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NCT00299130 · ADVERSE EVENTS

Adverse events

A Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate Compared to Methotrexate Alone in Patients With Active Rheumatoid Arthritis · Source last updated 2017-04-17

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 5.1 years after last dose in treatment period (treatment period = up to 5 years)
Other-event reporting threshold
5%

During the 5-year treatment period, all adverse events (AEs) regardless of seriousness were reported. During the standard 48-week safety follow-up (SFU) and extended safety follow-up (ESFU), all serious adverse events (SAEs) and all non-serious infections were reported.

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

Includes all data for participants who remained on placebo, and data up to the point of switch if the participant switched to treatment with rituximab. Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period.

16 / 172112 / 172Not reported / Not reported
Rituximab 2 x 0.5 g + MTX

Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period.

52 / 167149 / 167Not reported / Not reported
Rituximab 1.0 g + MTX

Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period.

46 / 170151 / 170Not reported / Not reported
Switch Population: Placebo + MTX

Includes all data up to the point of switch for participants in the Placebo + Methotrexate treatment group who switched to treatment with rituximab after Week 24.

12 / 15599 / 155Not reported / Not reported
Switch Population: Rituximab

Includes all data from the point of switch for participants who switched from Placebo + Methotrexate to treatment with rituximab.

45 / 155131 / 155Not reported / Not reported
Rituximab 2 x 0.5 g + MTX - Extended Safety Follow-up Period

Participants received no treatment during the extended safety follow-up period.

8 / 825 / 82Not reported / Not reported
Rituximab 2 x 1.0 g + MTX - Extended Safety Follow-up Period

Participants received no treatment during the extended safety follow-up period.

2 / 442 / 44Not reported / Not reported

Group identifiers: EG000: Placebo + MTX · EG001: Rituximab 2 x 0.5 g + MTX · EG002: Rituximab 1.0 g + MTX · EG003: Switch Population: Placebo + MTX · EG004: Switch Population: Rituximab · EG005: Rituximab 2 x 0.5 g + MTX - Extended Safety Follow-up Period · EG006: Rituximab 2 x 1.0 g + MTX - Extended Safety Follow-up Period

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      172
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      167
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      170
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      155
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      155
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      82
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      44
    term
    Pneumonia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      172
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      167
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      170
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      155
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      155
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      82
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      44
    term
    Gastroenteritis
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      172
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      167
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      170
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      155
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      155
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      82
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      44
    term
    Urinary tract infection
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      172
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      167
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      170
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      155
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      155
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      82
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      44
    term
    Cellulitis
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      172
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      167
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      170
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      155
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      155
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      82
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      44
    term
    Appendicitis
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      172
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      167
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      170
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      155
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      155
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      82
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      44
    term
    Bronchitis
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      172
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      167
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      170
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      155
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      155
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      82
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      44
    term
    Diverticulitis
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      172
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      167
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      170
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      155
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      155
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      82
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      44
    term
    Bronchopneumonia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      172
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      167
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      170
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      155
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      155
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      82
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      44
    term
    Lower respiratory tract infection
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      172
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      167
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      170
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      155
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      155
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      82
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      44
    term
    Postoperative wound infection
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      172
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      167
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      170
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      155
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      155
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      82
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      44
    term
    Abdominal abscess
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      172
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      167
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      170
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      155
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      155
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      82
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      44
    term
    Abdominal sepsis

