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NCT01721057 · ADVERSE EVENTS

Adverse events

A Study in Moderate to Severe Rheumatoid Arthritis Participants · Source last updated 2019-09-18

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
2%

All randomized participants who received at least 1 dose of study drug.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Placebo-Treatment Period

Placebo administered orally once daily through Week 24. Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.

13 / 228105 / 228Not reported / Not reported
Baricitinib 2 Mg-Treatment Period

Baricitinib 2 mg administered orally once daily through Week 24. Participants continued to take background cDMARD therapy throughout study.

6 / 229108 / 229Not reported / Not reported
Baricitinib 4 Mg-Treatment Period

Baricitinib 4 mg administered orally once daily through Week 24. Participants continued to take background cDMARD therapy throughout study.

12 / 227127 / 227Not reported / Not reported
Rescue

Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.

1 / 9121 / 91Not reported / Not reported
Placebo-Follow Up

No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.

1 / 172 / 17Not reported / Not reported
Baricitinib 2 mg- Follow Up

No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.

0 / 190 / 19Not reported / Not reported
Baricitinib 4 mg- Follow Up

No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug. Includes participants who were rescued to Baricitinib 4 mg.

1 / 224 / 22Not reported / Not reported

Group identifiers: EG000: Placebo-Treatment Period · EG001: Baricitinib 2 Mg-Treatment Period · EG002: Baricitinib 4 Mg-Treatment Period · EG003: Rescue · EG004: Placebo-Follow Up · EG005: Baricitinib 2 mg- Follow Up · EG006: Baricitinib 4 mg- 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 17.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      228
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      229
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      227
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      91
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      19
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      22
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      228
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      229
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      227
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      91
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      19
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      22
    term
    Angina pectoris
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      228
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      229
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      227
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      91
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      19
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      22
    term
    Atrial fibrillation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      228
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      229
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      227
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      91
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      19
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      22
    term
    Myocardial infarction
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      228
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      229
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      227
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      91
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      19
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      22
    term
    Ventricular tachycardia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      228
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      229
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      227
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      91
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      19
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      22
    term
    Diverticulum intestinal
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      228
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      229
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      227
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      91
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      19
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      22
    term
    Dyspepsia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      228
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      229
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      227
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      91
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      19
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      22
    term
    Gastrointestinal haemorrhage
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      228
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      229
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      227
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      91
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      19
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      22
    term
    Cholecystitis acute
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      229
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      227
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      91
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      17
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      19
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Appendicitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      228
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      229
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      227
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      91
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      19
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      22
    term
    Bacterial infection
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      228
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      229
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      227
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      91
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      19
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      22
    term
    Bronchitis

