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NCT01185353 · ADVERSE EVENTS

Adverse events

A Study in Participants With Rheumatoid Arthritis on Background Methotrexate Therapy · Source last updated 2017-06-16

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
4%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
1 mg LY3009104 QD - Part A

Administered orally QD for 12 weeks in Part A. MTX was administered orally as background therapy.

0 / 4915 / 49Not reported / Not reported
2 mg LY3009104 QD - Part A

Administered orally QD for 12 weeks in Part A. MTX was administered orally as background therapy.

3 / 5213 / 52Not reported / Not reported
4 mg LY3009104 QD - Part A

Administered orally QD for 12 weeks in Pat A. MTX was administered orally as background therapy.

2 / 5213 / 52Not reported / Not reported
8 mg LY3009104 QD - Part A

Administered orally QD for 12 weeks in Part A. MTX was administered orally as background therapy.

1 / 5015 / 50Not reported / Not reported
Placebo QD - Part A

Placebo administered orally QD for 12 weeks in Part A. MTX was administered orally as background therapy.

3 / 9818 / 98Not reported / Not reported
2 mg LY3009104 BID Crossover- Part B

Participants who received Placebo or 1 mg LY3009104 in Part A were re-randomized at Week 12 to receive 2 mg LY3009104 BID in Part B. MTX was administered orally as background therapy.

2 / 6315 / 63Not reported / Not reported
4 mg LY3009104 QD Crossover- Part B

Participants who received Placebo or 1 mg LY3009104 in Part A were re-randomized at Week 12 to receive 4 mg LY3009104 QD in Part B. MTX was administered orally as background therapy.

1 / 6310 / 63Not reported / Not reported
2 mg LY3009104 QD - Part B

Participants who received 2 mg LY3009104 QD in Part A continued to receive 2 mg LY3009104 QD in Part B. MTX was administered orally as background therapy.

0 / 5112 / 51Not reported / Not reported
4 mg LY3009104 QD - Part B

Participants who received 4 mg LY3009104 QD in Part A continued to receive 4 mg LY3009104 QD in Part B. MTX was administered orally as background therapy.

0 / 5010 / 50Not reported / Not reported
8 mg LY3009104 QD - Part B

Participants who received 8 mg LY3009104 QD in Part A continued to receive 8 mg LY3009104 QD in Part B. MTX was administered orally as background therapy.

3 / 4918 / 49Not reported / Not reported
4 mg LY3009104 QD - Part C

Participants who received 2 mg LY3009104 QD or BID in Part B were re-assigned at Week 24 to 4 mg LY3009104 QD in Part C. Participants who received 4 mg LY3009104 QD in Part B continued to receive 4 mg LY3009104 QD in Part C. MTX was administered orally as background therapy.

16 / 10835 / 108Not reported / Not reported
4 to 8 mg LY3009104 QD Pre-Rescue - Part C

Participants who received 2 mg LY3009104 QD or BID in Part B were re-assigned at Week 24 to 4 mg LY3009104 QD in Part C. Participants who received 4 mg LY3009104 QD in Part B continued to receive 4 mg LY3009104 QD in Part C. During Part C, at Weeks 28 and 32, participants who met dose escalation criteria received 8 mg LY3009104 QD (rescue treatment) for the rest of the Part C. MTX was administered orally as background therapy. Adverse events were collected from Week 24 until predose of 8 mg LY3009104 QD.

1 / 617 / 61Not reported / Not reported
4 to 8 mg LY3009104 QD Post-Rescue - Part C

Participants who received 2 mg LY3009104 QD or BID in Part B were re-assigned at Week 24 to 4 mg LY3009104 QD in Part C. Participants who received 4 mg LY3009104 QD in Part B continued to receive 4 mg LY3009104 QD in Part C. During Part C, at Weeks 28 and 32, participants who met dose escalation criteria received 8 mg LY3009104 QD (rescue treatment) for the rest of the Part C. MTX was administered orally as background therapy. Adverse events were collected from predose of 8 mg LY3009104 QD until Week 76.

6 / 6125 / 61Not reported / Not reported
8 mg LY3009104 QD - Part C

Participants who received 8 mg LY3009104 QD in Part B remained on 8 mg LY3009104 QD in Part C. MTX was administered orally as background therapy.

6 / 3216 / 32Not reported / Not reported
4 mg LY3009104 QD - Part D

Participants who received 4 mg LY3009104 QD in Part C continued to receive 4 mg LY3009104 QD in Part D. MTX was administered orally as background therapy.

5 / 7924 / 79Not reported / Not reported
4 mg LY3009104 QD (4 to 8 mg Rescue)- Part D

Participants who received 8 mg LY3009104 QD rescue treatment in Part C received 4 mg LY3009104 QD in Part D. MTX was administered orally as background therapy.

