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NCT00661999 · ADVERSE EVENTS

Adverse events

Darbepoetin Alfa With or Without Iron in Treating Anemia Caused By Chemotherapy in Patients With Cancer · Source last updated 2011-05-17

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
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
DA + IV Iron

Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.

5 / 164150 / 164Not reported / Not reported
DA + Oral Iron

Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.

3 / 163147 / 163Not reported / Not reported
DA + Placebo

Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.

2 / 163141 / 163Not reported / Not reported

Group identifiers: EG000: DA + IV Iron · EG001: DA + Oral Iron · EG002: DA + Placebo

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 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      164
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      163
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      163
      num Events
      0
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      164
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      163
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      163
      num Events
      1
    term
    Fistula-intestinal
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      164
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      163
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      163
      num Events
      1
    term
    Fatigue
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      164
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      163
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      163
      num Events
      0
    term
    Syndromes
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      164
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      163
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      163
      num Events
      0
    term
    Pneumonia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      164
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      163
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      163
      num Events
      0
    term
    Activated partial thromboplastin time prolonged
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      164
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      163
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      163
      num Events
      0
    term
    Leukopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      164
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      163
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      163
      num Events
      0
    term
    Neutropenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      164
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      163
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      163
      num Events
      0
    term
    Platelet count decreased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      164
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      163
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      163
      num Events
      0
    term
    Arthralgia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      164
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      163
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      163
      num Events
      0
    term
    Confusion
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      164
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      163
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      163
      num Events
      0
    term
    Dyspnea

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 6
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      164
      num Events
      9
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      163
      num Events
      14
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      163
      num Events
      9
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      164
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      163
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      163
      num Events
      4
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      164
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      163
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      163
      num Events
      1
    term
    Atrial fibrillation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      164
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      163
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      163
      num Events
      1
    term
    Ischemia/Infarction
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      164
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      163
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      163
      num Events
      0
    term
    Pericardial effusion
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      164
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      163
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      163
      num Events
      1
    term
    Restrictive cardiomyopathy
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      164
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      163
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      163
      num Events
      1
    term
    Right ventricular dysfunction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      164
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      163
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      163
      num Events
      0
    term
    Sinus tachycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      164
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      163
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      163
      num Events
      1
    term
    Supraventricular tachycardia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      164
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      163
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      163
      num Events
      1
    term
    Valvular heart disease
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      164
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      163
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      163
      num Events
      1
    term
    Extraocular muscle disorder
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      164
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      163
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      163
      num Events
      0
    term
    Ocular weakness
Complete source fields
event Groups
  1. description
    Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
    id
    EG000
    other Num Affected
    150
    other Num At Risk
    164
    serious Num Affected
    5
    serious Num At Risk
    164
    title
    DA + IV Iron
  2. description
    Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
    id
    EG001
    other Num Affected
    147
    other Num At Risk
    163
    serious Num Affected
    3
    serious Num At Risk
    163
    title
    DA + Oral Iron
  3. description
    Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
    id
    EG002
    other Num Affected
    141
    other Num At Risk
    163
    serious Num Affected
    2
    serious Num At Risk
    163
    title
    DA + Placebo
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      164
      num Events
      9
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      163
      num Events
      14
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      163
      num Events
      9
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      164
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      163
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      163
      num Events
      4
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      164
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      163
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      163
      num Events
      1
    term
    Atrial fibrillation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      164
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      163
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      163
      num Events
      1
    term
    Ischemia/Infarction
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      164
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      163
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      163
      num Events
      0
    term
    Pericardial effusion
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      164
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      163
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      163
      num Events
      1
    term
    Restrictive cardiomyopathy
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      164
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      163
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      163
      num Events
      1
    term
    Right ventricular dysfunction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      164
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      163
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      163
      num Events
      0
    term
    Sinus tachycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      164
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      163
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      163
      num Events
      1
    term
    Supraventricular tachycardia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      164
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      163
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      163
      num Events
      1
    term
    Valvular heart disease
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      164
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      163
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      163
      num Events
      1
    term
    Extraocular muscle disorder
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      164
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      163
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      163
      num Events
      0
    term
    Ocular weakness
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      164
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      163
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      163
      num Events
      0
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      164
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      163
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      163
      num Events
      1
    term
    Fistula-intestinal
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      164
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      163
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      163
      num Events
      1
    term
    Fatigue
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      164
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      163
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      163
      num Events
      0
    term
    Syndromes
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      164
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      163
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      163
      num Events
      0
    term
    Pneumonia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      164
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      163
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      163
      num Events
      0
    term
    Activated partial thromboplastin time prolonged
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      164
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      163
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      163
      num Events
      0
    term
    Leukopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      164
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      163
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      163
      num Events
      0
    term
    Neutropenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      164
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      163
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      163
      num Events
      0
    term
    Platelet count decreased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      164
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      163
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      163
      num Events
      0
    term
    Arthralgia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      164
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      163
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      163
      num Events
      0
    term
    Confusion
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      164
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      163
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      163
      num Events
      0
    term
    Dyspnea

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Preserved source evidence · Not medical advice