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NCT01469013 · ADVERSE EVENTS

Adverse events

Oral Baricitinib (LY3009104)Treatment in Japanese Participants With Active Rheumatoid Arthritis on Background Methotrexate Therapy · Source last updated 2019-09-20

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
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Placebo

Participants on background methotrexate therapy administered 2 placebo capsules, orally once daily for 12 weeks.

1 / 4926 / 49Not reported / Not reported
1 mg Baricitinib (LY3009104)

Participants on background methotrexate therapy administered 1 x 1-mg baricitinib (LY3009104) capsule + 1 identical placebo capsule, orally once daily for 12 weeks.

0 / 2411 / 24Not reported / Not reported
2 mg Baricitinib (LY3009104)

Participants on background methotrexate therapy administered 2 x 1-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks.

1 / 2412 / 24Not reported / Not reported
4 mg Baricitinib (LY3009104)

Participants on background methotrexate therapy administered 1 x 4-mg baricitinib (LY3009104) capsule +1 identical placebo capsule, orally once daily for 12 weeks.

0 / 2413 / 24Not reported / Not reported
8 mg Baricitinib (LY3009104)

Participants on background methotrexate therapy administered 2 x 4-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks.

1 / 2417 / 24Not reported / Not reported
Placebo / 4 mg Baricitinib (LY3009104)

Participants on background methotrexate therapy who were administered placebo capsule, orally once daily for 12 weeks in Part A received 4 mg baricitinib (LY3009104) and 1 placebo tablet orally once daily for 52 weeks in Part B.

1 / 2421 / 24Not reported / Not reported
1 mg Baricitinib (LY3009104) / 4mg Baricitinib (LY3009104)

Participants on background methotrexate therapy who were administered 1 mg baricitinib (LY3009104) capsule, orally once daily for 12 weeks in Part A received 4 mg baricitinib (LY3009104) and 1 placebo tablet orally once daily for 52 weeks in Part B.

1 / 1211 / 12Not reported / Not reported
2 mg Baricitinib (LY3009104) / 4 mg Baricitinib (LY3009104)

Participants on background methotrexate therapy who were administered 2 mg baricitinib (LY3009104) capsule, orally once daily for 12 weeks in Part A received 4 mg baricitinib (LY3009104) and 1 placebo tablet orally once daily for 52 weeks in Part B.

3 / 1211 / 12Not reported / Not reported
4 mg Baricitinib (LY3009104) / 4 mg Baricitinib (LY3009104)

Participants on background methotrexate therapy who were administered 4 mg baricitinib (LY3009104) capsule, orally once daily for 12 weeks in Part A received 4 mg baricitinib (LY3009104) and 1 placebo tablet orally once daily for 52 weeks in Part B.

3 / 2322 / 23Not reported / Not reported
Placebo /8 mg Baricitinib (LY3009104)

Participants on background methotrexate therapy who were administered placebo capsule, orally once daily for 12 weeks in Part A received 2 x 4 mg baricitinib (LY3009104) tablets orally once daily for 52 weeks in Part B.

2 / 2323 / 23Not reported / Not reported
1 mg Baricitinib (LY3009104) / 8 mg Baricitinib (LY3009104)

Participants on background methotrexate therapy who were administered 1 mg baricitinib (LY3009104) capsule, orally once daily for 12 weeks in Part A received 2 x 4 mg baricitinib (LY3009104) tablets orally once daily for 52 weeks in Part B.

2 / 1111 / 11Not reported / Not reported
2 mg Baricitinib (LY3009104) / 8 mg Baricitinib (LY3009104)

Participants on background methotrexate therapy who were administered 2 mg baricitinib (LY3009104) capsule, orally once daily for 12 weeks in Part A received 2 x 4 mg baricitinib (LY3009104) tablets orally once daily for 52 weeks in Part B.