3 / 4713 / 47Not reported / Not reported
8/4 mg LY3009104 QD - Part D

Participants who received 8 mg LY3009104 QD in Part C received 4 mg LY3009104 QD in Part D. MTX was administered orally as background therapy.

0 / 1810 / 18Not reported / Not reported
Follow-Up

Up to 28 days post the last dose of study drug. MTX was administered orally as background therapy.

2 / 1595 / 159Not reported / Not reported

Group identifiers: EG000: 1 mg LY3009104 QD - Part A · EG001: 2 mg LY3009104 QD - Part A · EG002: 4 mg LY3009104 QD - Part A · EG003: 8 mg LY3009104 QD - Part A · EG004: Placebo QD - Part A · EG005: 2 mg LY3009104 BID Crossover- Part B · EG006: 4 mg LY3009104 QD Crossover- Part B · EG007: 2 mg LY3009104 QD - Part B · EG008: 4 mg LY3009104 QD - Part B · EG009: 8 mg LY3009104 QD - Part B · EG010: 4 mg LY3009104 QD - Part C · EG011: 4 to 8 mg LY3009104 QD Pre-Rescue - Part C · EG012: 4 to 8 mg LY3009104 QD Post-Rescue - Part C · EG013: 8 mg LY3009104 QD - Part C · EG014: 4 mg LY3009104 QD - Part D · EG015: 4 mg LY3009104 QD (4 to 8 mg Rescue)- Part D · EG016: 8/4 mg LY3009104 QD - Part D · EG017: Follow-Up

Serious adverse events

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

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 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
      52
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      50
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      98
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      63
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      63
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      51
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      50
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      49
      num Events
      0
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      108
      num Events
      1
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
      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
      52
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      50
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      98
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      63
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      63
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      51
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      50
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      49
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      108
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
      num Events
      0
    term
    Microcytic 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
      52
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      50
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      98
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      63
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      63
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      51
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      50
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      49
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      108
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
      num Events
      0
    term
    Normochromic normocytic 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
      52
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      50
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      98
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      63
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      63
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      51
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      50
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      49
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      108
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
      num Events
      0
    term
    Pancytopenia
  5. 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
      52
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      50
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      98
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      63
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      63
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      51
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      50
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      49
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      108
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
      num Events
      0
    term
    Myocardial infarction
  6. 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
      52
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      50
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      98
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      63
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      63
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      51
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      50
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      49
      num Events
      0
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      108
      num Events
      1
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
      num Events
      0
    term
    Cataract
  7. 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
      52
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      50
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      98
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      63
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      63
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      51
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      50
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      49
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      108
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
      num Events
      0
    term
    Ulcerative keratitis
  8. 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
      52
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      50
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      98
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      63
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      63
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      51
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      50
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      49
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      108
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
      num Events
      0
    term
    Coeliac disease
  9. 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
      52
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      50
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      98
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      63
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      63
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      51
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      50
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      49
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      108
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
      num Events
      0
    term
    Colitis
  10. 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
      52
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      50
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      98
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      63
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      63
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      51
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      50
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      49
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      108
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
      num Events
      0
    term
    Gastritis
  11. 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
      52
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      50
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      98
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      63
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      63
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      51
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      50
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      49
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      108
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
      num Events
      0
    term
    Large intestinal obstruction
  12. 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
      52
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      50
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      98
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      63
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      63
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      51
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      50
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      49
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      108
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
      num Events
      0
    term
    Large intestinal stenosis

