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NCT01928394 · ADVERSE EVENTS

Adverse events

A Study of Nivolumab by Itself or Nivolumab Combined With Ipilimumab in Patients With Advanced or Metastatic Solid Tumors · Source last updated 2024-12-27

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
Includes events reported between first dose and 30 days (AEs) or 100 days (SAEs) after last dose of study therapy
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
TNBC Arm N

Triple Negative Breast Cancer (TNBC) Nivolumab monotherapy (3 mg/kg) Q2W

9 / 1818 / 1817 / 18
TNBC Arm N-I Dose Level 1

Triple Negative Breast Cancer (TNBC) Nivolumab (1 mg/kg) + ipilimumab (1 mg/kg) Q3W for 4 doses, then nivolumab (3 mg/kg) Q2W

2 / 33 / 33 / 3
TNBC Arm N-I Dose Level 2

Triple Negative Breast Cancer (TNBC) Nivolumab (1 mg/kg) + ipilimumab (3 mg/kg) Q3W for 4 doses, then nivolumab (3 mg/kg) Q2W

11 / 1817 / 1818 / 18
GC Arm N

Gastric Cancer (GC) Nivolumab 3 mg/kg Q2W

32 / 5958 / 5953 / 59
GC Arm N-I Dose Level 1

Gastric Cancer(GC) Nivolumab (1 mg/kg) + ipilimumab (1 mg/kg) Q3W for 4 doses, then nivolumab (3 mg/kg) Q2W

1 / 33 / 33 / 3
GC Arm N-I Dose Level 2

Gastric Cancer (GC) nivolumab (1 mg/kg) + ipilimumab (3 mg/kg) Q3W for 4 doses; then nivolumab 3 mg/kg Q2W

37 / 4947 / 4942 / 49
GC Arm N-I Dose Level 2b

Gastric Cancer (GC) Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W for 4 doses, then Nivolumab (3 mg/kg) Q2W

34 / 5249 / 5250 / 52
PC Arm N

Pancreatic cancer (PC) participants: Nivolumab 3 mg/kg Q2W

10 / 1818 / 1818 / 18
PC Arm N-I Dose Level 1

Pancreatic cancer (PC) participants: Nivolumab 1 mg/kg + Ipilimumab 1 mg/kg Q3W for 4 doses, then Nivolumab (3 mg/kg) Q2W

3 / 33 / 33 / 3
PC Arm N-I Dose Level 2

Pancreatic cancer (PC) participants: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q3W for 4 doses, then Nivolumab (3 mg/kg) Q2W

11 / 1817 / 1818 / 18
PC Arm N-I Dose Level 2d

Pancreatic cancer (PC) participants: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q6W for 4 doses + cobimetinib 60 mg po qd 21 days on/7 days off

16 / 3029 / 3024 / 30
SCLC Arm N

Small cell lung cancer (SCLC) pre-expansion and expansion cohort participants: Nivolumab monotherapy (3 mg/kg) Q2W

129 / 245226 / 245212 / 245
SCLC Arm N-I Dose Level 2

Small cell lung cancer (SCLC) pre-expansion and expansion cohort participants: Nivolumab (1 mg/kg) + ipilimumab (3 mg/kg) Q3W for 4 doses, then nivolumab (3 mg/kg) Q2Wi

111 / 157147 / 157136 / 157
SCLC Arm N-I Dose Level 1

Small cell lung cancer (SCLC) participants treated with Nivolumab (1 mg/kg) + ipilimumab (1 mg/kg) Q3W for 4 doses, then nivolumab (3mg/kg) Q2W

2 / 33 / 33 / 3
SCLC Arm N-I Dose Level 2b

Small cell lung cancer (SCLC) treated participants treated with Nivolumab (3 mg/kg) + ipilimumab (1 mg/kg) Q3W for 4 doses, then nivolumab (3 mg/kg) Q2W

32 / 5553 / 5545 / 55
BC Arm N

Bladder cancer (BC) participants: Nivolumab 3 mg/kg Q2W

41 / 7877 / 7860 / 78
BC Arm N-I Dose Level 2

Bladder cancer (BC) participants: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q3W for 4 doses, then Nivolumab (3 mg/kg) Q2W

