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NCT01139775 · ADVERSE EVENTS

Adverse events

A Study in Non Small Cell Lung Cancer · Source last updated 2018-05-18

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
Not reported
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Phase 1: Pemetrexed + Cisplatin + LY2603618

Cycles 1-2 (21-day cycle): Day 1: pemetrexed 500 mg/m\^2 + cisplatin 75 mg/m\^2 Day 2: LY2603618 130 to 275 mg After 2 cycles, participants may have continued on study drug until disease progression, unacceptable toxicity, or other withdrawal criterion was met. Pemetrexed, cisplatin, and LY2603618 were administered IV over 10 minutes, 1 hour, and 1 hour, respectively.

1 / 1414 / 14Not reported / Not reported
Phase 2: Pemetrexed + Cisplatin + LY2603618

Cycles 1-4 (21-day cycle): Before 25 Oct 2012: Day 1: pemetrexed 500 mg/m\^2 + cisplatin 75 mg/m\^2 Day 2: LY2603618 dose determined from phase 1 (275 mg) After 25 Oct 2012: Day 1: pemetrexed 500 mg/m\^2 + cisplatin 75 mg/m\^2 After 4 cycles, participants may have continued on maintenance therapy until disease progression, unacceptable toxicity, or other withdrawal criterion was met. Maintenance therapy (every 21 days): Before 25 Oct 2012: Day 1: pemetrexed 500 mg/m\^2 Day 2: LY2603618 dose determined from phase 1 (275 mg) After 25 Oct 2012: Day 1: pemetrexed 500 mg/m\^2 If, as of 25 Oct 2012, the participant was in maintenance therapy and randomized to the experimental arm, the participant was eligible to continue with pemetrexed/LY2603618 therapy if the investigator deemed it was in the participant's best interest and the participant consented. Pemetrexed, cisplatin, and LY2603618 were administered IV over 10 minutes, 1 hour, and 1 hour, respectively.

16 / 3937 / 39Not reported / Not reported
Phase 2: Pemetrexed + Cisplatin

Cycles 1-4 (21-day cycle): Day 1: pemetrexed 500 mg/m\^2 + cisplatin 75 mg/m\^2 After 4 cycles, participants may have continued on maintenance therapy until disease progression, unacceptable toxicity, or other withdrawal criterion was met. Maintenance therapy (every 21 days): Day 1: pemetrexed 500 mg/m\^2 Pemetrexed was administered IV over 10 minutes, and cisplatin was administered IV over 1 hour.

6 / 2222 / 22Not reported / Not reported

Group identifiers: EG000: Phase 1: Pemetrexed + Cisplatin + LY2603618 · EG001: Phase 2: Pemetrexed + Cisplatin + LY2603618 · EG002: Phase 2: Pemetrexed + Cisplatin

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 16.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      39
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      39
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Angina pectoris
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      39
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Atrial fibrillation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      22
      num Events
      1
    term
    Ileus
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      39
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      22
      num Events
      1
    term
    Nausea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      22
      num Events
      1
    term
    Vomiting
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      39
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Death
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      22
      num Events
      1
    term
    Pyrexia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      39
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      22
      num Events
      1
    term
    Infection
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      39
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Pneumonia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      39
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Urinary tract infection bacterial

