Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01321554 · ADVERSE EVENTS

Adverse events

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Trial of Lenvatinib (E7080) in 131I-Refractory Differentiated Thyroid Cancer (DTC) · Source last updated 2023-06-22

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
For each participant, from the first dose till 30 days after the last dose up to approximately 8 years
Other-event reporting threshold
5%

Safety was assessed by the monitoring and recording of all adverse events (AEs) and serious adverse events (SAEs); regular monitoring of hematology, clinical chemistry, and urine values; physical examinations; and regular measurement of vital signs, electrocardiograms (ECG), and echocardiograms.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Randomization Phase: Lenvatinib 24 mg

Participants received lenvatinib 24 mg, hard capsule, orally, once daily, until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.

171 / 261259 / 261161 / 261
Randomization Phase: Placebo

Participants received matching-placebo, hard capsule, orally, once daily until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.

31 / 131118 / 13113 / 16
OOL, Treatment Period: Lenvatinib 24 mg

Participants received lenvatinib 24 mg, hard capsule, orally, once daily in Treatment Period. Placebo treated participants in the Randomization Phase who had progressive disease confirmed by IIR, and who requested treatment with lenvatinib.

62 / 8584 / 8562 / 85
OOL, Treatment Period: Lenvatinib 20 mg

Participants received lenvatinib 20 mg, hard capsule, orally, once daily in Treatment Period. Placebo treated participants in the Randomization Phase who had progressive disease confirmed by IIR, and who requested treatment with lenvatinib.

16 / 3029 / 3015 / 30

Group identifiers: EG000: Randomization Phase: Lenvatinib 24 mg · EG001: Randomization Phase: Placebo · EG002: OOL, Treatment Period: Lenvatinib 24 mg · EG003: OOL, Treatment Period: Lenvatinib 20 mg

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
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      261
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      131
      num Events
      0
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      85
      num Events
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      261
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      131
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      85
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      30
      num Events
      1
    term
    Anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      261
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      131
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      85
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    term
    Abscess intestinal
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      261
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      131
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      85
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      261
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      131
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      85
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      261
      num Events
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      131
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      85
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    term
    Acute myocardial infarction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      261
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      131
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      85
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    term
    Angina pectoris
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      261
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      131
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      85
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    term
    Acute respiratory distress syndrome
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      261
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      131
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      85
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    term
    Bundle branch block right
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      261
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      131
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      85
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    term
    Cardio-respiratory arrest
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      261
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      131
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      85
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    term
    Coronary artery stenosis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      261
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      131
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      85
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    term
    Myocardial infarction

