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NCT01390818 · ADVERSE EVENTS

Adverse events

Trial of MEK Inhibitor and PI3K/mTOR Inhibitor in Subjects With Locally Advanced or Metastatic Solid Tumors · Source last updated 2017-03-07

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
Baseline up to 30 Days after last dose; assessed up to 4 years
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
MSC1936369B (Pimasertib) 15mg and SAR245409 30mg Once Daily

MSC1936369B (Pimasertib) capsule administered at a single dose of 15 milligram (mg) on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 30 mg on day 1 of each cycle (21 days) (DE cohort).

1 / 33 / 3Not reported / Not reported
MSC1936369B (Pimasertib) 30mg and SAR245409 30mg Once Daily

MSC1936369B (Pimasertib) capsule administered at a single dose of 30 mg on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 30 mg on day 1 of each cycle (21 days) (DE cohort).

0 / 33 / 3Not reported / Not reported
MSC1936369B (Pimasertib) 15mg and SAR245409 50mg Once Daily

MSC1936369B (Pimasertib) capsule administered at a single dose of 15 mg on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 50 mg on day 1 of each cycle (21 days) (DE cohort).

2 / 33 / 3Not reported / Not reported
MSC1936369B (Pimasertib) 30mg and SAR245409 50mg Once Daily

MSC1936369B (Pimasertib) capsule administered at a single dose of 30 mg on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 50 mg on day 1 of each cycle (21 days) (DE cohort).

1 / 44 / 4Not reported / Not reported
MSC1936369B (Pimasertib) 60mg and SAR245409 50mg Once Daily

MSC1936369B (Pimasertib) capsule administered at a single dose of 60 mg on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 50 mg on day 1 of each cycle (21 days) (DE cohort).

1 / 44 / 4Not reported / Not reported
MSC1936369B (Pimasertib) 30mg and SAR245409 70mg Once Daily

MSC1936369B (Pimasertib) capsule administered at a single dose of 30 mg on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 70 mg on day 1 of each cycle (21 days) (DE cohort).

1 / 33 / 3Not reported / Not reported
MSC1936369B (Pimasertib) 60mg and SAR245409 70mg Once Daily

MSC1936369B (Pimasertib) capsule administered at a single dose of 60 mg on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 70 mg on day 1 of each cycle (21 days) (DE cohort).

14 / 1919 / 19Not reported / Not reported
MSC1936369B (Pimasertib) 90mg and SAR245409 70mg Once Daily

MSC1936369B (Pimasertib) capsule administered at a single dose of 90 mg on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 70 mg on day 1 of each cycle (21 days) (DE cohort).

10 / 1414 / 14Not reported / Not reported
MSC1936369B (Pimasertib) 60mg and SAR245409 90mg Once Daily

MSC1936369B (Pimasertib) capsule administered at a single dose of 60 mg on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 90 mg on day 1 of each cycle (21 days) (DE cohort).

1 / 33 / 3Not reported / Not reported
MSC1936369B (Pimasertib) 60mg and SAR245409 30mg Twice Daily

MSC1936369B (Pimasertib) capsule administered twice at a dose of 60 mg on day 1 and 15 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 30 mg on day 1 and 15 of each cycle (21 days) (DE cohort).

2 / 33 / 3Not reported / Not reported
MSC1936369B (Pimasertib) 45mg and SAR245409 50mg Twice Daily

MSC1936369B (Pimasertib) capsule administered twice at a dose of 45 mg on day 1 and 15 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 50 mg on day 1 and 15 of each cycle (21 days) (DE cohort).

3 / 44 / 4Not reported / Not reported
TNBC: Pimasertib 60mg and SAR245409 70mg Once Daily

Participants with relapsed or refractory metastatic triple negative breast cancer (TNBC) defined as estrogen, progesterone, and human epidermal growth factor receptor 2 (HER2) negative carcinoma of the breast with no approved therapies received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the participant (DSE Cohort).

16 / 2626 / 26Not reported / Not reported
NSCLC: Pimasertib 60mg and SAR245409 70mg Once Daily

Participants with a histologically confirmed diagnosis of relapsed or refractory metastatic non-small cell lung cancer (NSCLC) in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the participant (DSE Cohort).

13 / 2424 / 24Not reported / Not reported
CRC: Pimasertib 60mg and SAR245409 70mg Once Daily

Participants with relapsed or refractory metastatic colorectal carcinoma/cancer (CRC) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the participant (DSE Cohort).

10 / 1818 / 18Not reported / Not reported
MEL: Pimasertib 60mg and SAR245409 70mg Once Daily

Participants with relapsed or refractory metastatic melanoma (MEL) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the participant (DSE Cohort).