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
      0
      num At Risk
      52
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      52
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      50
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      98
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      63
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      63
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      51
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      50
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      49
      num Events
      1
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      108
      num Events
      0
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      61
      num Events
      1
    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
      52
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      50
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      98
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      63
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      63
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      51
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      50
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      49
      num Events
      1
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      108
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
      num Events
      0
    term
    Leukopenia
  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
      52
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      50
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      98
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      63
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      63
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      51
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      50
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      49
      num Events
      1
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      108
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
      num Events
      0
    term
    Neutropenia
  4. 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
      1
      num At Risk
      52
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      50
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      98
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      63
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      63
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      51
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      50
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      49
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      108
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
      num Events
      0
    term
    Abdominal discomfort
  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
      1
      num At Risk
      52
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      50
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      98
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      63
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      63
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      51
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      50
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      49
      num Events
      1
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      108
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
      num Events
      0
    term
    Abdominal pain
  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
      52
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      50
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      98
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      63
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      63
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      51
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      50
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      49
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      108
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
      num Events
      0
    term
    Acquired oesophageal web
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      49
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      52
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      50
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      98
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      63
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      63
      num Events
      2
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      51
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      50
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      49
      num Events
      1
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      108
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
      num Events
      0
    term
    Dyspepsia
  8. 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
      52
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      50
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      98
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      63
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      63
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      51
      num Events
      1
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      50
      num Events
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      49
      num Events
      0
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      108
      num Events
      1
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
      num Events
      0
    term
    Gastritis
  9. 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
      52
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      50
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      98
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      63
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      63
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      51
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      50
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      49
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      108
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
      num Events
      0
    term
    Haemorrhoids
  10. 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
      52
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      50
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      98
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      63
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      63
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      51
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      50
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      49
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      108
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
      num Events
      0
    term
    Irritable bowel syndrome
  11. 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
      52
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      50
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      98
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      63
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      63
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      51
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      50
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      49
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      108
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
      num Events
      0
    term
    Oesophagitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      49
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      52
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      50
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      98
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      63
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      63
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      51
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      50
      num Events
      1
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      49
      num Events
      1
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      108
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
      num Events
      0
    term
    Oedema peripheral
Complete source fields
event Groups
  1. description
    Administered orally QD for 12 weeks in Part A. MTX was administered orally as background therapy.
    id
    EG000
    other Num Affected
    15
    other Num At Risk
    49
    serious Num Affected
    0
    serious Num At Risk
    49
    title
    1 mg LY3009104 QD - Part A
  2. description
    Administered orally QD for 12 weeks in Part A. MTX was administered orally as background therapy.
    id
    EG001
    other Num Affected
    13
    other Num At Risk
    52
    serious Num Affected
    3
    serious Num At Risk
    52
    title
    2 mg LY3009104 QD - Part A
  3. description
    Administered orally QD for 12 weeks in Pat A. MTX was administered orally as background therapy.
    id
    EG002
    other Num Affected
    13
    other Num At Risk
    52
    serious Num Affected
    2
    serious Num At Risk
    52
    title
    4 mg LY3009104 QD - Part A
  4. description
    Administered orally QD for 12 weeks in Part A. MTX was administered orally as background therapy.
    id
    EG003
    other Num Affected
    15
    other Num At Risk
    50
    serious Num Affected
    1
    serious Num At Risk
    50
    title
    8 mg LY3009104 QD - Part A
  5. description
    Placebo administered orally QD for 12 weeks in Part A. MTX was administered orally as background therapy.
    id
    EG004
    other Num Affected
    18
    other Num At Risk
    98
    serious Num Affected
    3
    serious Num At Risk
    98
    title
    Placebo QD - Part A
  6. description
    Participants who received Placebo or 1 mg LY3009104 in Part A were re-randomized at Week 12 to receive 2 mg LY3009104 BID in Part B. MTX was administered orally as background therapy.
    id
    EG005
    other Num Affected
    15
    other Num At Risk
    63
    serious Num Affected
    2
    serious Num At Risk
    63
    title
    2 mg LY3009104 BID Crossover- Part B
  7. description
    Participants who received Placebo or 1 mg LY3009104 in Part A were re-randomized at Week 12 to receive 4 mg LY3009104 QD in Part B. MTX was administered orally as background therapy.
    id
    EG006
    other Num Affected
    10
    other Num At Risk
    63
    serious Num Affected
    1
    serious Num At Risk
    63
    title
    4 mg LY3009104 QD Crossover- Part B
  8. description
    Participants who received 2 mg LY3009104 QD in Part A continued to receive 2 mg LY3009104 QD in Part B. MTX was administered orally as background therapy.
    id
    EG007
    other Num Affected
    12
    other Num At Risk
    51
    serious Num Affected
    0
    serious Num At Risk
    51
    title
    2 mg LY3009104 QD - Part B
  9. description
    Participants who received 4 mg LY3009104 QD in Part A continued to receive 4 mg LY3009104 QD in Part B. MTX was administered orally as background therapy.
    id
    EG008
    other Num Affected
    10
    other Num At Risk
    50
    serious Num Affected
    0
    serious Num At Risk
    50
    title
    4 mg LY3009104 QD - Part B
  10. description
    Participants who received 8 mg LY3009104 QD in Part A continued to receive 8 mg LY3009104 QD in Part B. MTX was administered orally as background therapy.
    id
    EG009
    other Num Affected
    18
    other Num At Risk
    49
    serious Num Affected
    3
    serious Num At Risk
    49
    title
    8 mg LY3009104 QD - Part B
  11. description
    Participants who received 2 mg LY3009104 QD or BID in Part B were re-assigned at Week 24 to 4 mg LY3009104 QD in Part C. Participants who received 4 mg LY3009104 QD in Part B continued to receive 4 mg LY3009104 QD in Part C. MTX was administered orally as background therapy.
    id
    EG010
    other Num Affected
    35
    other Num At Risk
    108
    serious Num Affected
    16
    serious Num At Risk
    108
    title
    4 mg LY3009104 QD - Part C
  12. description
    Participants who received 2 mg LY3009104 QD or BID in Part B were re-assigned at Week 24 to 4 mg LY3009104 QD in Part C. Participants who received 4 mg LY3009104 QD in Part B continued to receive 4 mg LY3009104 QD in Part C. During Part C, at Weeks 28 and 32, participants who met dose escalation criteria received 8 mg LY3009104 QD (rescue treatment) for the rest of the Part C. MTX was administered orally as background therapy. Adverse events were collected from Week 24 until predose of 8 mg LY3009104 QD.
    id
    EG011
    other Num Affected
    7
    other Num At Risk
    61
    serious Num Affected
    1
    serious Num At Risk
    61
    title
    4 to 8 mg LY3009104 QD Pre-Rescue - Part C
frequency Threshold
4
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
      0
      num At Risk
      52
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      52
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      50
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      98
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      63
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      63
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      51
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      50
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      49
      num Events
      1
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      108
      num Events
      0
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      61
      num Events
      1
    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
      52
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      50
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      98
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      63
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      63
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      51
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      50
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      49
      num Events
      1
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      108
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
      num Events
      0
    term
    Leukopenia
  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
      52
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      50
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      98
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      63
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      63
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      51
