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NCT02059291 · ADVERSE EVENTS

Adverse events

Study of Efficacy and Safety of Canakinumab in Patients With Hereditary Periodic Fevers · Source last updated 2018-05-17

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
up to week 112
Other-event reporting threshold
5%

Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Non-randomized Open Label crFMF, HIDS/MKD Patients

Canakinumab-naïve Japanese patients with non-exon 10 mutations with cr-FMF who received open-label canakinumab 150 mg (or 2 mg/kg for patients weighing ≤ 40 kg) q4w; and patients in the 28 days to less than 2 years old cohort with HIDS/MKD who received open-label canakinumab 150 mg (or 2mg/kg for patients weighing ≤ 40 kg) q4w

3 / 44 / 40 / 4
Non-randomized Open Label TRAPS Patients

Open-label treatment in Epoch 3 was initiated for TRAPS patients who rolled over from CACZ885D2203 or CACZ885D2207M

1 / 1818 / 180 / 18
Randomized ACZ and Placebo TRAPS Patients - Placebo Events

Patients who received ACZ885 and/or placebo during epoch 2 and/or epoch 3.

1 / 4614 / 460 / 46
Randomized ACZ and Placebo TRAPS Pts - No Medication Events

Patients who received ACZ885 and/or placebo during epoch 2 and/or epoch 3 .

0 / 461 / 460 / 46
Randomized ACZ and Placebo TRAPS Patients - ACZ Events

Patients who received ACZ885 and/or placebo during epoch 2 and/or epoch 3

8 / 4643 / 460 / 46
Randomized ACZ and Placebo HIDS/MKD Pts - Placebo Events

Patients who received ACZ885 and/or placebo during epoch 2 and/or epoch 3

6 / 7225 / 720 / 72
Randomized ACZ and Placebo HIDS/MKD Pts - No Medication Events

