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NCT02034110 · ADVERSE EVENTS

Adverse events

Efficacy and Safety of the Combination Therapy of Dabrafenib and Trametinib in Subjects With BRAF V600E- Mutated Rare Cancers · Source last updated 2023-08-21

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

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

Collection time frame
Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Other-event reporting threshold
5%

Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Anaplastic Thyroid Cancer (ATC) (On-Treatment)

All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.

20 / 3636 / 366 / 36
Biliary Tract Cancer (BTC) (On-Treatment)

All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.

17 / 4343 / 436 / 43
Gastrointestinal Stromal Tumor (GIST) (On-Treatment)

All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.

1 / 11 / 10 / 1
Low Grade (WHO G1/G2) Glioma (LGG) (On-Treatment)

All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.

3 / 1312 / 131 / 13
High Grade (WHO G3/G4) Glioma (HGG) (On-Treatment)

All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.

16 / 4542 / 452 / 45
Adenocarcinoma of the Small Intestine (ASI) (On-Treatment)

All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.

0 / 33 / 30 / 3
Hairy Cell Leukemia (HCL) (On-Treatment)

All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.

32 / 5555 / 554 / 55
Multiple Myeloma (MM) (On-Treatment)

All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.

4 / 109 / 101 / 10
Anaplastic Thyroid Cancer (ATC) (Post-treatment Survival Follow-up)

Deaths collected in the post- treatment survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period.

0 / 00 / 018 / 30
Biliary Tract Cancer (BTC) (Post-treatment Survival Follow-up)

Deaths collected in the post- treatment survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period.

0 / 00 / 028 / 37
Gastrointestinal Stromal Tumor (GIST) (Post-treatment Survival Follow-up)

Deaths collected in the post- treatment survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period.

0 / 00 / 01 / 1
Low Grade (WHO G1/G2) Glioma (LGG) (Post-treatment Survival Follow-up)

Deaths collected in the post- treatment survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period.

0 / 00 / 03 / 12
High Grade (WHO G3/G4) Glioma (HGG) (Post-treatment Survival Follow-up)

Deaths collected in the post- treatment survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period.

0 / 00 / 026 / 43
Adenocarcinoma of the Small Intestine (ASI) (Post-treatment Survival Follow-up)

Deaths collected in the post- treatment survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period.

0 / 00 / 03 / 3
Hairy Cell Leukemia (HCL) (Post-treatment Survival Follow-up)

Deaths collected in the post- treatment survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period.

0 / 00 / 04 / 51
Multiple Myeloma (MM) (Post-treatment Survival Follow-up)

Deaths collected in the post- treatment survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period.