62 / 9285 / 9254 / 92
BC Arm N-I Dose Level 2b

Bladder cancer (BC) participants: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W for 4 doses, then Nivolumab (3 mg/kg) Q2W

72 / 104100 / 10482 / 104
OC Arm N-I Dose Level 2

Ovarian cancer (OC) participants: Nivolumab (1 mg/kg) + ipilimumab (3 mg/kg) Q3W for 4 doses, then nivolumab (3 mg/kg) Q2W

24 / 4138 / 4133 / 41
OC Arm N-I Dose Level 2b

Ovarian cancer (OC) participants: Nivolumab (3 mg/kg) + ipilimumab (1 mg/kg) Q3W for 4 doses,then nivolumab (3 mg/kg) Q2W

31 / 4340 / 4337 / 43
OC Arm N-I Dose Level 2c

Ovarian cancer (OC) participants: Nivolumab (3 mg/kg) Q2W + ipilimumab (1 mg/kg) Q6W

29 / 4241 / 4234 / 42

Group identifiers: EG000: TNBC Arm N · EG001: TNBC Arm N-I Dose Level 1 · EG002: TNBC Arm N-I Dose Level 2 · EG003: GC Arm N · EG004: GC Arm N-I Dose Level 1 · EG005: GC Arm N-I Dose Level 2 · EG006: GC Arm N-I Dose Level 2b · EG007: PC Arm N · EG008: PC Arm N-I Dose Level 1 · EG009: PC Arm N-I Dose Level 2 · EG010: PC Arm N-I Dose Level 2d · EG011: SCLC Arm N · EG012: SCLC Arm N-I Dose Level 2 · EG013: SCLC Arm N-I Dose Level 1 · EG014: SCLC Arm N-I Dose Level 2b · EG015: BC Arm N · EG016: BC Arm N-I Dose Level 2 · EG017: BC Arm N-I Dose Level 2b · EG018: OC Arm N-I Dose Level 2 · EG019: OC Arm N-I Dose Level 2b · EG020: OC Arm N-I Dose Level 2c

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 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      59
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      49
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      52
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      18
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      30
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      245
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      59
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      49
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      52
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      18
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      30
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      245
    term
    Blood loss anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      59
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      49
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      52
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      18
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      30
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      245
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      59
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      49
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      52
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      18
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      30
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      245
    term
    Leukocytosis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      18
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      59
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      49
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      52
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      18
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      30
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      245
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      59
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      49
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      52
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      18
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      30
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      245
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      59
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      49
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      52
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      18
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      30
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      245
    term
    Acute coronary syndrome
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      59
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      49
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      52
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      18
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      30
    12. group Id
      EG011
      num Affected
      2
      num At Risk
      245
    term
    Acute myocardial infarction
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      59
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      49
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      52
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      18
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      30
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      245
    term
    Angina pectoris
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      59
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      49
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      52
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      18
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      30
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      245
    term
    Arrhythmia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      59
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      49
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      52
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      18
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      30
    12. group Id
      EG011
      num Affected
      4
      num At Risk
      245
    term
    Atrial fibrillation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      59
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      49
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      52
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      18
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      30
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      245
    term
    Atrial tachycardia