Patients who received ACZ885 and/or placebo during epoch 2 and/or epoch 3

1 / 721 / 720 / 72
Randomized ACZ and Placebo HIDS/MKD Patients - ACZ Events

Patients who received ACZ885 and/or placebo during epoch 2 and/or epoch 3

16 / 7268 / 720 / 72
Randomized ACZ and Placebo crFMF Patients - Placebo Events

Patients who received ACZ885 and/or placebo during epoch 2 and/or epoch 3

5 / 6329 / 630 / 63
Randomized ACZ and Placebo crFMF Pts - No Medication Events

Patients who received ACZ885 and/or placebo during epoch 2 and/or epoch 3

0 / 632 / 630 / 63
Randomized ACZ and Placebo crFMF Patients - ACZ Events

Patients who received ACZ885 and/or placebo during epoch 2 and/or epoch 3

16 / 6354 / 630 / 63
Any ACZ TRAPS Patients - Placebo Events

Patients who received ACZ885 during epoch 2 and/or epoch 3

0 / 614 / 610 / 61
Any ACZ TRAPS Patients - no Medication Events

Patients who received ACZ885 during epoch 2 and/or epoch 3

0 / 611 / 610 / 61
Any ACZ TRAPS Patients - ACZ Events

Patients who received ACZ885 during epoch 2 and/or epoch 3

9 / 6161 / 610 / 61
Any ACZ HIDS/MKD Patients - Placebo Events

Patients who received ACZ885 during epoch 2 and/or epoch 3

3 / 717 / 710 / 71
Any ACZ HIDS/MKD Patients - No Medication Events

Patients who received ACZ885 during epoch 2 and/or epoch 3

1 / 711 / 710 / 71
Any ACZ HIDS/MKD Patients - ACZ Events

Patients who received ACZ885 during epoch 2 and/or epoch 3

18 / 7170 / 710 / 71
Any ACZ crFMF Patients - Placebo Events

Patients who received ACZ885 during epoch 2 and/or epoch 3

3 / 6110 / 610 / 61
Any ACZ crFMF Patients - No Medication Events

Patients who received ACZ885 during epoch 2 and/or epoch 3

0 / 612 / 610 / 61
Any ACZ crFMF Patients - ACZ Events

Patients who received ACZ885 during epoch 2 and/or epoch 3

17 / 6156 / 610 / 61

Group identifiers: EG000: Non-randomized Open Label crFMF, HIDS/MKD Patients · EG001: Non-randomized Open Label TRAPS Patients · EG002: Randomized ACZ and Placebo TRAPS Patients - Placebo Events · EG003: Randomized ACZ and Placebo TRAPS Pts - No Medication Events · EG004: Randomized ACZ and Placebo TRAPS Patients - ACZ Events · EG005: Randomized ACZ and Placebo HIDS/MKD Pts - Placebo Events · EG006: Randomized ACZ and Placebo HIDS/MKD Pts - No Medication Events · EG007: Randomized ACZ and Placebo HIDS/MKD Patients - ACZ Events · EG008: Randomized ACZ and Placebo crFMF Patients - Placebo Events · EG009: Randomized ACZ and Placebo crFMF Pts - No Medication Events · EG010: Randomized ACZ and Placebo crFMF Patients - ACZ Events · EG011: Any ACZ TRAPS Patients - Placebo Events · EG012: Any ACZ TRAPS Patients - no Medication Events · EG013: Any ACZ TRAPS Patients - ACZ Events · EG014: Any ACZ HIDS/MKD Patients - Placebo Events · EG015: Any ACZ HIDS/MKD Patients - No Medication Events · EG016: Any ACZ HIDS/MKD Patients - ACZ Events · EG017: Any ACZ crFMF Patients - Placebo Events · EG018: Any ACZ crFMF Patients - No Medication Events · EG019: Any ACZ crFMF Patients - ACZ Events

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 (20.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      46
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      72
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      72
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      72
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      63
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      63
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      63
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      46
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      72
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      72
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      72
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      63
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      63
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      63
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
    term
    Lymphadenopathy
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      46
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      72
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      72
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      72
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      63
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      63
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      63
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      46
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      72
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      72
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      72
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      63
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      63
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      63
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
    term
    Pancytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      46
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      72
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      72
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      72
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      63
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      63
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      63
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
    term
    Cardiac failure congestive
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      46
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      72
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      72
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      72
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      63
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      63
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      63
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
    term
    Pericarditis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Congenital, familial and genetic disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      46
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      72
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      72
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      72
    9. group Id
      EG008
      num Affected
      3
      num At Risk
      63
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      63
    11. group Id
      EG010
      num Affected
      2
      num At Risk
      63
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
    term
    Familial mediterranean fever
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Congenital, familial and genetic disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      46
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      72
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      72
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      72
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      63
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      63
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      63
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
    term
    Hyper IgD syndrome
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Congenital, familial and genetic disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      46
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      72
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      72
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      72
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      63
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      63
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      63
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
    term
    Tumour necrosis factor receptor-associated periodic syndrome
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      46
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      72
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      72
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      72
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      63
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      63
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      63
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
    term
    Thyroiditis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      46
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      72
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      72
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      72
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      63
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      63
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      63
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
    term
    Abdominal pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      46
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      72
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      72
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      72
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      63
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      63
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      63
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
    term
    Ascites