2 / 1212 / 12Not reported / Not reported
8 mg Baricitinib (LY3009104) / 8 mg Baricitinib (LY3009104)

Participants on background methotrexate therapy who were administered 8 mg baricitinib (LY3009104) capsule, orally once daily for 12 weeks in Part A received 2 x 4 mg baricitinib (LY3009104) tablets orally once daily for 52 weeks in Part B.

6 / 2423 / 24Not reported / Not reported

Group identifiers: EG000: Placebo · EG001: 1 mg Baricitinib (LY3009104) · EG002: 2 mg Baricitinib (LY3009104) · EG003: 4 mg Baricitinib (LY3009104) · EG004: 8 mg Baricitinib (LY3009104) · EG005: Placebo / 4 mg Baricitinib (LY3009104) · EG006: 1 mg Baricitinib (LY3009104) / 4mg Baricitinib (LY3009104) · EG007: 2 mg Baricitinib (LY3009104) / 4 mg Baricitinib (LY3009104) · EG008: 4 mg Baricitinib (LY3009104) / 4 mg Baricitinib (LY3009104) · EG009: Placebo /8 mg Baricitinib (LY3009104) · EG010: 1 mg Baricitinib (LY3009104) / 8 mg Baricitinib (LY3009104) · EG011: 2 mg Baricitinib (LY3009104) / 8 mg Baricitinib (LY3009104) · EG012: 8 mg Baricitinib (LY3009104) / 8 mg Baricitinib (LY3009104)

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
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      49
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      24
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      23
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      23
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      11
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Angina pectoris
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      49
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      24
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      23
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      23
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      11
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Myocardial infarction
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      49
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      24
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      23
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      23
      num Events
      1
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      11
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Meniere's disease
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      49
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      24
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      24
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      23
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      23
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      11
      num Events
      0
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Cataract
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      49
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      24
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      12
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      23
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      23
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      11
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Large intestine polyp
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      49
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      24
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      24
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      12
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      23
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      23
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      11
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Pancreatitis acute
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      24
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      23
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      23
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      11
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Cholecystitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      49
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      24
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      23
      num Events
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      23
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      11
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Gastroenteritis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      49
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      24
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      12
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      23
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      23
      num Events
      0
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      11
      num Events
      1
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Herpes zoster
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      49
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      24
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      24
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      23
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      23
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      11
      num Events
      0
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Pneumocystis jirovecii pneumonia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      49
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      24
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      12
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      23
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      23
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      11
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Pneumonia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      49
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      24
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      12
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      23
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      23
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      11
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Clavicle fracture

