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NCT02460224 · ADVERSE EVENTS

Adverse events

Safety and Efficacy of LAG525 Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies. · Source last updated 2022-02-10

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
From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Other-event reporting threshold
5%

Any sign or symptom that occurs during the study treatment plus 30 days post treatment.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Phase 1: LAG525 1 mg/kg Q2W

Single-agent LAG525 1 mg/kg Q2W (ROW patients)

4 / 1313 / 131 / 13
Phase 1: LAG525 3 mg/kg Q2W

Single-agent LAG525 3 mg/kg Q2W

2 / 1211 / 120 / 12
Phase 1: LAG525 5 mg/kg Q2W

Single-agent LAG525 5 mg/kg Q2W

5 / 66 / 60 / 6
Phase 1: LAG525 10 mg/kg Q2W

Single-agent LAG525 10 mg/kg Q2W

2 / 66 / 60 / 6
Phase 1: LAG525 15 mg/kg Q2W

Single-agent LAG525 15 mg/kg Q2W

3 / 66 / 60 / 6
Phase 1: LAG525 240 mg Q2W

Single-agent LAG525 240 mg Q2W (ROW patients)

10 / 2524 / 255 / 25
Phase 1: LAG525 400 mg Q2W

Single-agent LAG525 400 mg Q2W (ROW patients)

11 / 2424 / 243 / 24
Phase 1: LAG525 1 mg/kg Q2W-JP

Single-agent LAG525 1 mg/kg Q2W (Japanese patients)

0 / 44 / 40 / 4
Phase 1: LAG525 240 mg Q2W-JP

Single-agent LAG525 240 mg Q2W (Japanese patients)

2 / 55 / 50 / 5
Phase 1: LAG525 400 mg Q2W-JP

Single-agent LAG525 400 mg Q2W (Japanese patients)

0 / 66 / 60 / 6
Phase 1: LAG525 3 mg/kg Q4W

Single-agent LAG525 3 mg/kg Q4W

2 / 55 / 50 / 5
Phase 1: LAG525 5 mg/kg Q4W

Single-agent LAG525 5 mg/kg Q4W

4 / 66 / 60 / 6
Phase 1: LAG525 10 mg/kg Q4W

Single-agent LAG525 10 mg/kg Q4W

5 / 1111 / 111 / 11
Phase 1: LAG525 400 mg Q4W

Single-agent LAG525 400 mg Q4W

2 / 55 / 50 / 5
Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W

Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)

3 / 66 / 60 / 6
Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W

Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)

2 / 66 / 60 / 6
Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W

Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)

3 / 66 / 61 / 6
Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W

Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)

3 / 55 / 51 / 5
Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W

Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)

1 / 66 / 60 / 6
Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W

Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)

9 / 2019 / 201 / 20
Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W

Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)

3 / 65 / 60 / 6
Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W

Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)

6 / 1212 / 122 / 12
Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W

Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)

4 / 77 / 71 / 7
Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W

Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)

5 / 66 / 60 / 6
Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W

Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)

5 / 1212 / 121 / 12
Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W

Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)

2 / 66 / 60 / 6
Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W

Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)

5 / 1111 / 110 / 11
Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W

Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)

4 / 66 / 61 / 6
Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W

Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)

4 / 66 / 61 / 6
Phase 2: Naive - NSCLC - LAG525 400 mg Q3W + PDR001 300 mg Q3W

Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients with NSCLC naïve to anti-PD-1/PD-L1

13 / 2019 / 201 / 20
Phase 2: Naive - Melanoma - LAG525 400 mg Q3W + PDR001 300 mg Q3W

Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients with melanoma naïve to anti-PD-1/PD-L1

8 / 2017 / 203 / 20
Phase 2: Naive - RCC - LAG525 400 mg Q3W + PDR001 300 mg Q3W

Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients with RCC naïve to anti-PD-1/PD-L1

14 / 1919 / 192 / 19
Phase 2: Naive - Mesothelioma - LAG525 400 mg Q3W + PDR001 300 mg Q3W

Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients with mesothelioma naïve to anti-PD-1/PD-L1

15 / 4141 / 411 / 41
Phase 2: Naive - TNBC - LAG525 400 mg Q3W + PDR001 300 mg Q3W

Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients with TNBC naïve to anti-PD-1/PD-L1

9 / 2121 / 211 / 21
Phase 2: Naive - TNBC - LAG525 600 mg Q4W + PDR001 400 mg Q4W

Combination LAG525 600 mg + PDR001 400 mg (Q4W/Q4W) in patients with TNBC naïve to anti-PD-1/PD-L1

10 / 2121 / 211 / 21
Phase 2: Pre-treated -NSCLC - LAG525 400 mg Q3W + PDR001 300 mg Q3W

Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients with NSCLC pre-treated with anti-PD-1/PD-L1

7 / 2221 / 221 / 22
Phase 2: Pre-treated - Melanoma - LAG525 400 mg Q3W + PDR001 300 mg Q3W

Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients with melanoma pre-treated with anti-PD-1/PD-L1

8 / 2222 / 221 / 22
Phase 2: Pre-treated - RCC - LAG525 400 mg Q3W + PDR001 300 mg Q3W

Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients with RCC pre-treated with anti-PD-1/PD-L1

5 / 1919 / 190 / 19
Phase 2: Pre-treated - Mesothelioma - LAG525 400 mg Q3W + PDR001 300 mg Q3W

Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients with mesothelioma pre-treated with anti-PD-1/PD-L1

4 / 1616 / 162 / 16
Phase 2: Pre-treated - TNBC - LAG525 400 mg Q3W + PDR001 300 mg Q3W

Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients with TNBC pre-treated with anti-PD-1/PD-L1

4 / 1414 / 141 / 14
All Patients

All patients

208 / 490481 / 49033 / 490

Group identifiers: EG000: Phase 1: LAG525 1 mg/kg Q2W · EG001: Phase 1: LAG525 3 mg/kg Q2W · EG002: Phase 1: LAG525 5 mg/kg Q2W · EG003: Phase 1: LAG525 10 mg/kg Q2W · EG004: Phase 1: LAG525 15 mg/kg Q2W · EG005: Phase 1: LAG525 240 mg Q2W · EG006: Phase 1: LAG525 400 mg Q2W · EG007: Phase 1: LAG525 1 mg/kg Q2W-JP · EG008: Phase 1: LAG525 240 mg Q2W-JP · EG009: Phase 1: LAG525 400 mg Q2W-JP · EG010: Phase 1: LAG525 3 mg/kg Q4W · EG011: Phase 1: LAG525 5 mg/kg Q4W · EG012: Phase 1: LAG525 10 mg/kg Q4W · EG013: Phase 1: LAG525 400 mg Q4W · EG014: Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W · EG015: Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W · EG016: Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W · EG017: Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W · EG018: Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W · EG019: Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W · EG020: Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W · EG021: Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W · EG022: Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W · EG023: Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W · EG024: Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W · EG025: Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W · EG026: Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W · EG027: Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W · EG028: Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W · EG029: Phase 2: Naive - NSCLC - LAG525 400 mg Q3W + PDR001 300 mg Q3W · EG030: Phase 2: Naive - Melanoma - LAG525 400 mg Q3W + PDR001 300 mg Q3W · EG031: Phase 2: Naive - RCC - LAG525 400 mg Q3W + PDR001 300 mg Q3W · EG032: Phase 2: Naive - Mesothelioma - LAG525 400 mg Q3W + PDR001 300 mg Q3W · EG033: Phase 2: Naive - TNBC - LAG525 400 mg Q3W + PDR001 300 mg Q3W · EG034: Phase 2: Naive - TNBC - LAG525 600 mg Q4W + PDR001 400 mg Q4W · EG035: Phase 2: Pre-treated -NSCLC - LAG525 400 mg Q3W + PDR001 300 mg Q3W · EG036: Phase 2: Pre-treated - Melanoma - LAG525 400 mg Q3W + PDR001 300 mg Q3W · EG037: Phase 2: Pre-treated - RCC - LAG525 400 mg Q3W + PDR001 300 mg Q3W · EG038: Phase 2: Pre-treated - Mesothelioma - LAG525 400 mg Q3W + PDR001 300 mg Q3W · EG039: Phase 2: Pre-treated - TNBC - LAG525 400 mg Q3W + PDR001 300 mg Q3W · EG040: All Patients

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 (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      6
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      6
    term
    Leukocytosis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      6
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      6
    term
    Atrial fibrillation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      6
    term
    Cardiac tamponade
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      6
    term
    Coronary artery disease
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      6
    term
    Sinus tachycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      6
    term
    Vertigo
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      6
    term
    Adrenal insufficiency
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      6
    term
    Hypophysitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      6
    term
    Hypothyroidism
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      6
    term
    Eyelid ptosis

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 (23.1)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      6
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      3
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      3
      num At Risk
      6
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      6
    term
    Disseminated intravascular coagulation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      6
    term
    Iron deficiency anaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      6
    term
    Leukocytosis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      6
    term
    Leukopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      6
    term
    Lymphadenopathy
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      6
    term
    Lymphopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      6
    term
    Neutropenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      6
    term
    Thrombocytopenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      6
    term
    Thrombocytosis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      6
    term
    Aortic valve disease
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      6
    term
    Atrial flutter
Complete source fields
description
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
event Groups
  1. deaths Num Affected
    1
    deaths Num At Risk
    13
    description
    Single-agent LAG525 1 mg/kg Q2W (ROW patients)
    id
    EG000
    other Num Affected
    13
    other Num At Risk
    13
    serious Num Affected
    4
    serious Num At Risk
    13
    title
    Phase 1: LAG525 1 mg/kg Q2W
  2. deaths Num Affected
    0
    deaths Num At Risk
    12
    description
    Single-agent LAG525 3 mg/kg Q2W
    id
    EG001
    other Num Affected
    11
    other Num At Risk
    12
    serious Num Affected
    2
    serious Num At Risk
    12
    title
    Phase 1: LAG525 3 mg/kg Q2W
  3. deaths Num Affected
    0
    deaths Num At Risk
    6
    description
    Single-agent LAG525 5 mg/kg Q2W
    id
    EG002
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    5
    serious Num At Risk
    6
    title
    Phase 1: LAG525 5 mg/kg Q2W
  4. deaths Num Affected
    0
    deaths Num At Risk
    6
    description
    Single-agent LAG525 10 mg/kg Q2W
    id
    EG003
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    2
    serious Num At Risk
    6
    title
    Phase 1: LAG525 10 mg/kg Q2W
  5. deaths Num Affected
    0
    deaths Num At Risk
    6
    description
    Single-agent LAG525 15 mg/kg Q2W
    id
    EG004
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    3
    serious Num At Risk
    6
    title
    Phase 1: LAG525 15 mg/kg Q2W
  6. deaths Num Affected
    5
    deaths Num At Risk
    25
    description
    Single-agent LAG525 240 mg Q2W (ROW patients)
    id
    EG005
    other Num Affected
    24
    other Num At Risk
    25
    serious Num Affected
    10
    serious Num At Risk
    25
    title
    Phase 1: LAG525 240 mg Q2W
  7. deaths Num Affected
    3
    deaths Num At Risk
    24
    description
    Single-agent LAG525 400 mg Q2W (ROW patients)
    id
    EG006
    other Num Affected
    24
    other Num At Risk
    24
    serious Num Affected
    11
    serious Num At Risk
    24
    title
    Phase 1: LAG525 400 mg Q2W
  8. deaths Num Affected
    0
    deaths Num At Risk
    4
    description
    Single-agent LAG525 1 mg/kg Q2W (Japanese patients)
    id
    EG007
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    0
    serious Num At Risk
    4
    title
    Phase 1: LAG525 1 mg/kg Q2W-JP
  9. deaths Num Affected
    0
    deaths Num At Risk
    5
    description
    Single-agent LAG525 240 mg Q2W (Japanese patients)
    id
    EG008
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    2
    serious Num At Risk
    5
    title
    Phase 1: LAG525 240 mg Q2W-JP
  10. deaths Num Affected
    0
    deaths Num At Risk
    6
    description
    Single-agent LAG525 400 mg Q2W (Japanese patients)
    id
    EG009
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    0
    serious Num At Risk
    6
    title
    Phase 1: LAG525 400 mg Q2W-JP
  11. deaths Num Affected
    0
    deaths Num At Risk
    5
    description
    Single-agent LAG525 3 mg/kg Q4W
    id
    EG010
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    2
    serious Num At Risk
    5
    title
    Phase 1: LAG525 3 mg/kg Q4W
  12. deaths Num Affected
    0
    deaths Num At Risk
    6
    description
    Single-agent LAG525 5 mg/kg Q4W
    id
    EG011
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    4
    serious Num At Risk
    6
    title
    Phase 1: LAG525 5 mg/kg Q4W
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      6
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      3
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      3
      num At Risk
      6
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      6
    term
    Disseminated intravascular coagulation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      6
    term
    Iron deficiency anaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      6
    term
    Leukocytosis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      6
    term
    Leukopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      6
    term
    Lymphadenopathy
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      6
    term
    Lymphopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      6
    term
    Neutropenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      6
    term
    Thrombocytopenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      6
    term
    Thrombocytosis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      6
    term
    Aortic valve disease
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      6
    term
    Atrial flutter
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      6
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      6
    term
    Leukocytosis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      6
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      6
    term
    Atrial fibrillation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      6
    term
    Cardiac tamponade
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      6
    term
    Coronary artery disease
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      6
    term
    Sinus tachycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      6
    term
    Vertigo
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      6
    term
    Adrenal insufficiency
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      6
    term
    Hypophysitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      6
    term
    Hypothyroidism
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      25
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      6
    term
    Eyelid ptosis
time Frame
From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).

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Preserved source evidence · Not medical advice