8 / 1515 / 15Not reported / Not reported

Group identifiers: EG000: MSC1936369B (Pimasertib) 15mg and SAR245409 30mg Once Daily · EG001: MSC1936369B (Pimasertib) 30mg and SAR245409 30mg Once Daily · EG002: MSC1936369B (Pimasertib) 15mg and SAR245409 50mg Once Daily · EG003: MSC1936369B (Pimasertib) 30mg and SAR245409 50mg Once Daily · EG004: MSC1936369B (Pimasertib) 60mg and SAR245409 50mg Once Daily · EG005: MSC1936369B (Pimasertib) 30mg and SAR245409 70mg Once Daily · EG006: MSC1936369B (Pimasertib) 60mg and SAR245409 70mg Once Daily · EG007: MSC1936369B (Pimasertib) 90mg and SAR245409 70mg Once Daily · EG008: MSC1936369B (Pimasertib) 60mg and SAR245409 90mg Once Daily · EG009: MSC1936369B (Pimasertib) 60mg and SAR245409 30mg Twice Daily · EG010: MSC1936369B (Pimasertib) 45mg and SAR245409 50mg Twice Daily · EG011: TNBC: Pimasertib 60mg and SAR245409 70mg Once Daily · EG012: NSCLC: Pimasertib 60mg and SAR245409 70mg Once Daily · EG013: CRC: Pimasertib 60mg and SAR245409 70mg Once Daily · EG014: MEL: Pimasertib 60mg and SAR245409 70mg Once Daily

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      14
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      26
    term
    FEBRILE NEUTROPENIA
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      14
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      26
    term
    LEUKOPENIA
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      14
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      26
    term
    NAUSEA
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      14
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      26
    term
    VOMITING
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      14
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      26
    term
    ABDOMINAL PAIN LOWER
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      14
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      26
    term
    ABDOMINAL PAIN UPPER
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      14
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      26
    term
    ASCITES
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      14
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      2
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      26
    term
    DIARRHOEA
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      14
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      26
    term
    DYSPHAGIA
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      14
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      26
    term
    SMALL INTESTINAL OBSTRUCTION
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      4
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      14
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      2
      num At Risk
      26
    term
    PYREXIA
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      4
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      14
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      2
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      26
    term
    DISEASE PROGRESSION

