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NCT00262847 · ADVERSE EVENTS

Adverse events

Carboplatin and Paclitaxel With or Without Bevacizumab in Treating Patients With Stage III or Stage IV Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer · Source last updated 2019-07-23

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
All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adeverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm I (Placebo, Paclitaxel, Carboplatin)

Control therapy: Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus placebo (starting in cycle 2) every 3 weeks. Cycles 7-22 received placebo every 3 weeks.

239 / 621589 / 621Not reported / Not reported
Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab)

Bevacizumab-initiation therapy: Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks. Cycles 7-22 received placebo every 3 weeks.

257 / 624593 / 624Not reported / Not reported
Arm III (Paclitaxel, Carboplatin, Bevacizumab)

Bevacizumab-throughout therapy: Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks. Cycles 7-22 received bevacizumab, 15 mg/kg every 3 weeks.

287 / 619588 / 619Not reported / Not reported

Group identifiers: EG000: Arm I (Placebo, Paclitaxel, Carboplatin) · EG001: Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab) · EG002: Arm III (Paclitaxel, Carboplatin, Bevacizumab)

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
    Immune system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      621
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      624
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      619
    term
    Allergy/Immunology - Other
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      621
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      624
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      619
    term
    Allergic Reaction/Hypersensitivity
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      621
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      624
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      619
    term
    Myelodysplasia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      621
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      624
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      619
    term
    Neutrophils
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      621
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      624
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      619
    term
    Platelets
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      621
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      624
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      619
    term
    Leukocytes
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      621
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      624
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      619
    term
    Hemoglobin
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      621
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      624
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      619
    term
    S/N Arrhythmia: Atrial Fibrillation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      621
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      624
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      619
    term
    Cardiac Arrhythmia - Other
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      621
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      624
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      619
    term
    S/N Arrhythmia: Atrial Flutter
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      621
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      624
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      619
    term
    Vasovagal Episode
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      621
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      624
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      619
    term
    Supraventricular Tachycardia