0 / 00 / 08 / 9

Group identifiers: EG000: Anaplastic Thyroid Cancer (ATC) (On-Treatment) · EG001: Biliary Tract Cancer (BTC) (On-Treatment) · EG002: Gastrointestinal Stromal Tumor (GIST) (On-Treatment) · EG003: Low Grade (WHO G1/G2) Glioma (LGG) (On-Treatment) · EG004: High Grade (WHO G3/G4) Glioma (HGG) (On-Treatment) · EG005: Adenocarcinoma of the Small Intestine (ASI) (On-Treatment) · EG006: Hairy Cell Leukemia (HCL) (On-Treatment) · EG007: Multiple Myeloma (MM) (On-Treatment) · EG008: Anaplastic Thyroid Cancer (ATC) (Post-treatment Survival Follow-up) · EG009: Biliary Tract Cancer (BTC) (Post-treatment Survival Follow-up) · EG010: Gastrointestinal Stromal Tumor (GIST) (Post-treatment Survival Follow-up) · EG011: Low Grade (WHO G1/G2) Glioma (LGG) (Post-treatment Survival Follow-up) · EG012: High Grade (WHO G3/G4) Glioma (HGG) (Post-treatment Survival Follow-up) · EG013: Adenocarcinoma of the Small Intestine (ASI) (Post-treatment Survival Follow-up) · EG014: Hairy Cell Leukemia (HCL) (Post-treatment Survival Follow-up) · EG015: Multiple Myeloma (MM) (Post-treatment Survival 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 (24.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      43
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      45
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      55
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    9. group Id
      EG008
      num At Risk
      0
    10. group Id
      EG009
      num At Risk
      0
    11. group Id
      EG010
      num At Risk
      0
    12. group Id
      EG011
      num At Risk
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      43
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      45
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      55
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    9. group Id
      EG008
      num At Risk
      0
    10. group Id
      EG009
      num At Risk
      0
    11. group Id
      EG010
      num At Risk
      0
    12. group Id
      EG011
      num At Risk
      0
    term
    Autoimmune haemolytic anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      43
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      45
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      55
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    9. group Id
      EG008
      num At Risk
      0
    10. group Id
      EG009
      num At Risk
      0
    11. group Id
      EG010
      num At Risk
      0
    12. group Id
      EG011
      num At Risk
      0
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      43
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      45
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      55
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    9. group Id
      EG008
      num At Risk
      0
    10. group Id
      EG009
      num At Risk
      0
    11. group Id
      EG010
      num At Risk
      0
    12. group Id
      EG011
      num At Risk
      0
    term
    Haemolytic uraemic syndrome
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      43
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      45
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      55
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    9. group Id
      EG008
      num At Risk
      0
    10. group Id
      EG009
      num At Risk
      0
    11. group Id
      EG010
      num At Risk
      0
    12. group Id
      EG011
      num At Risk
      0
    term
    Leukopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      43
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      45
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      55
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    9. group Id
      EG008
      num At Risk
      0
    10. group Id
      EG009
      num At Risk
      0
    11. group Id
      EG010
      num At Risk
      0
    12. group Id
      EG011
      num At Risk
      0
    term
    Neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      43
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      45
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      55
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    9. group Id
      EG008
      num At Risk
      0
    10. group Id
      EG009
      num At Risk
      0
    11. group Id
      EG010
      num At Risk
      0
    12. group Id
      EG011
      num At Risk
      0
    term
    Atrial fibrillation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      43
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      45
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      55
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    9. group Id
      EG008
      num At Risk
      0
    10. group Id
      EG009
      num At Risk
      0
    11. group Id
      EG010
      num At Risk
      0
    12. group Id
      EG011
      num At Risk
      0
    term
    Atrioventricular block
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      43
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      45
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      55
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    9. group Id
      EG008
      num At Risk
      0
    10. group Id
      EG009
      num At Risk
      0
    11. group Id
      EG010
      num At Risk
      0
    12. group Id
      EG011
      num At Risk
      0
    term
    Cardiac ventricular thrombosis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      43
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      45
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      55
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    9. group Id
      EG008
      num At Risk
      0
    10. group Id
      EG009
      num At Risk
      0
    11. group Id
      EG010
      num At Risk
      0
    12. group Id
      EG011
      num At Risk
      0
    term
    Conduction disorder
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      43
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      45
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      55
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    9. group Id
      EG008
      num At Risk
      0
    10. group Id
      EG009
      num At Risk
      0
    11. group Id
      EG010
      num At Risk
      0
    12. group Id
      EG011
      num At Risk
      0
    term
    Myocardial infarction
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      43
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      45
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      55
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    9. group Id
      EG008
      num At Risk
      0
    10. group Id
      EG009
      num At Risk
      0
    11. group Id
      EG010
      num At Risk
      0
    12. group Id
      EG011
      num At Risk
      0
    term
    Myocardial ischaemia