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      49
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      24
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      24
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      24
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      12
      num Events
      1
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      23
      num Events
      2
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      23
      num Events
      1
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      11
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      49
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      24
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      23
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      23
      num Events
      2
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      11
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Haemorrhagic anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      49
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      24
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      23
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      23
      num Events
      0
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      11
      num Events
      1
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Iron deficiency anaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      49
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      24
      num Events
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      24
      num Events
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      23
      num Events
      0
    10. group Id
      EG009
      num Affected
      3
      num At Risk
      23
      num Events
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      11
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      24
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      24
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      24
      num Events
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      24
      num Events
      1
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      12
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    9. group Id
      EG008
      num Affected
      3
      num At Risk
      23
      num Events
      4
    10. group Id
      EG009
      num Affected
      3
      num At Risk
      23
      num Events
      4
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      11
      num Events
      1
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Lymphopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      49
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      24
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      12
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      23
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      23
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      11
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Pancytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      49
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      24
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      23
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      23
      num Events
      1
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      11
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Arrhythmia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      49
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      24
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      23
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      23
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      11
      num Events
      0
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Bradycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      49
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      24
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      23
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      23
      num Events
      1
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      11
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Sinus tachycardia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      49
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      24
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      23
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      23
      num Events
      1
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      11
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Ventricular extrasystoles
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Congenital, familial and genetic disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      49
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      24
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      23
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      23
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      11
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Birth mark
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      49
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      24
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      23
      num Events
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      23
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      11
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Deafness neurosensory
Complete source fields
event Groups
  1. description
    Participants on background methotrexate therapy administered 2 placebo capsules, orally once daily for 12 weeks.
    id
    EG000
    other Num Affected
    26
    other Num At Risk
    49
    serious Num Affected
    1
    serious Num At Risk
    49
    title
    Placebo
  2. description
    Participants on background methotrexate therapy administered 1 x 1-mg baricitinib (LY3009104) capsule + 1 identical placebo capsule, orally once daily for 12 weeks.
    id
    EG001
    other Num Affected
    11
    other Num At Risk
    24
    serious Num Affected
    0
    serious Num At Risk
    24
    title
    1 mg Baricitinib (LY3009104)
  3. description
    Participants on background methotrexate therapy administered 2 x 1-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks.
    id
    EG002
    other Num Affected
    12
    other Num At Risk
    24
    serious Num Affected
    1
    serious Num At Risk
    24
    title
    2 mg Baricitinib (LY3009104)
  4. description
    Participants on background methotrexate therapy administered 1 x 4-mg baricitinib (LY3009104) capsule +1 identical placebo capsule, orally once daily for 12 weeks.
    id
    EG003
    other Num Affected
    13
    other Num At Risk
    24
    serious Num Affected
    0
    serious Num At Risk
    24
    title
    4 mg Baricitinib (LY3009104)
  5. description
    Participants on background methotrexate therapy administered 2 x 4-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks.
    id
    EG004
    other Num Affected
    17
    other Num At Risk
    24
    serious Num Affected
    1
    serious Num At Risk
    24
    title
    8 mg Baricitinib (LY3009104)
  6. description
    Participants on background methotrexate therapy who were administered placebo capsule, orally once daily for 12 weeks in Part A received 4 mg baricitinib (LY3009104) and 1 placebo tablet orally once daily for 52 weeks in Part B.
    id
    EG005
    other Num Affected
    21
    other Num At Risk
    24
    serious Num Affected
    1
    serious Num At Risk
    24
    title
    Placebo / 4 mg Baricitinib (LY3009104)
  7. description
    Participants on background methotrexate therapy who were administered 1 mg baricitinib (LY3009104) capsule, orally once daily for 12 weeks in Part A received 4 mg baricitinib (LY3009104) and 1 placebo tablet orally once daily for 52 weeks in Part B.
    id
    EG006
    other Num Affected
    11
    other Num At Risk
    12
    serious Num Affected
    1
    serious Num At Risk
    12
    title
    1 mg Baricitinib (LY3009104) / 4mg Baricitinib (LY3009104)
  8. description
    Participants on background methotrexate therapy who were administered 2 mg baricitinib (LY3009104) capsule, orally once daily for 12 weeks in Part A received 4 mg baricitinib (LY3009104) and 1 placebo tablet orally once daily for 52 weeks in Part B.
    id
    EG007
    other Num Affected
    11
    other Num At Risk
    12
    serious Num Affected
    3
    serious Num At Risk
    12
    title
    2 mg Baricitinib (LY3009104) / 4 mg Baricitinib (LY3009104)
  9. description
    Participants on background methotrexate therapy who were administered 4 mg baricitinib (LY3009104) capsule, orally once daily for 12 weeks in Part A received 4 mg baricitinib (LY3009104) and 1 placebo tablet orally once daily for 52 weeks in Part B.
    id
    EG008
    other Num Affected
    22
    other Num At Risk
    23
    serious Num Affected
    3
    serious Num At Risk
    23
    title
    4 mg Baricitinib (LY3009104) / 4 mg Baricitinib (LY3009104)
  10. description
    Participants on background methotrexate therapy who were administered placebo capsule, orally once daily for 12 weeks in Part A received 2 x 4 mg baricitinib (LY3009104) tablets orally once daily for 52 weeks in Part B.
    id
    EG009
    other Num Affected
    23
    other Num At Risk
    23
    serious Num Affected
    2
    serious Num At Risk
    23
    title
    Placebo /8 mg Baricitinib (LY3009104)
  11. description
    Participants on background methotrexate therapy who were administered 1 mg baricitinib (LY3009104) capsule, orally once daily for 12 weeks in Part A received 2 x 4 mg baricitinib (LY3009104) tablets orally once daily for 52 weeks in Part B.
    id
    EG010
    other Num Affected
    11
    other Num At Risk
    11
    serious Num Affected
    2
    serious Num At Risk
    11
    title
    1 mg Baricitinib (LY3009104) / 8 mg Baricitinib (LY3009104)
  12. description
    Participants on background methotrexate therapy who were administered 2 mg baricitinib (LY3009104) capsule, orally once daily for 12 weeks in Part A received 2 x 4 mg baricitinib (LY3009104) tablets orally once daily for 52 weeks in Part B.
    id
    EG011
    other Num Affected
    12
    other Num At Risk
    12
    serious Num Affected
    2
    serious Num At Risk
    12
    title
    2 mg Baricitinib (LY3009104) / 8 mg Baricitinib (LY3009104)
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      49
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      24