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      50
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      49
      num Events
      1
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      108
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
      num Events
      0
    term
    Neutropenia
  4. 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
      1
      num At Risk
      52
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      50
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      98
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      63
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      63
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      51
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      50
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      49
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      108
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
      num Events
      0
    term
    Abdominal discomfort
  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
      1
      num At Risk
      52
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      50
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      98
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      63
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      63
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      51
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      50
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      49
      num Events
      1
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      108
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
      num Events
      0
    term
    Abdominal pain
  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
      52
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      50
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      98
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      63
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      63
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      51
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      50
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      49
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      108
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
      num Events
      0
    term
    Acquired oesophageal web
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      49
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      52
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      50
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      98
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      63
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      63
      num Events
      2
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      51
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      50
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      49
      num Events
      1
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      108
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
      num Events
      0
    term
    Dyspepsia
  8. 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
      52
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      50
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      98
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      63
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      63
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      51
      num Events
      1
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      50
      num Events
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      49
      num Events
      0
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      108
      num Events
      1
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
      num Events
      0
    term
    Gastritis
  9. 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
      52
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      50
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      98
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      63
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      63
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      51
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      50
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      49
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      108
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
      num Events
      0
    term
    Haemorrhoids
  10. 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
      52
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      50
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      98
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      63
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      63
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      51
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      50
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      49
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      108
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
      num Events
      0
    term
    Irritable bowel syndrome
  11. 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
      52
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      50
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      98
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      63
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      63
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      51
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      50
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      49
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      108
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
      num Events
      0
    term
    Oesophagitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      49
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      52
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      50
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      98
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      63
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      63
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      51
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      50
      num Events
      1
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      49
      num Events
      1
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      108
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
      num Events
      0
    term
    Oedema peripheral
serious 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
      0
      num At Risk
      52
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      50
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      98
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      63
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      63
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      51
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      50
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      49
      num Events
      0
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      108
      num Events
      1
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
      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
      52
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      50
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      98
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      63
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      63
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      51
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      50
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      49
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      108
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
      num Events
      0
    term
    Microcytic 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
      52
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      50
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      98
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      63
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      63
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      51
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      50
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      49
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      108
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
      num Events
      0
    term
    Normochromic normocytic 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
      52
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      50
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      98
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      63
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      63
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      51
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      50
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      49
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      108
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
      num Events
      0
    term
    Pancytopenia
  5. 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
      52
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      50
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      98
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      63
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      63
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      51
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      50
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      49
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      108
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
      num Events
      0
    term
    Myocardial infarction
  6. 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
      52
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      50
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      98
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      63
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      63
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      51
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      50
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      49
      num Events
      0
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      108
      num Events
      1
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
      num Events
      0
    term
    Cataract
  7. 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
      52
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      50
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      98
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      63
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      63
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      51
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      50
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      49
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      108
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
      num Events
      0
    term
    Ulcerative keratitis
  8. 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
      52
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      50
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      98
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      63
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      63
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      51
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      50
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      49
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      108
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
      num Events
      0
    term
    Coeliac disease
  9. 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
      52
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      50
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      98
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      63
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      63
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      51
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      50
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      49
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      108
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
      num Events
      0
    term
    Colitis
  10. 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
      52
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      50
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      98
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      63
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      63
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      51
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      50
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      49
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      108
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
      num Events
      0
    term
    Gastritis
  11. 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
      52
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      50
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      98
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      63
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      63
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      51
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      50
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      49
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      108
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
      num Events
      0
    term
    Large intestinal obstruction
  12. 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
      52
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      50
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      98
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      63
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      63
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      51
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      50
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      49
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      108
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
      num Events
      0
    term
    Large intestinal stenosis

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Preserved source evidence · Not medical advice