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 (24.1)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      43
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      9
      num At Risk
      45
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      10
      num At Risk
      55
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      10
    9. group Id
      EG008
      num At Risk
      0
    10. group Id
      EG009
      num At Risk
      0
    11. group Id
      EG010
      num At Risk
      0
    12. group Id
      EG011
      num At Risk
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      43
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      45
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      55
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    9. group Id
      EG008
      num At Risk
      0
    10. group Id
      EG009
      num At Risk
      0
    11. group Id
      EG010
      num At Risk
      0
    12. group Id
      EG011
      num At Risk
      0
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      43
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      45
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      55
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    9. group Id
      EG008
      num At Risk
      0
    10. group Id
      EG009
      num At Risk
      0
    11. group Id
      EG010
      num At Risk
      0
    12. group Id
      EG011
      num At Risk
      0
    term
    Lymphopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      43
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      45
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      55
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      10
    9. group Id
      EG008
      num At Risk
      0
    10. group Id
      EG009
      num At Risk
      0
    11. group Id
      EG010
      num At Risk
      0
    12. group Id
      EG011
      num At Risk
      0
    term
    Microcytic anaemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      43
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      7
      num At Risk
      45
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      6
      num At Risk
      55
    8. group Id
      EG007
      num Affected
      4
      num At Risk
      10
    9. group Id
      EG008
      num At Risk
      0
    10. group Id
      EG009
      num At Risk
      0
    11. group Id
      EG010
      num At Risk
      0
    12. group Id
      EG011
      num At Risk
      0
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      43
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      45
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      55
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      10
    9. group Id
      EG008
      num At Risk
      0
    10. group Id
      EG009
      num At Risk
      0
    11. group Id
      EG010
      num At Risk
      0
    12. group Id
      EG011
      num At Risk
      0
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      43
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      45
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      7
      num At Risk
      55
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    9. group Id
      EG008
      num At Risk
      0
    10. group Id
      EG009
      num At Risk
      0
    11. group Id
      EG010
      num At Risk
      0
    12. group Id
      EG011
      num At Risk
      0
    term
    Atrial fibrillation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      43
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      45
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      4
      num At Risk
      55
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    9. group Id
      EG008
      num At Risk
      0
    10. group Id
      EG009
      num At Risk
      0
    11. group Id
      EG010
      num At Risk
      0
    12. group Id
      EG011
      num At Risk
      0
    term
    Atrioventricular block first degree
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      43
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      45
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      55
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    9. group Id
      EG008
      num At Risk
      0
    10. group Id
      EG009
      num At Risk
      0
    11. group Id
      EG010
      num At Risk
      0
    12. group Id
      EG011
      num At Risk
      0
    term
    Bradycardia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      43
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      45
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      13
      num At Risk
      55
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    9. group Id
      EG008
      num At Risk
      0
    10. group Id
      EG009
      num At Risk
      0
    11. group Id
      EG010
      num At Risk
      0
    12. group Id
      EG011
      num At Risk
      0
    term
    Sinus bradycardia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      43
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      45
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      55
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    9. group Id
      EG008
      num At Risk
      0
    10. group Id
      EG009
      num At Risk
      0
    11. group Id
      EG010
      num At Risk
      0
    12. group Id
      EG011
      num At Risk
      0
    term
    Tachycardia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      43
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      45
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      7
      num At Risk
      55
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    9. group Id
      EG008
      num At Risk
      0
    10. group Id
      EG009
      num At Risk
      0
    11. group Id
      EG010
      num At Risk
      0
    12. group Id
      EG011
      num At Risk
      0
    term
    Ear pain
Complete source fields
description
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
event Groups
  1. deaths Num Affected
    6
    deaths Num At Risk
    36
    description
    All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
    id
    EG000
    other Num Affected
    36
    other Num At Risk
    36
    serious Num Affected
    20
    serious Num At Risk
    36
    title
    Anaplastic Thyroid Cancer (ATC) (On-Treatment)
  2. deaths Num Affected
    6
    deaths Num At Risk
    43
    description
    All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
    id
    EG001
    other Num Affected
    43
    other Num At Risk
    43
    serious Num Affected
    17
    serious Num At Risk
    43
    title
    Biliary Tract Cancer (BTC) (On-Treatment)
  3. deaths Num Affected
    0
    deaths Num At Risk
    1
    description
    All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
    id
    EG002
    other Num Affected
    1
    other Num At Risk
    1
    serious Num Affected
    1
    serious Num At Risk
    1
    title
    Gastrointestinal Stromal Tumor (GIST) (On-Treatment)
  4. deaths Num Affected
    1
    deaths Num At Risk
    13
    description
    All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
    id
    EG003
    other Num Affected
    12
    other Num At Risk
    13
    serious Num Affected
    3
    serious Num At Risk
    13
    title
    Low Grade (WHO G1/G2) Glioma (LGG) (On-Treatment)