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 16.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      14
      num Events
      16
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      39
      num Events
      16
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      22
      num Events
      6
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      22
      num Events
      2
    term
    Leukocytosis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      2
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      39
      num Events
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Leukopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Lymphopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      14
      num Events
      13
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      39
      num Events
      11
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      22
      num Events
      7
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      14
      num Events
      10
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      39
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      22
      num Events
      1
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Thrombocytosis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
      num Events
      0
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      39
      num Events
      22
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      22
      num Events
      2
    term
    Ototoxicity
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      14
      num Events
      4
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      39
      num Events
      7
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      22
      num Events
      2
    term
    Tinnitus
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      14
      num Events
      4
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      39
      num Events
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      22
      num Events
      1
    term
    Vertigo
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      9
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      39
      num Events
      3
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      22
      num Events
      4
    term
    Conjunctivitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      39
      num Events
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      22
      num Events
      1
    term
    Eye oedema
Complete source fields
event Groups
  1. description
    Cycles 1-2 (21-day cycle): Day 1: pemetrexed 500 mg/m\^2 + cisplatin 75 mg/m\^2 Day 2: LY2603618 130 to 275 mg After 2 cycles, participants may have continued on study drug until disease progression, unacceptable toxicity, or other withdrawal criterion was met. Pemetrexed, cisplatin, and LY2603618 were administered IV over 10 minutes, 1 hour, and 1 hour, respectively.
    id
    EG000
    other Num Affected
    14
    other Num At Risk
    14
    serious Num Affected
    1
    serious Num At Risk
    14
    title
    Phase 1: Pemetrexed + Cisplatin + LY2603618
  2. description
    Cycles 1-4 (21-day cycle): Before 25 Oct 2012: Day 1: pemetrexed 500 mg/m\^2 + cisplatin 75 mg/m\^2 Day 2: LY2603618 dose determined from phase 1 (275 mg) After 25 Oct 2012: Day 1: pemetrexed 500 mg/m\^2 + cisplatin 75 mg/m\^2 After 4 cycles, participants may have continued on maintenance therapy until disease progression, unacceptable toxicity, or other withdrawal criterion was met. Maintenance therapy (every 21 days): Before 25 Oct 2012: Day 1: pemetrexed 500 mg/m\^2 Day 2: LY2603618 dose determined from phase 1 (275 mg) After 25 Oct 2012: Day 1: pemetrexed 500 mg/m\^2 If, as of 25 Oct 2012, the participant was in maintenance therapy and randomized to the experimental arm, the participant was eligible to continue with pemetrexed/LY2603618 therapy if the investigator deemed it was in the participant's best interest and the participant consented. Pemetrexed, cisplatin, and LY2603618 were administered IV over 10 minutes, 1 hour, and 1 hour, respectively.
    id
    EG001
    other Num Affected
    37
    other Num At Risk
    39
    serious Num Affected
    16
    serious Num At Risk
    39
    title
    Phase 2: Pemetrexed + Cisplatin + LY2603618
  3. description
    Cycles 1-4 (21-day cycle): Day 1: pemetrexed 500 mg/m\^2 + cisplatin 75 mg/m\^2 After 4 cycles, participants may have continued on maintenance therapy until disease progression, unacceptable toxicity, or other withdrawal criterion was met. Maintenance therapy (every 21 days): Day 1: pemetrexed 500 mg/m\^2 Pemetrexed was administered IV over 10 minutes, and cisplatin was administered IV over 1 hour.
    id
    EG002
    other Num Affected
    22
    other Num At Risk
    22
    serious Num Affected
    6
    serious Num At Risk
    22
    title
    Phase 2: Pemetrexed + Cisplatin
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      14
      num Events
      16
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      39
      num Events
      16
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      22
      num Events
      6
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      22
      num Events
      2
    term
    Leukocytosis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      2
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      39
      num Events
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Leukopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Lymphopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      14
      num Events
      13
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      39
      num Events
      11
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      22
      num Events
      7
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      14
      num Events
      10
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      39
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      22
      num Events
      1
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Thrombocytosis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
      num Events
      0
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      39
      num Events
      22
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      22
      num Events
      2
    term
    Ototoxicity
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      14
      num Events
      4
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      39
      num Events
      7
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      22
      num Events
      2
    term
    Tinnitus
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      14
      num Events
      4
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      39
      num Events
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      22
      num Events
      1
    term
    Vertigo
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      9
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      39
      num Events
      3
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      22
      num Events
      4
    term
    Conjunctivitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      39
      num Events
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      22
      num Events
      1
    term
    Eye oedema
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      39
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      39
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Angina pectoris
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      39
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Atrial fibrillation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      22
      num Events
      1
    term
    Ileus
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      39
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      22
      num Events
      1
    term
    Nausea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      22
      num Events
      1
    term
    Vomiting
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      39
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Death
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      22
      num Events
      1
    term
    Pyrexia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      39
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      22
      num Events
      1
    term
    Infection
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      39
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Pneumonia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      39
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Urinary tract infection bacterial

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Preserved source evidence · Not medical advice