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NCT00094653 · ADVERSE EVENTS

Adverse events

MDX-010 Antibody, MDX-1379 Melanoma Vaccine, or MDX-010/MDX-1379 Combination Treatment for Patients With Unresectable or Metastatic Melanoma · Source last updated 2011-07-11

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
Ipilimumab Monotherapy

Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.

55 / 131124 / 131Not reported / Not reported
Ipilimumab Plus gp100

Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288\[288V\]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217\[210M\]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.

155 / 380362 / 380Not reported / Not reported
gp100

Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288\[288V\]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217\[210M\]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.

52 / 132124 / 132Not reported / Not reported

Group identifiers: EG000: Ipilimumab Monotherapy · EG001: Ipilimumab Plus gp100 · EG002: gp100

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 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      380
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      132
    term
    ABDOMINAL DISTENSION
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      380
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      132
    term
    ABDOMINAL PAIN
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      380
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      132
    term
    ABDOMINAL PAIN UPPER
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      380
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      132
    term
    ABDOMINAL WALL MASS
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      380
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      132
    term
    ACCIDENTAL OVERDOSE
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      380
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      132
    term
    ACUTE HEPATIC FAILURE
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      380
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      132
    term
    ACUTE PULMONARY OEDEMA
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      380
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      132
    term
    ACUTE RESPIRATORY DISTRESS SYNDROME
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      380
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      132
    term
    ADRENAL INSUFFICIENCY
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      380
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      132
    term
    ADVERSE EVENT
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      380
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      132
    term
    ANAEMIA
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      380
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      132
    term
    ANGIOPATHY

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
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      380
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      132
    term
    ABDOMINAL DISTENSION
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      64
      num At Risk
      380
    3. group Id
      EG002
      num Affected
      18
      num At Risk
      132
    term
    ABDOMINAL PAIN
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      380
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      132
    term
    ABDOMINAL PAIN UPPER
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      380
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      132
    term
    ADVERSE EVENT
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      380
    3. group Id
      EG002
      num Affected
      22
      num At Risk
      132
    term
    ANAEMIA
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      380
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      132
    term
    ANXIETY
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      380
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      132
    term
    ARTHRALGIA
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      37
      num At Risk
      380
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      132
    term
    ASTHENIA
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      380
    3. group Id
      EG002
      num Affected
      16
      num At Risk
      132
    term
    BACK PAIN
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      380
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      132
    term
    CHILLS
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      79
      num At Risk
      380
    3. group Id
      EG002
      num Affected
      34
      num At Risk
      132
    term
    CONSTIPATION
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      55
      num At Risk
      380
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      132
    term
    COUGH
Complete source fields
event Groups
  1. description
    Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
    id
    EG000
    other Num Affected
    124
    other Num At Risk
    131
    serious Num Affected
    55
    serious Num At Risk
    131
    title
    Ipilimumab Monotherapy
  2. description
    Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288\[288V\]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217\[210M\]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
    id
    EG001
    other Num Affected
    362
    other Num At Risk
    380
    serious Num Affected
    155
    serious Num At Risk
    380
    title
    Ipilimumab Plus gp100
  3. description
    Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288\[288V\]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217\[210M\]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
    id
    EG002
    other Num Affected
    124
    other Num At Risk
    132
    serious Num Affected
    52
    serious Num At Risk
    132
    title
    gp100
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      380
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      132
    term
    ABDOMINAL DISTENSION
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      64
      num At Risk
      380
    3. group Id
      EG002
      num Affected
      18
      num At Risk
      132
    term
    ABDOMINAL PAIN
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      380
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      132
    term
    ABDOMINAL PAIN UPPER
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      380
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      132
    term
    ADVERSE EVENT
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      380
    3. group Id
      EG002
      num Affected
      22
      num At Risk
      132
    term
    ANAEMIA
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      380
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      132
    term
    ANXIETY
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      380
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      132
    term
    ARTHRALGIA
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      37
      num At Risk
      380
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      132
    term
    ASTHENIA
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      380
    3. group Id
      EG002
      num Affected
      16
      num At Risk
      132
    term
    BACK PAIN
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      380
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      132
    term
    CHILLS
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      79
      num At Risk
      380
    3. group Id
      EG002
      num Affected
      34
      num At Risk
      132
    term
    CONSTIPATION
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      55
      num At Risk
      380
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      132
    term
    COUGH
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      380
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      132
    term
    ABDOMINAL DISTENSION
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      380
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      132
    term
    ABDOMINAL PAIN
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      380
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      132
    term
    ABDOMINAL PAIN UPPER
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      380
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      132
    term
    ABDOMINAL WALL MASS
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      380
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      132
    term
    ACCIDENTAL OVERDOSE
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      380
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      132
    term
    ACUTE HEPATIC FAILURE
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      380
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      132
    term
    ACUTE PULMONARY OEDEMA
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      380
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      132
    term
    ACUTE RESPIRATORY DISTRESS SYNDROME
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      380
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      132
    term
    ADRENAL INSUFFICIENCY
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      380
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      132
    term
    ADVERSE EVENT
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      380
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      132
    term
    ANAEMIA
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      380
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      132
    term
    ANGIOPATHY

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Preserved source evidence · Not medical advice