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 (20.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      46
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      72
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      72
    8. group Id
      EG007
      num Affected
      4
      num At Risk
      72
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      63
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      63
    11. group Id
      EG010
      num Affected
      3
      num At Risk
      63
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      46
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      72
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      72
    8. group Id
      EG007
      num Affected
      18
      num At Risk
      72
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      63
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      63
    11. group Id
      EG010
      num Affected
      5
      num At Risk
      63
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
    term
    Lymphadenopathy
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      46
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      72
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      72
    8. group Id
      EG007
      num Affected
      4
      num At Risk
      72
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      63
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      63
    11. group Id
      EG010
      num Affected
      3
      num At Risk
      63
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      46
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      72
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      72
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      72
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      63
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      63
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      63
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
    term
    Atrial fibrillation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      46
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      72
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      72
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      72
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      63
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      63
    11. group Id
      EG010
      num Affected
      2
      num At Risk
      63
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
    term
    Tachycardia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Congenital, familial and genetic disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      46
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      72
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      72
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      72
    9. group Id
      EG008
      num Affected
      15
      num At Risk
      63
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      63
    11. group Id
      EG010
      num Affected
      19
      num At Risk
      63
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
    term
    Familial mediterranean fever
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Congenital, familial and genetic disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      46
    6. group Id
      EG005
      num Affected
      5
      num At Risk
      72
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      72
    8. group Id
      EG007
      num Affected
      19
      num At Risk
      72
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      63
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      63
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      63
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
    term
    Hyper IgD syndrome
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Congenital, familial and genetic disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
    5. group Id
      EG004
      num Affected
      6
      num At Risk
      46
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      72
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      72
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      72
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      63
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      63
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      63
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
    term
    Tumour necrosis factor receptor-associated periodic syndrome
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      46
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      72
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      72
    8. group Id
      EG007
      num Affected
      10
      num At Risk
      72
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      63
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      63
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      63
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
    term
    Ear pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      46
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      72
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      72
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      72
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      63
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      63
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      63
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
    term
    Hyperthyroidism
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      46
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      72
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      72
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      72
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      63
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      63
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      63
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
    term
    Eye allergy
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      46
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      72
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      72
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      72
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      63
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      63
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      63
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
    term
    Eye pain
Complete source fields
description
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    4
    description
    Canakinumab-naïve Japanese patients with non-exon 10 mutations with cr-FMF who received open-label canakinumab 150 mg (or 2 mg/kg for patients weighing ≤ 40 kg) q4w; and patients in the 28 days to less than 2 years old cohort with HIDS/MKD who received open-label canakinumab 150 mg (or 2mg/kg for patients weighing ≤ 40 kg) q4w
    id
    EG000
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    3
    serious Num At Risk
    4
    title
    Non-randomized Open Label crFMF, HIDS/MKD Patients
  2. deaths Num Affected
    0
    deaths Num At Risk
    18
    description
    Open-label treatment in Epoch 3 was initiated for TRAPS patients who rolled over from CACZ885D2203 or CACZ885D2207M
    id
    EG001
    other Num Affected
    18
    other Num At Risk
    18
    serious Num Affected
    1
    serious Num At Risk
    18
    title
    Non-randomized Open Label TRAPS Patients
  3. deaths Num Affected
    0
    deaths Num At Risk
    46
    description
    Patients who received ACZ885 and/or placebo during epoch 2 and/or epoch 3.
    id
    EG002
    other Num Affected
    14
    other Num At Risk
    46
    serious Num Affected
    1
    serious Num At Risk
    46
    title
    Randomized ACZ and Placebo TRAPS Patients - Placebo Events
  4. deaths Num Affected
    0
    deaths Num At Risk
    46
    description
    Patients who received ACZ885 and/or placebo during epoch 2 and/or epoch 3 .
    id
    EG003
    other Num Affected
    1
    other Num At Risk
    46
    serious Num Affected
    0
    serious Num At Risk
    46
    title
    Randomized ACZ and Placebo TRAPS Pts - No Medication Events
  5. deaths Num Affected
    0
    deaths Num At Risk
    46
    description
    Patients who received ACZ885 and/or placebo during epoch 2 and/or epoch 3
    id
    EG004
    other Num Affected
    43
    other Num At Risk
    46
    serious Num Affected
    8
    serious Num At Risk
    46
    title
    Randomized ACZ and Placebo TRAPS Patients - ACZ Events
  6. deaths Num Affected
    0
    deaths Num At Risk
    72
    description
    Patients who received ACZ885 and/or placebo during epoch 2 and/or epoch 3
    id
    EG005
    other Num Affected
    25
    other Num At Risk
    72
    serious Num Affected
    6
    serious Num At Risk
    72
    title
    Randomized ACZ and Placebo HIDS/MKD Pts - Placebo Events
  7. deaths Num Affected
    0
    deaths Num At Risk
    72
    description
    Patients who received ACZ885 and/or placebo during epoch 2 and/or epoch 3
    id
    EG006
    other Num Affected
    1
    other Num At Risk
    72
    serious Num Affected
    1
    serious Num At Risk
    72
    title
    Randomized ACZ and Placebo HIDS/MKD Pts - No Medication Events
  8. deaths Num Affected
    0
    deaths Num At Risk
    72
    description
    Patients who received ACZ885 and/or placebo during epoch 2 and/or epoch 3
    id
    EG007
    other Num Affected
    68
    other Num At Risk
    72
    serious Num Affected
    16
    serious Num At Risk
    72
    title
    Randomized ACZ and Placebo HIDS/MKD Patients - ACZ Events
  9. deaths Num Affected
    0
    deaths Num At Risk
    63
    description
    Patients who received ACZ885 and/or placebo during epoch 2 and/or epoch 3
    id
    EG008
    other Num Affected
    29
    other Num At Risk
    63
    serious Num Affected
    5
    serious Num At Risk
    63
    title
    Randomized ACZ and Placebo crFMF Patients - Placebo Events
  10. deaths Num Affected
    0
    deaths Num At Risk
    63
    description
    Patients who received ACZ885 and/or placebo during epoch 2 and/or epoch 3
    id
    EG009
    other Num Affected
    2
    other Num At Risk
    63
    serious Num Affected
    0
    serious Num At Risk
    63
    title
    Randomized ACZ and Placebo crFMF Pts - No Medication Events
  11. deaths Num Affected
    0
    deaths Num At Risk
    63
    description
    Patients who received ACZ885 and/or placebo during epoch 2 and/or epoch 3
    id
    EG010
    other Num Affected
    54
    other Num At Risk
    63
    serious Num Affected
    16
    serious Num At Risk
    63
    title
    Randomized ACZ and Placebo crFMF Patients - ACZ Events
  12. deaths Num Affected
    0
    deaths Num At Risk
    61
    description
    Patients who received ACZ885 during epoch 2 and/or epoch 3
    id
    EG011
    other Num Affected
    4
    other Num At Risk
    61
    serious Num Affected
    0
    serious Num At Risk
    61
    title
    Any ACZ TRAPS Patients - Placebo Events
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      46
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      72
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      72
    8. group Id
      EG007
      num Affected
      4
      num At Risk
      72
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      63
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      63
    11. group Id
      EG010
      num Affected
      3
      num At Risk
      63
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      46
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      72
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      72
    8. group Id
      EG007
      num Affected
      18
      num At Risk
      72
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      63
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      63
    11. group Id
      EG010
      num Affected
      5
      num At Risk
      63