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 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      18
    4. group Id
      EG003
      num Affected
      19
      num At Risk
      59
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      12
      num At Risk
      49
    7. group Id
      EG006
      num Affected
      17
      num At Risk
      52
    8. group Id
      EG007
      num Affected
      5
      num At Risk
      18
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      8
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      3
      num At Risk
      30
    12. group Id
      EG011
      num Affected
      37
      num At Risk
      245
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      59
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      49
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      52
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      18
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      30
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      245
    term
    Leukocytosis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      18
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      59
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      49
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      52
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      18
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      30
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      245
    term
    Leukopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      59
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      49
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      52
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      18
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      30
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      245
    term
    Lymphopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      18
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      59
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      49
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      52
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      18
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      30
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      245
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      18
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      59
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      49
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      52
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      18
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      2
      num At Risk
      30
    12. group Id
      EG011
      num Affected
      5
      num At Risk
      245
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      59
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      49
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      52
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      18
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      30
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      245
    term
    Atrial fibrillation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      59
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      49
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      52
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      18
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      30
    12. group Id
      EG011
      num Affected
      2
      num At Risk
      245
    term
    Palpitations
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      59
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      49
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      52
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      18
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      30
    12. group Id
      EG011
      num Affected
      6
      num At Risk
      245
    term
    Sinus tachycardia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      59
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      49
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      52
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      18
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      30
    12. group Id
      EG011
      num Affected
      4
      num At Risk
      245
    term
    Tachycardia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      59
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      49
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      52
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      18
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      30
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      245
    term
    Ear pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      59
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      49
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      52
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      18
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      30
    12. group Id
      EG011
      num Affected
      5
      num At Risk
      245
    term
    Vertigo
Complete source fields
event Groups
  1. deaths Num Affected
    17
    deaths Num At Risk
    18
    description
    Triple Negative Breast Cancer (TNBC) Nivolumab monotherapy (3 mg/kg) Q2W
    id
    EG000
    other Num Affected
    18
    other Num At Risk
    18
    serious Num Affected
    9
    serious Num At Risk
    18
    title
    TNBC Arm N
  2. deaths Num Affected
    3
    deaths Num At Risk
    3
    description
    Triple Negative Breast Cancer (TNBC) Nivolumab (1 mg/kg) + ipilimumab (1 mg/kg) Q3W for 4 doses, then nivolumab (3 mg/kg) Q2W
    id
    EG001
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    2
    serious Num At Risk
    3
    title
    TNBC Arm N-I Dose Level 1
  3. deaths Num Affected
    18
    deaths Num At Risk
    18
    description
    Triple Negative Breast Cancer (TNBC) Nivolumab (1 mg/kg) + ipilimumab (3 mg/kg) Q3W for 4 doses, then nivolumab (3 mg/kg) Q2W
    id
    EG002
    other Num Affected
    17
    other Num At Risk
    18
    serious Num Affected
    11
    serious Num At Risk
    18
    title
    TNBC Arm N-I Dose Level 2
  4. deaths Num Affected
    53
    deaths Num At Risk
    59
    description
    Gastric Cancer (GC) Nivolumab 3 mg/kg Q2W
    id
    EG003
    other Num Affected
    58
    other Num At Risk
    59
    serious Num Affected
    32
    serious Num At Risk
    59
    title
    GC Arm N
  5. deaths Num Affected
    3
    deaths Num At Risk
    3
    description
    Gastric Cancer(GC) Nivolumab (1 mg/kg) + ipilimumab (1 mg/kg) Q3W for 4 doses, then nivolumab (3 mg/kg) Q2W
    id
    EG004
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    1
    serious Num At Risk
    3
    title
    GC Arm N-I Dose Level 1
  6. deaths Num Affected
    42
    deaths Num At Risk
    49
    description
    Gastric Cancer (GC) nivolumab (1 mg/kg) + ipilimumab (3 mg/kg) Q3W for 4 doses; then nivolumab 3 mg/kg Q2W
    id
    EG005
    other Num Affected
    47
    other Num At Risk
    49
    serious Num Affected
    37
    serious Num At Risk
    49
    title
    GC Arm N-I Dose Level 2
  7. deaths Num Affected
    50
    deaths Num At Risk
    52
    description
    Gastric Cancer (GC) Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W for 4 doses, then Nivolumab (3 mg/kg) Q2W
    id
    EG006
    other Num Affected
    49
    other Num At Risk
    52
    serious Num Affected
    34
    serious Num At Risk
    52
    title
    GC Arm N-I Dose Level 2b
  8. deaths Num Affected
    18
    deaths Num At Risk
    18
    description
    Pancreatic cancer (PC) participants: Nivolumab 3 mg/kg Q2W
    id
    EG007
    other Num Affected
    18
    other Num At Risk
    18
    serious Num Affected
    10
    serious Num At Risk
    18
    title
    PC Arm N
  9. deaths Num Affected
    3
    deaths Num At Risk
    3
    description
    Pancreatic cancer (PC) participants: Nivolumab 1 mg/kg + Ipilimumab 1 mg/kg Q3W for 4 doses, then Nivolumab (3 mg/kg) Q2W
    id
    EG008
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    3
    serious Num At Risk
    3
    title
    PC Arm N-I Dose Level 1
  10. deaths Num Affected
    18
    deaths Num At Risk
    18
    description
    Pancreatic cancer (PC) participants: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q3W for 4 doses, then Nivolumab (3 mg/kg) Q2W
    id
    EG009
    other Num Affected
    17
    other Num At Risk
    18
    serious Num Affected
    11
    serious Num At Risk
    18
    title
    PC Arm N-I Dose Level 2
  11. deaths Num Affected
    24
    deaths Num At Risk
    30
    description
    Pancreatic cancer (PC) participants: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q6W for 4 doses + cobimetinib 60 mg po qd 21 days on/7 days off
    id
    EG010
    other Num Affected
    29
    other Num At Risk
    30
    serious Num Affected
    16
    serious Num At Risk
    30
    title
    PC Arm N-I Dose Level 2d
  12. deaths Num Affected
    212
    deaths Num At Risk
    245
    description
    Small cell lung cancer (SCLC) pre-expansion and expansion cohort participants: Nivolumab monotherapy (3 mg/kg) Q2W
    id
    EG011
    other Num Affected
    226
    other Num At Risk
    245
    serious Num Affected
    129
    serious Num At Risk
    245
    title
    SCLC Arm N
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      18
    4. group Id
      EG003
      num Affected
      19
      num At Risk
      59
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      12
      num At Risk
      49
    7. group Id
      EG006
      num Affected
      17
      num At Risk
      52
    8. group Id
      EG007
      num Affected