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      24
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      24
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      12
      num Events
      1
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      23
      num Events
      2
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      23
      num Events
      1
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      11
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      49
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      24
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      23
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      23
      num Events
      2
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      11
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Haemorrhagic anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      49
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      24
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      23
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      23
      num Events
      0
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      11
      num Events
      1
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Iron deficiency anaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      49
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      24
      num Events
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      24
      num Events
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      23
      num Events
      0
    10. group Id
      EG009
      num Affected
      3
      num At Risk
      23
      num Events
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      11
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      24
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      24
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      24
      num Events
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      24
      num Events
      1
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      12
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    9. group Id
      EG008
      num Affected
      3
      num At Risk
      23
      num Events
      4
    10. group Id
      EG009
      num Affected
      3
      num At Risk
      23
      num Events
      4
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      11
      num Events
      1
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Lymphopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      49
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      24
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      12
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      23
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      23
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      11
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Pancytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      49
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      24
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      23
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      23
      num Events
      1
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      11
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Arrhythmia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      49
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      24
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      23
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      23
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      11
      num Events
      0
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Bradycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      49
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      24
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      23
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      23
      num Events
      1
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      11
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Sinus tachycardia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      49
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      24
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      23
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      23
      num Events
      1
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      11
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Ventricular extrasystoles
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Congenital, familial and genetic disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      49
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      24
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      23
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      23
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      11
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Birth mark
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      49
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      24
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      23
      num Events
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      23
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      11
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Deafness neurosensory
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      49
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      24
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      23
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      23
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      11
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Angina pectoris
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      49
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      24
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      23
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      23
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      11
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Myocardial infarction
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      49
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      24
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      23
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      23
      num Events
      1
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      11
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Meniere's disease
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      49
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      24
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      24
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      23
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      23
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      11
      num Events
      0
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Cataract
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      49
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      24
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      12
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      23
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      23
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      11
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Large intestine polyp
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      49
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      24
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      24
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      12
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      23
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      23
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      11
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Pancreatitis acute
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      24
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      23
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      23
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      11
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Cholecystitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      49
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      24
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      23
      num Events
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      23
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      11
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Gastroenteritis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      49
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      24
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      12
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      23
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      23
      num Events
      0
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      11
      num Events
      1
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Herpes zoster
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      49
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      24
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      24
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      23
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      23
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      11
      num Events
      0
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Pneumocystis jirovecii pneumonia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      49
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      24
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      12
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      23
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      23
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      11
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Pneumonia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      49
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      24
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      12
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      23
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      23
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      11
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Clavicle fracture

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Preserved source evidence · Not medical advice