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NCT02078102 · ADVERSE EVENTS

Adverse events

A Phase II Trial Using Meloxicam Plus Filgrastim in Patients With Multiple Myeloma and Non-Hodgkin's Lymphoma · Source last updated 2021-02-21

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
up to 100 days post-transplant
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Multiple Myeloma

This is for the patients with Multiple Myeloma. Meloxicam and Filgrastim will be administered in fixed doses to each patient enrolled on this study. The treatments will be administered in a staggered dose schedule for a total treatment duration of 7 days prior to apheresis. 15 mg tablets of Meloxicam will be taken orally for 5 consecutive days. 10 µg/kg of Filgrastim will be subcutaneously injected for 5 consecutive days. Filgrastim may be subcutaneously injected for an additional 3 days if patients do not meet the primary endpoint for cell collection. Meloxicam: 15 mg tablets of Meloxicam will be taken orally in the morning, with or without food. Filgrastim: Filgrastim will be subcutaneously injected in one or two sites at home.

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Non Hodgkins Lymphoma

This is for the patients with Non Hodgkins Lymphoma. Meloxicam and Filgrastim will be administered in fixed doses to each patient enrolled on this study. The treatments will be administered in a staggered dose schedule for a total treatment duration of 7 days prior to apheresis. 15 mg tablets of Meloxicam will be taken orally for 5 consecutive days. 10 µg/kg of Filgrastim will be subcutaneously injected for 5 consecutive days. Filgrastim may be subcutaneously injected for an additional 3 days if patients do not meet the primary endpoint for cell collection. Meloxicam: 15 mg tablets of Meloxicam will be taken orally in the morning, with or without food. Filgrastim: Filgrastim will be subcutaneously injected in one or two sites at home.

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Group identifiers: EG000: Multiple Myeloma · EG001: Non Hodgkins Lymphoma

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    term
    Diarrhea
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      25
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      25
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      13
    term
    Anemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    Chest pain - cardiac
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      25
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      13
    term
    Abdominal pain
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      25
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      13
    term
    Nausea
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      25
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    Oral dysesthesia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    Fatigue
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      13
    term
    Pain
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      25
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    Skin infection
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      25
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    term
    Upper respiratory infection
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      13
    term
    Platelet count decreased
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      13
    term
    Hypocalcemia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      25
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    Hypokalemia
Complete source fields
event Groups
  1. deaths Num Affected
    4
    deaths Num At Risk
    25
    description
    This is for the patients with Multiple Myeloma. Meloxicam and Filgrastim will be administered in fixed doses to each patient enrolled on this study. The treatments will be administered in a staggered dose schedule for a total treatment duration of 7 days prior to apheresis. 15 mg tablets of Meloxicam will be taken orally for 5 consecutive days. 10 µg/kg of Filgrastim will be subcutaneously injected for 5 consecutive days. Filgrastim may be subcutaneously injected for an additional 3 days if patients do not meet the primary endpoint for cell collection. Meloxicam: 15 mg tablets of Meloxicam will be taken orally in the morning, with or without food. Filgrastim: Filgrastim will be subcutaneously injected in one or two sites at home.
    id
    EG000
    other Num Affected
    10
    other Num At Risk
    25
    serious Num Affected
    1
    serious Num At Risk
    25
    title
    Multiple Myeloma
  2. deaths Num Affected
    1
    deaths Num At Risk
    13
    description
    This is for the patients with Non Hodgkins Lymphoma. Meloxicam and Filgrastim will be administered in fixed doses to each patient enrolled on this study. The treatments will be administered in a staggered dose schedule for a total treatment duration of 7 days prior to apheresis. 15 mg tablets of Meloxicam will be taken orally for 5 consecutive days. 10 µg/kg of Filgrastim will be subcutaneously injected for 5 consecutive days. Filgrastim may be subcutaneously injected for an additional 3 days if patients do not meet the primary endpoint for cell collection. Meloxicam: 15 mg tablets of Meloxicam will be taken orally in the morning, with or without food. Filgrastim: Filgrastim will be subcutaneously injected in one or two sites at home.
    id
    EG001
    other Num Affected
    10
    other Num At Risk
    13
    serious Num Affected
    1
    serious Num At Risk
    13
    title
    Non Hodgkins Lymphoma
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      25
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      13
    term
    Anemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    Chest pain - cardiac
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      25
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      13
    term
    Abdominal pain
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      25
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      13
    term
    Nausea
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      25
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    Oral dysesthesia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    Fatigue
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      13
    term
    Pain
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      25
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    Skin infection
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      25
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    term
    Upper respiratory infection
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      13
    term
    Platelet count decreased
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      13
    term
    Hypocalcemia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      25
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    Hypokalemia
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    term
    Diarrhea
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      25
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    Dyspnea
time Frame
up to 100 days post-transplant

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Preserved source evidence · Not medical advice