      5
      num At Risk
      18
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      8
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      3
      num At Risk
      30
    12. group Id
      EG011
      num Affected
      37
      num At Risk
      245
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      59
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      49
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      52
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      18
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      30
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      245
    term
    Leukocytosis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      18
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      59
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      49
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      52
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      18
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      30
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      245
    term
    Leukopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      59
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      49
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      52
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      18
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      30
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      245
    term
    Lymphopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      18
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      59
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      49
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      52
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      18
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      30
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      245
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      18
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      59
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      49
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      52
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      18
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      2
      num At Risk
      30
    12. group Id
      EG011
      num Affected
      5
      num At Risk
      245
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      59
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      49
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      52
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      18
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      30
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      245
    term
    Atrial fibrillation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      59
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      49
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      52
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      18
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      30
    12. group Id
      EG011
      num Affected
      2
      num At Risk
      245
    term
    Palpitations
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      59
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      49
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      52
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      18
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      30
    12. group Id
      EG011
      num Affected
      6
      num At Risk
      245
    term
    Sinus tachycardia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      59
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      49
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      52
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      18
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      30
    12. group Id
      EG011
      num Affected
      4
      num At Risk
      245
    term
    Tachycardia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      59
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      49
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      52
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      18
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      30
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      245
    term
    Ear pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      59
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      49
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      52
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      18
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      30
    12. group Id
      EG011
      num Affected
      5
      num At Risk
      245
    term
    Vertigo
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      59
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      49
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      52
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      18
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      30
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      245
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      59
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      49
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      52
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      18
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      30
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      245
    term
    Blood loss anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      59
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      49
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      52
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      18
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      30
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      245
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      59
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      49
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      52
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      18
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      30
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      245
    term
    Leukocytosis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      18
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      59
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      49
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      52
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      18
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      30
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      245
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      59
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      49
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      52
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      18
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      30
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      245
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      59
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      49
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      52
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      18
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      30
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      245
    term
    Acute coronary syndrome
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      59
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      49
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      52
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      18
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      30
    12. group Id
      EG011
      num Affected
      2
      num At Risk
      245
    term
    Acute myocardial infarction
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      59
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      49
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      52
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      18
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      30
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      245
    term
    Angina pectoris
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      59
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      49
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      52
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      18
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      30
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      245
    term
    Arrhythmia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      59
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      49
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      52
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      18
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      30
    12. group Id
      EG011
      num Affected
      4
      num At Risk
      245
    term
    Atrial fibrillation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      59
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      49
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      52
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      18
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      30
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      245
    term
    Atrial tachycardia
time Frame
Includes events reported between first dose and 30 days (AEs) or 100 days (SAEs) after last dose of study therapy

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Preserved source evidence · Not medical advice