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 17.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      228
      num Events
      6
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      229
      num Events
      6
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      227
      num Events
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      91
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      19
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      22
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      229
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      227
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      91
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      19
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      22
      num Events
      1
    term
    Sinus bradycardia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      228
      num Events
      0
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      229
      num Events
      5
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      227
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      91
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      19
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      22
    term
    Abdominal pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      228
      num Events
      1
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      229
      num Events
      5
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      227
      num Events
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      91
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      19
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      22
    term
    Abdominal pain upper
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      228
      num Events
      4
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      229
      num Events
      7
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      227
      num Events
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      91
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      19
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      22
    term
    Constipation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      228
      num Events
      11
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      229
      num Events
      11
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      227
      num Events
      5
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      91
      num Events
      2
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      17
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      19
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Diarrhoea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      228
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      229
      num Events
      1
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      227
      num Events
      5
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      91
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      19
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      22
    term
    Dyspepsia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      229
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      227
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      91
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      19
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      22
      num Events
      1
    term
    Gastritis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      228
      num Events
      5
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      229
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      227
      num Events
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      91
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      19
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      22
    term
    Gastrooesophageal reflux disease
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      229
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      227
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      91
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      19
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      22
      num Events
      1
    term
    Lip disorder
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      228
      num Events
      0
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      229
      num Events
      6
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      227
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      91
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      19
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      22
    term
    Mouth ulceration
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      228
      num Events
      9
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      229
      num Events
      7
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      227
      num Events
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      91
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      19
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      22
    term
    Nausea
Complete source fields
description
All randomized participants who received at least 1 dose of study drug.
event Groups
  1. description
    Placebo administered orally once daily through Week 24. Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.
    id
    EG000
    other Num Affected
    105
    other Num At Risk
    228
    serious Num Affected
    13
    serious Num At Risk
    228
    title
    Placebo-Treatment Period
  2. description
    Baricitinib 2 mg administered orally once daily through Week 24. Participants continued to take background cDMARD therapy throughout study.
    id
    EG001
    other Num Affected
    108
    other Num At Risk
    229
    serious Num Affected
    6
    serious Num At Risk
    229
    title
    Baricitinib 2 Mg-Treatment Period
  3. description
    Baricitinib 4 mg administered orally once daily through Week 24. Participants continued to take background cDMARD therapy throughout study.
    id
    EG002
    other Num Affected
    127
    other Num At Risk
    227
    serious Num Affected
    12
    serious Num At Risk
    227
    title
    Baricitinib 4 Mg-Treatment Period
  4. description
    Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
    id
    EG003
    other Num Affected
    21
    other Num At Risk
    91
    serious Num Affected
    1
    serious Num At Risk
    91
    title
    Rescue
  5. description
    No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.
    id
    EG004
    other Num Affected
    2
    other Num At Risk
    17
    serious Num Affected
    1
    serious Num At Risk
    17
    title
    Placebo-Follow Up
  6. description
    No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.
    id
    EG005
    other Num Affected
    0
    other Num At Risk
    19
    serious Num Affected
    0
    serious Num At Risk
    19
    title
    Baricitinib 2 mg- Follow Up
  7. description
    No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug. Includes participants who were rescued to Baricitinib 4 mg.
    id
    EG006
    other Num Affected
    4
    other Num At Risk
    22
    serious Num Affected
    1
    serious Num At Risk
    22
    title
    Baricitinib 4 mg- Follow Up
frequency Threshold
2
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      228
      num Events
      6
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      229
      num Events
      6
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      227
      num Events
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      91
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      19
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      22
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      229
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      227
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      91
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      19
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      22
      num Events
      1
    term
    Sinus bradycardia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      228
      num Events
      0
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      229
      num Events
      5
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      227
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      91
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      19
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      22
    term
    Abdominal pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      228
      num Events
      1
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      229
      num Events
      5
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      227
      num Events
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      91
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      19
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      22
    term
    Abdominal pain upper
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      228
      num Events
      4
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      229
      num Events
      7
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      227
      num Events
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      91
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      19
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      22
    term
    Constipation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      228
      num Events
      11
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      229
      num Events
      11
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      227
      num Events
      5
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      91
      num Events
      2
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      17
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      19
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Diarrhoea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      228
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      229
      num Events
      1
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      227
      num Events
      5
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      91
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      19
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      22
    term
    Dyspepsia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      229
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      227
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      91
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      19
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      22
      num Events
      1
    term
    Gastritis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      228
      num Events
      5
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      229
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      227
      num Events
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      91
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      19
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      22
    term
    Gastrooesophageal reflux disease
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      229
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      227
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      91
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      19
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      22
      num Events
      1
    term
    Lip disorder
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      228
      num Events
      0
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      229
      num Events
      6
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      227
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      91
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      19
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      22
    term
    Mouth ulceration
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      228
      num Events
      9
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      229
      num Events
      7
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      227
      num Events
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      91
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      19
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      22
    term
    Nausea
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      228
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      229
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      227
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      91
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      19
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      22
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      228
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      229
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      227
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      91
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      19
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      22
    term
    Angina pectoris
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      228
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      229
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      227
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      91
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      19
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      22
    term
    Atrial fibrillation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      228
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      229
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      227
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      91
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      19
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      22
    term
    Myocardial infarction
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      228
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      229
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      227
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      91
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      19
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      22
    term
    Ventricular tachycardia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      228
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      229
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      227
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      91
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      19
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      22
    term
    Diverticulum intestinal
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      228
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      229
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      227
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      91
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      19
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      22
    term
    Dyspepsia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      228
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      229
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      227
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      91
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      19
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      22
    term
    Gastrointestinal haemorrhage
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      228
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      229
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      227
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      91
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      19
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      22
    term
    Cholecystitis acute
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      229
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      227
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      91
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      17
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      19
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Appendicitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      228
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      229
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      227
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      91
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      19
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      22
    term
    Bacterial infection
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      228
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      229
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      227
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      91
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      19
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      22
    term
    Bronchitis

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

Preserved source evidence · Not medical advice