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NCT00282308 · ADVERSE EVENTS

Adverse events

A Study to Evaluate the Effects of Rituximab on Immune Responses in Subjects With Active Rheumatoid Arthritis Receiving Background Methotrexate · Source last updated 2017-08-10

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
Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Other-event reporting threshold
5%

Safety population: All patients who received any amount of rituximab or any vaccine.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Rituximab + Methotrexate (Group A) - Treatment Period

Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.

3 / 6851 / 68Not reported / Not reported
Methotrexate (Group B) - Treatment Period

Patients received methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.

2 / 3219 / 32Not reported / Not reported
Group A - Optional Extension Re-treatment Period

Patients who qualified for re-treatment received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/week orally or subcutaneously. Patients received methylprednisolone 100 mg intravenously before each infusion of rituximab.

2 / 527 / 52Not reported / Not reported
Group B - Optional Extension Re-treatment Period

Patients who qualified for re-treatment received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/week orally or subcutaneously. Patients received methylprednisolone 100 mg intravenously before each infusion of rituximab.

2 / 2613 / 26Not reported / Not reported
Group A - Safety Follow-up Period

Patients received no treatment during the Safety Follow-up Period.

3 / 6819 / 68Not reported / Not reported
Group B - Safety Follow-up Period

Patients received no treatment during the Safety Follow-up Period.

1 / 3211 / 32Not reported / Not reported

Group identifiers: EG000: Rituximab + Methotrexate (Group A) - Treatment Period · EG001: Methotrexate (Group B) - Treatment Period · EG002: Group A - Optional Extension Re-treatment Period · EG003: Group B - Optional Extension Re-treatment Period · EG004: Group A - Safety Follow-up Period · EG005: Group B - 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
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      26
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      68
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      32
    term
    Coronary artery disease
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      26
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      68
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      32
    term
    Chest pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      26
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      68
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      32
    term
    Hip fracture
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      26
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      68
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      32
    term
    Rheumatoid arthritis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Reproductive system and breast disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      26
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      68
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      32
    term
    Ovarian cyst
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      26
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      68
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      32
    term
    Amaurosis fugax
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      26
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      68
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      32
    term
    Pyelonephritis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      26
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      68
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      32
    term
    Ovarian cancer
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      26
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      68
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      32
    term
    Thyroid cancer
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      26
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      68
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      32
    term
    Basal cell carcinoma
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      26
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      68
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      32
    term
    Bipolar disorder

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
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      26
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      68
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      32
    term
    Nausea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      26
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      68
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      32
    term
    Diarrhoea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      26
    5. group Id
      EG004
      num Affected
      8
      num At Risk
      68
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      32
    term
    Upper respiratory tract infection
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      26
    5. group Id
      EG004
      num Affected
      7
      num At Risk
      68
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      32
    term
    Sinusitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      26
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      68
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      32
    term
    Influenza
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      26
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      68
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      32
    term
    Rheumatoid arthritis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      26
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      68
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      32
    term
    Arthralgia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      26
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      68
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      32
    term
    Muscle spasms
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      26
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      68
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      32
    term
    Headache
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      26
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      68
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      32
    term
    Insomnia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      26
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      68
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      32
    term
    Throat irritation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      26
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      68
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      32
    term
    Oropharyngeal pain
Complete source fields
description
Safety population: All patients who received any amount of rituximab or any vaccine.
event Groups
  1. description
    Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
    id
    EG000
    other Num Affected
    51
    other Num At Risk
    68
    serious Num Affected
    3
    serious Num At Risk
    68
    title
    Rituximab + Methotrexate (Group A) - Treatment Period
  2. description
    Patients received methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
    id
    EG001
    other Num Affected
    19
    other Num At Risk
    32
    serious Num Affected
    2
    serious Num At Risk
    32
    title
    Methotrexate (Group B) - Treatment Period
  3. description
    Patients who qualified for re-treatment received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/week orally or subcutaneously. Patients received methylprednisolone 100 mg intravenously before each infusion of rituximab.
    id
    EG002
    other Num Affected
    7
    other Num At Risk
    52
    serious Num Affected
    2
    serious Num At Risk
    52
    title
    Group A - Optional Extension Re-treatment Period
  4. description
    Patients who qualified for re-treatment received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/week orally or subcutaneously. Patients received methylprednisolone 100 mg intravenously before each infusion of rituximab.
    id
    EG003
    other Num Affected
    13
    other Num At Risk
    26
    serious Num Affected
    2
    serious Num At Risk
    26
    title
    Group B - Optional Extension Re-treatment Period
  5. description
    Patients received no treatment during the Safety Follow-up Period.
    id
    EG004
    other Num Affected
    19
    other Num At Risk
    68
    serious Num Affected
    3
    serious Num At Risk
    68
    title
    Group A - Safety Follow-up Period
  6. description
    Patients received no treatment during the Safety Follow-up Period.
    id
    EG005
    other Num Affected
    11
    other Num At Risk
    32
    serious Num Affected
    1
    serious Num At Risk
    32
    title
    Group B - Safety Follow-up Period
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      26
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      68
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      32
    term
    Nausea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      26
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      68
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      32
    term
    Diarrhoea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      26
    5. group Id
      EG004
      num Affected
      8
      num At Risk
      68
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      32
    term
    Upper respiratory tract infection
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      26
    5. group Id
      EG004
      num Affected
      7
      num At Risk
      68
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      32
    term
    Sinusitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      26
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      68
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      32
    term
    Influenza
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      26
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      68
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      32
    term
    Rheumatoid arthritis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      26
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      68
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      32
    term
    Arthralgia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      26
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      68
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      32
    term
    Muscle spasms
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      26
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      68
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      32
    term
    Headache
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      26
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      68
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      32
    term
    Insomnia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      26
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      68
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      32
    term
    Throat irritation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      26
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      68
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      32
    term
    Oropharyngeal pain
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      26
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      68
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      32
    term
    Coronary artery disease
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      26
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      68
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      32
    term
    Chest pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      26
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      68
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      32
    term
    Hip fracture
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      26
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      68
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      32
    term
    Rheumatoid arthritis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Reproductive system and breast disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      26
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      68
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      32
    term
    Ovarian cyst
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      26
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      68
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      32
    term
    Amaurosis fugax
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      26
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      68
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      32
    term
    Pyelonephritis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      26
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      68
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      32
    term
    Ovarian cancer
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      26
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      68
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      32
    term
    Thyroid cancer
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      26
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      68
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      32
    term
    Basal cell carcinoma
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      26
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      68
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      32
    term
    Bipolar disorder
time Frame
Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).

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