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      172
    2. group Id
      EG001
      num Affected
      59
      num At Risk
      167
    3. group Id
      EG002
      num Affected
      50
      num At Risk
      170
    4. group Id
      EG003
      num Affected
      13
      num At Risk
      155
    5. group Id
      EG004
      num Affected
      39
      num At Risk
      155
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      82
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      44
    term
    Upper respiratory tract infection
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      172
    2. group Id
      EG001
      num Affected
      43
      num At Risk
      167
    3. group Id
      EG002
      num Affected
      42
      num At Risk
      170
    4. group Id
      EG003
      num Affected
      16
      num At Risk
      155
    5. group Id
      EG004
      num Affected
      34
      num At Risk
      155
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      82
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      44
    term
    Nasopharyngitis
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      172
    2. group Id
      EG001
      num Affected
      41
      num At Risk
      167
    3. group Id
      EG002
      num Affected
      25
      num At Risk
      170
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      155
    5. group Id
      EG004
      num Affected
      34
      num At Risk
      155
    6. group Id
      EG005
      num Affected
      5
      num At Risk
      82
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      44
    term
    Urinary tract infection
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      172
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      167
    3. group Id
      EG002
      num Affected
      25
      num At Risk
      170
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      155
    5. group Id
      EG004
      num Affected
      24
      num At Risk
      155
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      82
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      44
    term
    Bronchitis
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      172
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      167
    3. group Id
      EG002
      num Affected
      21
      num At Risk
      170
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      155
    5. group Id
      EG004
      num Affected
      29
      num At Risk
      155
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      82
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      44
    term
    Sinusitis
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      172
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      167
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      170
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      155
    5. group Id
      EG004
      num Affected
      17
      num At Risk
      155
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      82
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      44
    term
    Gastroenteritis
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      172
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      167
    3. group Id
      EG002
      num Affected
      20
      num At Risk
      170
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      155
    5. group Id
      EG004
      num Affected
      13
      num At Risk
      155
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      82
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      44
    term
    Influenza
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      172
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      167
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      170
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      155
    5. group Id
      EG004
      num Affected
      9
      num At Risk
      155
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      82
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      44
    term
    Pharyngitis
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      172
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      167
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      170
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      155
    5. group Id
      EG004
      num Affected
      7
      num At Risk
      155
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      82
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      44
    term
    Tooth abscess
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      172
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      167
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      170
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      155
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      155
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      82
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      44
    term
    Herpes zoster
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      172
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      167
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      170
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      155
    5. group Id
      EG004
      num Affected
      9
      num At Risk
      155
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      82
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      44
    term
    Lower respiratory tract infection
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      172
    2. group Id
      EG001
      num Affected
      49
      num At Risk
      167
    3. group Id
      EG002
      num Affected
      36
      num At Risk
      170
    4. group Id
      EG003
      num Affected
      26
      num At Risk
      155
    5. group Id
      EG004
      num Affected
      31
      num At Risk
      155
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    term
    Rheumatoid arthritis
Complete source fields
description
During the 5-year treatment period, all adverse events (AEs) regardless of seriousness were reported. During the standard 48-week safety follow-up (SFU) and extended safety follow-up (ESFU), all serious adverse events (SAEs) and all non-serious infections were reported.
event Groups
  1. description
    Includes all data for participants who remained on placebo, and data up to the point of switch if the participant switched to treatment with rituximab. Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period.
    id
    EG000
    other Num Affected
    112
    other Num At Risk
    172
    serious Num Affected
    16
    serious Num At Risk
    172
    title
    Placebo + MTX
  2. description
    Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period.
    id
    EG001
    other Num Affected
    149
    other Num At Risk
    167
    serious Num Affected
    52
    serious Num At Risk
    167
    title
    Rituximab 2 x 0.5 g + MTX
  3. description
    Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period.
    id
    EG002
    other Num Affected
    151
    other Num At Risk
    170
    serious Num Affected
    46
    serious Num At Risk
    170
    title
    Rituximab 1.0 g + MTX
  4. description
    Includes all data up to the point of switch for participants in the Placebo + Methotrexate treatment group who switched to treatment with rituximab after Week 24.
    id
    EG003
    other Num Affected
    99
    other Num At Risk
    155
    serious Num Affected
    12
    serious Num At Risk
    155
    title
    Switch Population: Placebo + MTX
  5. description
    Includes all data from the point of switch for participants who switched from Placebo + Methotrexate to treatment with rituximab.
    id
    EG004
    other Num Affected
    131
    other Num At Risk
    155
    serious Num Affected
    45
    serious Num At Risk
    155
    title
    Switch Population: Rituximab
  6. description
    Participants received no treatment during the extended safety follow-up period.
    id
    EG005
    other Num Affected
    5
    other Num At Risk
    82
    serious Num Affected
    8
    serious Num At Risk
    82
    title
    Rituximab 2 x 0.5 g + MTX - Extended Safety Follow-up Period
  7. description
    Participants received no treatment during the extended safety follow-up period.
    id
    EG006
    other Num Affected
    2
    other Num At Risk
    44
    serious Num Affected
    2
    serious Num At Risk
    44
    title
    Rituximab 2 x 1.0 g + MTX - Extended Safety Follow-up Period
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      172
    2. group Id
      EG001
      num Affected
      59
      num At Risk
      167
    3. group Id
      EG002
      num Affected
      50
      num At Risk
      170
    4. group Id
      EG003
      num Affected
      13
      num At Risk
      155
    5. group Id
      EG004
      num Affected
      39
      num At Risk
      155
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      82
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      44
    term
    Upper respiratory tract infection
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      172
    2. group Id
      EG001
      num Affected
      43
      num At Risk
      167
    3. group Id
      EG002
      num Affected
      42
      num At Risk
      170
    4. group Id
      EG003
      num Affected
      16
      num At Risk
      155
    5. group Id
      EG004
      num Affected
      34
      num At Risk
      155
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      82
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      44
    term
    Nasopharyngitis
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      172
    2. group Id
      EG001
      num Affected
      41
      num At Risk
      167
    3. group Id
      EG002
      num Affected
      25
      num At Risk
      170
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      155
    5. group Id
      EG004
      num Affected
      34
      num At Risk
      155
    6. group Id
      EG005
      num Affected
      5
      num At Risk
      82
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      44