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
    Immune system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      56
      num At Risk
      621
    2. group Id
      EG001
      num Affected
      65
      num At Risk
      624
    3. group Id
      EG002
      num Affected
      68
      num At Risk
      619
    term
    Allergic Reaction/Hypersensitivity
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      67
      num At Risk
      621
    2. group Id
      EG001
      num Affected
      93
      num At Risk
      624
    3. group Id
      EG002
      num Affected
      98
      num At Risk
      619
    term
    Rhinitis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      621
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      624
    3. group Id
      EG002
      num Affected
      32
      num At Risk
      619
    term
    Tinnitus
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      589
      num At Risk
      621
    2. group Id
      EG001
      num Affected
      591
      num At Risk
      624
    3. group Id
      EG002
      num Affected
      588
      num At Risk
      619
    term
    Neutrophils
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      419
      num At Risk
      621
    2. group Id
      EG001
      num Affected
      426
      num At Risk
      624
    3. group Id
      EG002
      num Affected
      435
      num At Risk
      619
    term
    Platelets
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      578
      num At Risk
      621
    2. group Id
      EG001
      num Affected
      593
      num At Risk
      624
    3. group Id
      EG002
      num Affected
      586
      num At Risk
      619
    term
    Leukocytes
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      621
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      624
    3. group Id
      EG002
      num Affected
      32
      num At Risk
      619
    term
    Lymphopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      587
      num At Risk
      621
    2. group Id
      EG001
      num Affected
      574
      num At Risk
      624
    3. group Id
      EG002
      num Affected
      572
      num At Risk
      619
    term
    Hemoglobin
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      621
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      624
    3. group Id
      EG002
      num Affected
      30
      num At Risk
      619
    term
    Palpitations
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      90
      num At Risk
      621
    2. group Id
      EG001
      num Affected
      149
      num At Risk
      624
    3. group Id
      EG002
      num Affected
      206
      num At Risk
      619
    term
    Hypertension
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      621
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      624
    3. group Id
      EG002
      num Affected
      33
      num At Risk
      619
    term
    Hypotension
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      621
    2. group Id
      EG001
      num Affected
      37
      num At Risk
      624
    3. group Id
      EG002
      num Affected
      31
      num At Risk
      619
    term
    Sweating
Complete source fields
event Groups
  1. description
    Control therapy: Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus placebo (starting in cycle 2) every 3 weeks. Cycles 7-22 received placebo every 3 weeks.
    id
    EG000
    other Num Affected
    589
    other Num At Risk
    621
    serious Num Affected
    239
    serious Num At Risk
    621
    title
    Arm I (Placebo, Paclitaxel, Carboplatin)
  2. description
    Bevacizumab-initiation therapy: Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks. Cycles 7-22 received placebo every 3 weeks.
    id
    EG001
    other Num Affected
    593
    other Num At Risk
    624
    serious Num Affected
    257
    serious Num At Risk
    624
    title
    Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab)
  3. description
    Bevacizumab-throughout therapy: Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks. Cycles 7-22 received bevacizumab, 15 mg/kg every 3 weeks.
    id
    EG002
    other Num Affected
    588
    other Num At Risk
    619
    serious Num Affected
    287
    serious Num At Risk
    619
    title
    Arm III (Paclitaxel, Carboplatin, Bevacizumab)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      56
      num At Risk
      621
    2. group Id
      EG001
      num Affected
      65
      num At Risk
      624
    3. group Id
      EG002
      num Affected
      68
      num At Risk
      619
    term
    Allergic Reaction/Hypersensitivity
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      67
      num At Risk
      621
    2. group Id
      EG001
      num Affected
      93
      num At Risk
      624
    3. group Id
      EG002
      num Affected
      98
      num At Risk
      619
    term
    Rhinitis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      621
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      624
    3. group Id
      EG002
      num Affected
      32
      num At Risk
      619
    term
    Tinnitus
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      589
      num At Risk
      621
    2. group Id
      EG001
      num Affected
      591
      num At Risk
      624
    3. group Id
      EG002
      num Affected
      588
      num At Risk
      619
    term
    Neutrophils
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      419
      num At Risk
      621
    2. group Id
      EG001
      num Affected
      426
      num At Risk
      624
    3. group Id
      EG002
      num Affected
      435
      num At Risk
      619
    term
    Platelets
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      578
      num At Risk
      621
    2. group Id
      EG001
      num Affected
      593
      num At Risk
      624
    3. group Id
      EG002
      num Affected
      586
      num At Risk
      619
    term
    Leukocytes
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      621
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      624
    3. group Id
      EG002
      num Affected
      32
      num At Risk
      619
    term
    Lymphopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      587
      num At Risk
      621
    2. group Id
      EG001
      num Affected
      574
      num At Risk
      624
    3. group Id
      EG002
      num Affected
      572
      num At Risk
      619
    term
    Hemoglobin
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      621
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      624
    3. group Id
      EG002
      num Affected
      30
      num At Risk
      619
    term
    Palpitations
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      90
      num At Risk
      621
    2. group Id
      EG001
      num Affected
      149
      num At Risk
      624
    3. group Id
      EG002
      num Affected
      206
      num At Risk
      619
    term
    Hypertension
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      621
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      624
    3. group Id
      EG002
      num Affected
      33
      num At Risk
      619
    term
    Hypotension
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      621
    2. group Id
      EG001
      num Affected
      37
      num At Risk
      624
    3. group Id
      EG002
      num Affected
      31
      num At Risk
      619
    term
    Sweating
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      621
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      624
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      619
    term
    Allergy/Immunology - Other
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      621
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      624
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      619
    term
    Allergic Reaction/Hypersensitivity
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      621
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      624
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      619
    term
    Myelodysplasia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      621
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      624
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      619
    term
    Neutrophils
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      621
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      624
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      619
    term
    Platelets
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      621
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      624
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      619
    term
    Leukocytes
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      621
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      624
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      619
    term
    Hemoglobin
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      621
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      624
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      619
    term
    S/N Arrhythmia: Atrial Fibrillation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      621
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      624
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      619
    term
    Cardiac Arrhythmia - Other
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      621
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      624
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      619
    term
    S/N Arrhythmia: Atrial Flutter
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      621
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      624
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      619
    term
    Vasovagal Episode
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      621
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      624
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      619
    term
    Supraventricular Tachycardia
time Frame
All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adeverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.

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Preserved source evidence · Not medical advice