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
    term
    Lymphadenopathy
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      46
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      72
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      72
    8. group Id
      EG007
      num Affected
      4
      num At Risk
      72
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      63
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      63
    11. group Id
      EG010
      num Affected
      3
      num At Risk
      63
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      46
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      72
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      72
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      72
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      63
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      63
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      63
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
    term
    Atrial fibrillation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      46
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      72
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      72
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      72
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      63
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      63
    11. group Id
      EG010
      num Affected
      2
      num At Risk
      63
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
    term
    Tachycardia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Congenital, familial and genetic disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      46
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      72
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      72
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      72
    9. group Id
      EG008
      num Affected
      15
      num At Risk
      63
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      63
    11. group Id
      EG010
      num Affected
      19
      num At Risk
      63
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
    term
    Familial mediterranean fever
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Congenital, familial and genetic disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      46
    6. group Id
      EG005
      num Affected
      5
      num At Risk
      72
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      72
    8. group Id
      EG007
      num Affected
      19
      num At Risk
      72
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      63
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      63
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      63
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
    term
    Hyper IgD syndrome
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Congenital, familial and genetic disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
    5. group Id
      EG004
      num Affected
      6
      num At Risk
      46
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      72
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      72
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      72
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      63
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      63
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      63
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
    term
    Tumour necrosis factor receptor-associated periodic syndrome
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      46
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      72
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      72
    8. group Id
      EG007
      num Affected
      10
      num At Risk
      72
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      63
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      63
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      63
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
    term
    Ear pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      46
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      72
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      72
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      72
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      63
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      63
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      63
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
    term
    Hyperthyroidism
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      46
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      72
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      72
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      72
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      63
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      63
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      63
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
    term
    Eye allergy
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      46
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      72
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      72
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      72
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      63
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      63
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      63
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
    term
    Eye pain
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      46
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      72
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      72
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      72
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      63
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      63
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      63
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      46
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      72
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      72
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      72
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      63
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      63
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      63
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
    term
    Lymphadenopathy
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      46
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      72
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      72
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      72
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      63
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      63
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      63
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      46
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      72
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      72
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      72
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      63
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      63
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      63
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
    term
    Pancytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      46
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      72
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      72
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      72
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      63
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      63
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      63
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
    term
    Cardiac failure congestive
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      46
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      72
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      72
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      72
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      63
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      63
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      63
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
    term
    Pericarditis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Congenital, familial and genetic disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      46
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      72
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      72
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      72
    9. group Id
      EG008
      num Affected
      3
      num At Risk
      63
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      63
    11. group Id
      EG010
      num Affected
      2
      num At Risk
      63
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
    term
    Familial mediterranean fever
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Congenital, familial and genetic disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      46
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      72
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      72
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      72
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      63
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      63
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      63
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
    term
    Hyper IgD syndrome
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Congenital, familial and genetic disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      46
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      72
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      72
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      72
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      63
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      63
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      63
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
    term
    Tumour necrosis factor receptor-associated periodic syndrome
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      46
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      72
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      72
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      72
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      63
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      63
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      63
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
    term
    Thyroiditis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      46
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      72
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      72
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      72
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      63
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      63
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      63
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
    term
    Abdominal pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      46
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      46
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      72
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      72
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      72
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      63
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      63
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      63
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      61
    term
    Ascites
time Frame
up to week 112

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

Preserved source evidence · Not medical advice