  5. deaths Num Affected
    2
    deaths Num At Risk
    45
    description
    All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
    id
    EG004
    other Num Affected
    42
    other Num At Risk
    45
    serious Num Affected
    16
    serious Num At Risk
    45
    title
    High Grade (WHO G3/G4) Glioma (HGG) (On-Treatment)
  6. deaths Num Affected
    0
    deaths Num At Risk
    3
    description
    All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
    id
    EG005
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    0
    serious Num At Risk
    3
    title
    Adenocarcinoma of the Small Intestine (ASI) (On-Treatment)
  7. deaths Num Affected
    4
    deaths Num At Risk
    55
    description
    All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
    id
    EG006
    other Num Affected
    55
    other Num At Risk
    55
    serious Num Affected
    32
    serious Num At Risk
    55
    title
    Hairy Cell Leukemia (HCL) (On-Treatment)
  8. deaths Num Affected
    1
    deaths Num At Risk
    10
    description
    All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
    id
    EG007
    other Num Affected
    9
    other Num At Risk
    10
    serious Num Affected
    4
    serious Num At Risk
    10
    title
    Multiple Myeloma (MM) (On-Treatment)
  9. deaths Num Affected
    18
    deaths Num At Risk
    30
    description
    Deaths collected in the post- treatment survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period.
    id
    EG008
    other Num Affected
    0
    other Num At Risk
    0
    serious Num Affected
    0
    serious Num At Risk
    0
    title
    Anaplastic Thyroid Cancer (ATC) (Post-treatment Survival Follow-up)
  10. deaths Num Affected
    28
    deaths Num At Risk
    37
    description
    Deaths collected in the post- treatment survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period.
    id
    EG009
    other Num Affected
    0
    other Num At Risk
    0
    serious Num Affected
    0
    serious Num At Risk
    0
    title
    Biliary Tract Cancer (BTC) (Post-treatment Survival Follow-up)
  11. deaths Num Affected
    1
    deaths Num At Risk
    1
    description
    Deaths collected in the post- treatment survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period.
    id
    EG010
    other Num Affected
    0
    other Num At Risk
    0
    serious Num Affected
    0
    serious Num At Risk
    0
    title
    Gastrointestinal Stromal Tumor (GIST) (Post-treatment Survival Follow-up)
  12. deaths Num Affected
    3
    deaths Num At Risk
    12
    description
    Deaths collected in the post- treatment survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period.
    id
    EG011
    other Num Affected
    0
    other Num At Risk
    0
    serious Num Affected
    0
    serious Num At Risk
    0
    title
    Low Grade (WHO G1/G2) Glioma (LGG) (Post-treatment Survival Follow-up)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      43
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      9
      num At Risk
      45
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      10
      num At Risk
      55
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      10
    9. group Id
      EG008
      num At Risk
      0
    10. group Id
      EG009
      num At Risk
      0
    11. group Id
      EG010
      num At Risk
      0
    12. group Id
      EG011
      num At Risk
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      43
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      45
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      55
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    9. group Id
      EG008
      num At Risk
      0
    10. group Id
      EG009
      num At Risk
      0
    11. group Id
      EG010
      num At Risk
      0
    12. group Id
      EG011
      num At Risk
      0
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      43
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      45
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      55
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    9. group Id
      EG008
      num At Risk
      0
    10. group Id
      EG009
      num At Risk
      0
    11. group Id
      EG010
      num At Risk
      0
    12. group Id
      EG011
      num At Risk
      0
    term
    Lymphopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      43
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      45
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      55
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      10
    9. group Id
      EG008
      num At Risk
      0
    10. group Id
      EG009
      num At Risk
      0
    11. group Id
      EG010
      num At Risk
      0
    12. group Id
      EG011
      num At Risk
      0
    term
    Microcytic anaemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      43
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      7
      num At Risk
      45
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      6
      num At Risk
      55
    8. group Id
      EG007
      num Affected
      4
      num At Risk
      10
    9. group Id
      EG008
      num At Risk
      0
    10. group Id
      EG009
      num At Risk
      0
    11. group Id
      EG010
      num At Risk
      0
    12. group Id
      EG011
      num At Risk
      0
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      43
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      45
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      55
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      10
    9. group Id
      EG008
      num At Risk
      0
    10. group Id
      EG009
      num At Risk
      0
    11. group Id
      EG010
      num At Risk
      0
    12. group Id
      EG011
      num At Risk
      0
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      43
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      45
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      7
      num At Risk
      55
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    9. group Id
      EG008
      num At Risk
      0
    10. group Id
      EG009
      num At Risk
      0
    11. group Id
      EG010
      num At Risk
      0
    12. group Id
      EG011
      num At Risk
      0
    term
    Atrial fibrillation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      43
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      45
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      4
      num At Risk
      55
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    9. group Id
      EG008
      num At Risk
      0
    10. group Id
      EG009
      num At Risk
      0
    11. group Id
      EG010
      num At Risk
      0
    12. group Id
      EG011
      num At Risk
      0
    term
    Atrioventricular block first degree
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      43
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      45
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      55
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    9. group Id
      EG008
      num At Risk
      0
    10. group Id
      EG009
      num At Risk
      0
    11. group Id
      EG010
      num At Risk
      0
    12. group Id
      EG011
      num At Risk
      0
    term
    Bradycardia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      43