    term
    Urinary tract infection
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      172
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      167
    3. group Id
      EG002
      num Affected
      25
      num At Risk
      170
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      155
    5. group Id
      EG004
      num Affected
      24
      num At Risk
      155
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      82
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      44
    term
    Bronchitis
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      172
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      167
    3. group Id
      EG002
      num Affected
      21
      num At Risk
      170
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      155
    5. group Id
      EG004
      num Affected
      29
      num At Risk
      155
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      82
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      44
    term
    Sinusitis
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      172
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      167
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      170
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      155
    5. group Id
      EG004
      num Affected
      17
      num At Risk
      155
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      82
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      44
    term
    Gastroenteritis
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      172
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      167
    3. group Id
      EG002
      num Affected
      20
      num At Risk
      170
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      155
    5. group Id
      EG004
      num Affected
      13
      num At Risk
      155
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      82
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      44
    term
    Influenza
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      172
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      167
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      170
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      155
    5. group Id
      EG004
      num Affected
      9
      num At Risk
      155
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      82
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      44
    term
    Pharyngitis
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      172
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      167
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      170
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      155
    5. group Id
      EG004
      num Affected
      7
      num At Risk
      155
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      82
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      44
    term
    Tooth abscess
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      172
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      167
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      170
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      155
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      155
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      82
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      44
    term
    Herpes zoster
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      172
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      167
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      170
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      155
    5. group Id
      EG004
      num Affected
      9
      num At Risk
      155
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      82
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      44
    term
    Lower respiratory tract infection
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      172
    2. group Id
      EG001
      num Affected
      49
      num At Risk
      167
    3. group Id
      EG002
      num Affected
      36
      num At Risk
      170
    4. group Id
      EG003
      num Affected
      26
      num At Risk
      155
    5. group Id
      EG004
      num Affected
      31
      num At Risk
      155
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    term
    Rheumatoid arthritis
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      172
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      167
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      170
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      155
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      155
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      82
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      44
    term
    Pneumonia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      172
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      167
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      170
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      155
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      155
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      82
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      44
    term
    Gastroenteritis
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      172
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      167
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      170
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      155
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      155
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      82
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      44
    term
    Urinary tract infection
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      172
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      167
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      170
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      155
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      155
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      82
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      44
    term
    Cellulitis
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      172
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      167
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      170
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      155
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      155
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      82
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      44
    term
    Appendicitis
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      172
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      167
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      170
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      155
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      155
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      82
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      44
    term
    Bronchitis
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      172
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      167
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      170
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      155
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      155
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      82
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      44
    term
    Diverticulitis
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      172
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      167
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      170
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      155
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      155
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      82
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      44
    term
    Bronchopneumonia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      172
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      167
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      170
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      155
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      155
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      82
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      44
    term
    Lower respiratory tract infection
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      172
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      167
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      170
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      155
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      155
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      82
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      44
    term
    Postoperative wound infection
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      172
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      167
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      170
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      155
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      155
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      82
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      44
    term
    Abdominal abscess
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      172
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      167
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      170
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      155
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      155
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      82
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      44
    term
    Abdominal sepsis
time Frame
Up to 5.1 years after last dose in treatment period (treatment period = up to 5 years)

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Preserved source evidence · Not medical advice