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 18.0
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      261
      num Events
      60
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      131
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      85
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    term
    Lymphopenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Reproductive system and breast disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      261
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      131
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      85
      num Events
      0
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      30
      num Events
      4
    term
    Pelvic pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      261
      num Events
      108
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      131
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      85
      num Events
      2
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      30
      num Events
      7
    term
    Platelet count decreased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      261
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      131
      num Events
      0
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      85
      num Events
      5
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      30
      num Events
      4
    term
    Dermatitis acneiform
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      261
      num Events
      26
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      131
      num Events
      0
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      85
      num Events
      7
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      30
      num Events
      2
    term
    Hypothyroidism
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      261
      num Events
      30
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      131
      num Events
      2
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      85
      num Events
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    term
    Aspartate aminotransferase increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      261
      num Events
      20
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      131
      num Events
      0
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      85
      num Events
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    term
    Blood thyroid stimulating hormone increased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      261
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      131
      num Events
      0
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      85
      num Events
      12
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      30
      num Events
      5
    term
    Hypotension
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      261
      num Events
      60
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      131
      num Events
      13
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      85
      num Events
      11
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      30
      num Events
      11
    term
    Anaemia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      261
      num Events
      44
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      131
      num Events
      3
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      85
      num Events
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    term
    Oral pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      261
      num Events
      54
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      131
      num Events
      9
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      85
      num Events
      8
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      30
      num Events
      4
    term
    Urinary tract infection
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      261
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      131
      num Events
      0
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      85
      num Events
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    term
    Cheilitis
Complete source fields
description
Safety was assessed by the monitoring and recording of all adverse events (AEs) and serious adverse events (SAEs); regular monitoring of hematology, clinical chemistry, and urine values; physical examinations; and regular measurement of vital signs, electrocardiograms (ECG), and echocardiograms.
event Groups
  1. deaths Num Affected
    161
    deaths Num At Risk
    261
    description
    Participants received lenvatinib 24 mg, hard capsule, orally, once daily, until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
    id
    EG000
    other Num Affected
    259
    other Num At Risk
    261
    serious Num Affected
    171
    serious Num At Risk
    261
    title
    Randomization Phase: Lenvatinib 24 mg
  2. deaths Num Affected
    13
    deaths Num At Risk
    16
    description
    Participants received matching-placebo, hard capsule, orally, once daily until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
    id
    EG001
    other Num Affected
    118
    other Num At Risk
    131
    serious Num Affected
    31
    serious Num At Risk
    131
    title
    Randomization Phase: Placebo
  3. deaths Num Affected
    62
    deaths Num At Risk
    85
    description
    Participants received lenvatinib 24 mg, hard capsule, orally, once daily in Treatment Period. Placebo treated participants in the Randomization Phase who had progressive disease confirmed by IIR, and who requested treatment with lenvatinib.
    id
    EG002
    other Num Affected
    84
    other Num At Risk
    85
    serious Num Affected
    62
    serious Num At Risk
    85
    title
    OOL, Treatment Period: Lenvatinib 24 mg
  4. deaths Num Affected
    15
    deaths Num At Risk
    30
    description
    Participants received lenvatinib 20 mg, hard capsule, orally, once daily in Treatment Period. Placebo treated participants in the Randomization Phase who had progressive disease confirmed by IIR, and who requested treatment with lenvatinib.
    id
    EG003
    other Num Affected
    29
    other Num At Risk
    30
    serious Num Affected
    16
    serious Num At Risk
    30
    title
    OOL, Treatment Period: Lenvatinib 20 mg
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      261
      num Events
      60
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      131
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      85
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    term
    Lymphopenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Reproductive system and breast disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      261
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      131
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      85
      num Events
      0
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      30
      num Events
      4
    term
    Pelvic pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      261
      num Events
      108
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      131
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      85
      num Events
      2
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      30
      num Events
      7
    term
    Platelet count decreased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      261
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      131
      num Events
      0
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      85
      num Events
      5
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      30
      num Events
      4
    term
    Dermatitis acneiform
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      261
      num Events
      26
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      131
      num Events
      0
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      85
      num Events
      7
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      30
      num Events
      2
    term
    Hypothyroidism
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      261
      num Events
      30
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      131
      num Events
      2
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      85
      num Events
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    term
    Aspartate aminotransferase increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      261
      num Events
      20
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      131
      num Events
      0
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      85
      num Events
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    term
    Blood thyroid stimulating hormone increased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      261
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      131
      num Events
      0
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      85
      num Events
      12
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      30
      num Events
      5
    term
    Hypotension
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      261
      num Events
      60
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      131
      num Events
      13
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      85
      num Events
      11
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      30
      num Events
      11
    term
    Anaemia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      261
      num Events
      44
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      131
      num Events
      3
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      85
      num Events
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    term
    Oral pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      261
      num Events
      54
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      131
      num Events
      9
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      85
      num Events
      8
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      30
      num Events
      4
    term
    Urinary tract infection
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      261
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      131
      num Events
      0
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      85
      num Events
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    term
    Cheilitis
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      261
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      131
      num Events
      0
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      85
      num Events
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      261
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      131
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      85
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      30
      num Events
      1
    term
    Anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      261
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      131
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      85
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    term
    Abscess intestinal
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      261
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      131
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      85
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      261
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      131
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      85
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      261
      num Events
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      131
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      85
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    term
    Acute myocardial infarction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      261
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      131
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      85
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    term
    Angina pectoris
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      261
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      131
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      85
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    term
    Acute respiratory distress syndrome
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      261
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      131
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      85
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    term
    Bundle branch block right
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      261
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      131
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      85
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    term
    Cardio-respiratory arrest
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      261
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      131
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      85
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    term
    Coronary artery stenosis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      261
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      131
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      85
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    term
    Myocardial infarction
time Frame
For each participant, from the first dose till 30 days after the last dose up to approximately 8 years

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice