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NCT02535312 · ADVERSE EVENTS

Adverse events

Methoxyamine, Cisplatin, and Pemetrexed Disodium in Treating Patients With Advanced Solid Tumors or Mesothelioma That Cannot Be Removed by Surgery or Mesothelioma That Is Refractory to Pemetrexed Disodium and Cisplatin or Carboplatin · Source last updated 2026-07-31

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

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

Collection time frame
Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
Other-event reporting threshold
0%

"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm A, Dose Level 1 - 50mg TRC102, 60mg/m^2 Cisplatin (Phase I)

TRC102 50 mg PO days 1-4; Pemetrex 500 mg/m\^2 IV over 10 min day1; Cisplatin 60 mg/m\^2 IV over 30-60 min day1

0 / 33 / 30 / 3
Arm A, Dose Level 2 - 75mg TRC102, 60mg/m^2 Cisplatin (Phase I)

TRC102 75 mg PO days 1-4; Pemetrex 500 mg/m\^2 IV over 10 min day1; Cisplatin 60 mg/m\^2 IV over 30-60 min day1

3 / 44 / 42 / 4
Arm A, Dose Level 3 - 100mg TRC102, 60mg/m^2 Cisplatin (Phase I)

TRC102 100 mg PO days 1-4; Pemetrex 500 mg/m\^2 IV over 10 min day1; Cisplatin 60 mg/m\^2 IV over 30-60 min day1

2 / 33 / 32 / 3
Arm A, Dose Level 4 - 100mg TRC102, 75mg/m^2 Cisplatin (Phase I)

TRC102 100 mg PO days 1-4; Pemetrex 500 mg/m\^2 IV over 10 min day1; Cisplatin 75 mg/m\^2 IV over 30-60 min day1

3 / 66 / 60 / 6
Arm B, Dose Level 1 - 50mg TRC102 (Phase II)

TRC102 50mg PO on days 1-4; Pemetrex 500mg/m\^2 IV over 10 min day 1

9 / 1414 / 146 / 14

Group identifiers: EG000: Arm A, Dose Level 1 - 50mg TRC102, 60mg/m^2 Cisplatin (Phase I) · EG001: Arm A, Dose Level 2 - 75mg TRC102, 60mg/m^2 Cisplatin (Phase I) · EG002: Arm A, Dose Level 3 - 100mg TRC102, 60mg/m^2 Cisplatin (Phase I) · EG003: Arm A, Dose Level 4 - 100mg TRC102, 75mg/m^2 Cisplatin (Phase I) · EG004: Arm B, Dose Level 1 - 50mg TRC102 (Phase II)

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Anemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Febrile neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      14
      num Events
      1
    term
    Heart failure
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      14
      num Events
      1
    term
    Sinus bradycardia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Sinus tachycardia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      14
      num Events
      1
    term
    Abdominal pain
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Nausea
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Vomiting
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      14
      num Events
      1
    term
    Disease Progression
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      14
      num Events
      1
    term
    Fatigue
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Fever
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      14
      num Events
      1
    term
    Non-cardiac chest pain

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
      num Events
      11
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      4
      num Events
      19
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      3
      num Events
      70
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      6
      num Events
      52
    5. group Id
      EG004
      num Affected
      10
      num At Risk
      14
      num Events
      89
    term
    Anemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      14
      num Events
      4
    term
    LDH Increased
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      14
      num Events
      1
    term
    nose bleed
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
      num Events
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
      num Events
      3
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      3
      num Events
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      4
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      14
      num Events
      4
    term
    Sinus bradycardia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
      num Events
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      6
      num Events
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      14
      num Events
      1
    term
    Sinus tachycardia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Ear infection
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Ear pain
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Hearing impaired
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      14
      num Events
      6
    term
    Blurred vision
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      14
      num Events
      2
    term
    Dry eye
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      14
      num Events
      1
    term
    Flashing lights
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      14
      num Events
      1
    term
    Unequal Pupil Dilation
Complete source fields
description
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    3
    description
    TRC102 50 mg PO days 1-4; Pemetrex 500 mg/m\^2 IV over 10 min day1; Cisplatin 60 mg/m\^2 IV over 30-60 min day1
    id
    EG000
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    0
    serious Num At Risk
    3
    title
    Arm A, Dose Level 1 - 50mg TRC102, 60mg/m^2 Cisplatin (Phase I)
  2. deaths Num Affected
    2
    deaths Num At Risk
    4
    description
    TRC102 75 mg PO days 1-4; Pemetrex 500 mg/m\^2 IV over 10 min day1; Cisplatin 60 mg/m\^2 IV over 30-60 min day1
    id
    EG001
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    3
    serious Num At Risk
    4
    title
    Arm A, Dose Level 2 - 75mg TRC102, 60mg/m^2 Cisplatin (Phase I)
  3. deaths Num Affected
    2
    deaths Num At Risk
    3
    description
    TRC102 100 mg PO days 1-4; Pemetrex 500 mg/m\^2 IV over 10 min day1; Cisplatin 60 mg/m\^2 IV over 30-60 min day1
    id
    EG002
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    2
    serious Num At Risk
    3
    title
    Arm A, Dose Level 3 - 100mg TRC102, 60mg/m^2 Cisplatin (Phase I)
  4. deaths Num Affected
    0
    deaths Num At Risk
    6
    description
    TRC102 100 mg PO days 1-4; Pemetrex 500 mg/m\^2 IV over 10 min day1; Cisplatin 75 mg/m\^2 IV over 30-60 min day1
    id
    EG003
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    3
    serious Num At Risk
    6
    title
    Arm A, Dose Level 4 - 100mg TRC102, 75mg/m^2 Cisplatin (Phase I)
  5. deaths Num Affected
    6
    deaths Num At Risk
    14
    description
    TRC102 50mg PO on days 1-4; Pemetrex 500mg/m\^2 IV over 10 min day 1
    id
    EG004
    other Num Affected
    14
    other Num At Risk
    14
    serious Num Affected
    9
    serious Num At Risk
    14
    title
    Arm B, Dose Level 1 - 50mg TRC102 (Phase II)
frequency Threshold
0
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
      num Events
      11
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      4
      num Events
      19
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      3
      num Events
      70
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      6
      num Events
      52
    5. group Id
      EG004
      num Affected
      10
      num At Risk
      14
      num Events
      89
    term
    Anemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      14
      num Events
      4
    term
    LDH Increased
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      14
      num Events
      1
    term
    nose bleed
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
      num Events
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
      num Events
      3
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      3
      num Events
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      4
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      14
      num Events
      4
    term
    Sinus bradycardia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
      num Events
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      6
      num Events
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      14
      num Events
      1
    term
    Sinus tachycardia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Ear infection
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Ear pain
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Hearing impaired
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      14
      num Events
      6
    term
    Blurred vision
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      14
      num Events
      2
    term
    Dry eye
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      14
      num Events
      1
    term
    Flashing lights
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      14
      num Events
      1
    term
    Unequal Pupil Dilation
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Anemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Febrile neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      14
      num Events
      1
    term
    Heart failure
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      14
      num Events
      1
    term
    Sinus bradycardia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Sinus tachycardia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      14
      num Events
      1
    term
    Abdominal pain
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Nausea
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Vomiting
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      14
      num Events
      1
    term
    Disease Progression
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      14
      num Events
      1
    term
    Fatigue
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Fever
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      14
      num Events
      1
    term
    Non-cardiac chest pain
time Frame
Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.

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Preserved source evidence · Not medical advice