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      7
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      14
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      4
      num At Risk
      26
    term
    ANAEMIA
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      14
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      5
      num At Risk
      26
    term
    THROMBOCYTOPENIA
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      14
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      26
    term
    LEUKOCYTOSIS
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      14
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      26
    term
    LEUKOPENIA
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      14
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      3
      num At Risk
      26
    term
    IRON DEFICIENCY ANAEMIA
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      14
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      26
    term
    ANAEMIA MACROCYTIC
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      14
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      2
      num At Risk
      26
    term
    NEUTROPENIA
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      14
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      26
    term
    LEUKOCYTOSIS
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      14
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      26
    term
    SINUS TACHYCARDIA
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      14
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      26
    term
    PALPITATIONS
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      14
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      26
    term
    ATRIAL FLUTTER
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      14
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      26
    term
    PERICARDIAL EFFUSION
Complete source fields
event Groups
  1. description
    MSC1936369B (Pimasertib) capsule administered at a single dose of 15 milligram (mg) on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 30 mg on day 1 of each cycle (21 days) (DE cohort).
    id
    EG000
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    1
    serious Num At Risk
    3
    title
    MSC1936369B (Pimasertib) 15mg and SAR245409 30mg Once Daily
  2. description
    MSC1936369B (Pimasertib) capsule administered at a single dose of 30 mg on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 30 mg on day 1 of each cycle (21 days) (DE cohort).
    id
    EG001
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    0
    serious Num At Risk
    3
    title
    MSC1936369B (Pimasertib) 30mg and SAR245409 30mg Once Daily
  3. description
    MSC1936369B (Pimasertib) capsule administered at a single dose of 15 mg on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 50 mg on day 1 of each cycle (21 days) (DE cohort).
    id
    EG002
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    2
    serious Num At Risk
    3
    title
    MSC1936369B (Pimasertib) 15mg and SAR245409 50mg Once Daily
  4. description
    MSC1936369B (Pimasertib) capsule administered at a single dose of 30 mg on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 50 mg on day 1 of each cycle (21 days) (DE cohort).
    id
    EG003
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    1
    serious Num At Risk
    4
    title
    MSC1936369B (Pimasertib) 30mg and SAR245409 50mg Once Daily
  5. description
    MSC1936369B (Pimasertib) capsule administered at a single dose of 60 mg on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 50 mg on day 1 of each cycle (21 days) (DE cohort).
    id
    EG004
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    1
    serious Num At Risk
    4
    title
    MSC1936369B (Pimasertib) 60mg and SAR245409 50mg Once Daily
  6. description
    MSC1936369B (Pimasertib) capsule administered at a single dose of 30 mg on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 70 mg on day 1 of each cycle (21 days) (DE cohort).
    id
    EG005
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    1
    serious Num At Risk
    3
    title
    MSC1936369B (Pimasertib) 30mg and SAR245409 70mg Once Daily
  7. description
    MSC1936369B (Pimasertib) capsule administered at a single dose of 60 mg on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 70 mg on day 1 of each cycle (21 days) (DE cohort).
    id
    EG006
    other Num Affected
    19
    other Num At Risk
    19
    serious Num Affected
    14
    serious Num At Risk
    19
    title
    MSC1936369B (Pimasertib) 60mg and SAR245409 70mg Once Daily
  8. description
    MSC1936369B (Pimasertib) capsule administered at a single dose of 90 mg on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 70 mg on day 1 of each cycle (21 days) (DE cohort).
    id
    EG007
    other Num Affected
    14
    other Num At Risk
    14
    serious Num Affected
    10
    serious Num At Risk
    14
    title
    MSC1936369B (Pimasertib) 90mg and SAR245409 70mg Once Daily
  9. description
    MSC1936369B (Pimasertib) capsule administered at a single dose of 60 mg on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 90 mg on day 1 of each cycle (21 days) (DE cohort).
    id
    EG008
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    1
    serious Num At Risk
    3
    title
    MSC1936369B (Pimasertib) 60mg and SAR245409 90mg Once Daily
  10. description
    MSC1936369B (Pimasertib) capsule administered twice at a dose of 60 mg on day 1 and 15 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 30 mg on day 1 and 15 of each cycle (21 days) (DE cohort).
    id
    EG009
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    2
    serious Num At Risk
    3
    title
    MSC1936369B (Pimasertib) 60mg and SAR245409 30mg Twice Daily
  11. description
    MSC1936369B (Pimasertib) capsule administered twice at a dose of 45 mg on day 1 and 15 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 50 mg on day 1 and 15 of each cycle (21 days) (DE cohort).
    id
    EG010
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    3
    serious Num At Risk
    4
    title
    MSC1936369B (Pimasertib) 45mg and SAR245409 50mg Twice Daily
  12. description
    Participants with relapsed or refractory metastatic triple negative breast cancer (TNBC) defined as estrogen, progesterone, and human epidermal growth factor receptor 2 (HER2) negative carcinoma of the breast with no approved therapies received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the participant (DSE Cohort).
    id
    EG011
    other Num Affected
    26
    other Num At Risk
    26
    serious Num Affected
    16
    serious Num At Risk
    26
    title
    TNBC: Pimasertib 60mg and SAR245409 70mg Once Daily
frequency Threshold
0
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      7
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      14
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      4
      num At Risk
      26
    term
    ANAEMIA
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      14
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      5
      num At Risk
      26
    term
    THROMBOCYTOPENIA
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      14
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      26
    term
    LEUKOCYTOSIS
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      14
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      26
    term
    LEUKOPENIA
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      14
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      3
      num At Risk
      26
    term
    IRON DEFICIENCY ANAEMIA
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      14
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      26
    term
    ANAEMIA MACROCYTIC
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      14
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      2
      num At Risk
      26
    term
    NEUTROPENIA
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      14
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      26
    term
    LEUKOCYTOSIS
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      14
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      26
    term
    SINUS TACHYCARDIA
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      14
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      26
    term
    PALPITATIONS
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      14
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      26
    term
    ATRIAL FLUTTER
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      14
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      26
    term
    PERICARDIAL EFFUSION
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      14
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      26
    term
    FEBRILE NEUTROPENIA
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      14
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      26
    term
    LEUKOPENIA
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      14
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      26
    term
    NAUSEA
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      14
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      26
    term
    VOMITING
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      14
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      26
    term
    ABDOMINAL PAIN LOWER
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      14
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      26
    term
    ABDOMINAL PAIN UPPER
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      14
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      26
    term
    ASCITES
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      14
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      2
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      26
    term
    DIARRHOEA
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      14
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      26
    term
    DYSPHAGIA
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      14
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      26
    term
    SMALL INTESTINAL OBSTRUCTION
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      4
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      14
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      2
      num At Risk
      26
    term
    PYREXIA
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      4
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      14
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      2
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      26
    term
    DISEASE PROGRESSION
time Frame
Baseline up to 30 Days after last dose; assessed up to 4 years

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Preserved source evidence · Not medical advice