion
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      155
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      84
    term
    Atrial fibrillation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      155
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      84
    term
    Supraventricular tachycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      155
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      84
    term
    Cardiac failure congestive
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      155
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      84
    term
    Pericarditis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      155
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      84
    term
    Cardio-respiratory arrest
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      155
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      84
    term
    Colitis

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

Preserved source evidence · Not medical advice