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      45
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      13
      num At Risk
      55
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    9. group Id
      EG008
      num At Risk
      0
    10. group Id
      EG009
      num At Risk
      0
    11. group Id
      EG010
      num At Risk
      0
    12. group Id
      EG011
      num At Risk
      0
    term
    Sinus bradycardia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      43
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      45
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      55
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    9. group Id
      EG008
      num At Risk
      0
    10. group Id
      EG009
      num At Risk
      0
    11. group Id
      EG010
      num At Risk
      0
    12. group Id
      EG011
      num At Risk
      0
    term
    Tachycardia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      43
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      45
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      7
      num At Risk
      55
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    9. group Id
      EG008
      num At Risk
      0
    10. group Id
      EG009
      num At Risk
      0
    11. group Id
      EG010
      num At Risk
      0
    12. group Id
      EG011
      num At Risk
      0
    term
    Ear pain
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      43
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      45
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      55
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    9. group Id
      EG008
      num At Risk
      0
    10. group Id
      EG009
      num At Risk
      0
    11. group Id
      EG010
      num At Risk
      0
    12. group Id
      EG011
      num At Risk
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      43
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      45
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      55
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    9. group Id
      EG008
      num At Risk
      0
    10. group Id
      EG009
      num At Risk
      0
    11. group Id
      EG010
      num At Risk
      0
    12. group Id
      EG011
      num At Risk
      0
    term
    Autoimmune haemolytic anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      43
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      45
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      55
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    9. group Id
      EG008
      num At Risk
      0
    10. group Id
      EG009
      num At Risk
      0
    11. group Id
      EG010
      num At Risk
      0
    12. group Id
      EG011
      num At Risk
      0
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      43
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      45
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      55
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    9. group Id
      EG008
      num At Risk
      0
    10. group Id
      EG009
      num At Risk
      0
    11. group Id
      EG010
      num At Risk
      0
    12. group Id
      EG011
      num At Risk
      0
    term
    Haemolytic uraemic syndrome
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      43
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      45
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      55
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    9. group Id
      EG008
      num At Risk
      0
    10. group Id
      EG009
      num At Risk
      0
    11. group Id
      EG010
      num At Risk
      0
    12. group Id
      EG011
      num At Risk
      0
    term
    Leukopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      43
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      45
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      55
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    9. group Id
      EG008
      num At Risk
      0
    10. group Id
      EG009
      num At Risk
      0
    11. group Id
      EG010
      num At Risk
      0
    12. group Id
      EG011
      num At Risk
      0
    term
    Neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      43
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      45
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      55
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    9. group Id
      EG008
      num At Risk
      0
    10. group Id
      EG009
      num At Risk
      0
    11. group Id
      EG010
      num At Risk
      0
    12. group Id
      EG011
      num At Risk
      0
    term
    Atrial fibrillation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      43
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      45
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      55
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    9. group Id
      EG008
      num At Risk
      0
    10. group Id
      EG009
      num At Risk
      0
    11. group Id
      EG010
      num At Risk
      0
    12. group Id
      EG011
      num At Risk
      0
    term
    Atrioventricular block
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      43
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      45
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      55
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    9. group Id
      EG008
      num At Risk
      0
    10. group Id
      EG009
      num At Risk
      0
    11. group Id
      EG010
      num At Risk
      0
    12. group Id
      EG011
      num At Risk
      0
    term
    Cardiac ventricular thrombosis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      43
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      45
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      55
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    9. group Id
      EG008
      num At Risk
      0
    10. group Id
      EG009
      num At Risk
      0
    11. group Id
      EG010
      num At Risk
      0
    12. group Id
      EG011
      num At Risk
      0
    term
    Conduction disorder
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      43
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      45
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      55
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    9. group Id
      EG008
      num At Risk
      0
    10. group Id
      EG009
      num At Risk
      0
    11. group Id
      EG010
      num At Risk
      0
    12. group Id
      EG011
      num At Risk
      0
    term
    Myocardial infarction
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      43
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      45
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      55
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    9. group Id
      EG008
      num At Risk
      0
    10. group Id
      EG009
      num At Risk
      0
    11. group Id
      EG010
      num At Risk
      0
    12. group Id
      EG011
      num At Risk
      0
    term
    Myocardial ischaemia
time Frame
Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.

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Preserved source evidence · Independent clinical review pending · Not medical advice