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NCT01160380 · ADVERSE EVENTS

Adverse events

A Study of the Effectiveness of Armodafinil to Treat Cancer-Related Fatigue in Patients With Multiple Myeloma · Source last updated 2014-11-06

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
8 weeks
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Armodafinil

The patients receive armodafinil for all 56 days of the study. Armodafinil taken orally at 150 mg daily. All patients receiving armodafinil, including patients that crossover, were evaluated for adverse events (AEs) and serious adverse events (SAEs).

2 / 5015 / 50Not reported / Not reported
Placebo-First

These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56). Placebo taken orally at 150 mg daily. Armodafinil taken orally at 150 mg daily. AEs presented were those occurring during from Day 1 to Day 28 only

0 / 252 / 25Not reported / Not reported

Group identifiers: EG000: Armodafinil · EG001: Placebo-First

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
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      50
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    term
    Pneumonia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      50
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    term
    Ptosis

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
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      50
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    G3/G4 Leukopenia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      50
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    G3/G4 Lymphopenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      50
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    term
    G3/G4 Neutropenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      50
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    term
    G3/G4 BUN (increased)
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      50
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    term
    G3/G4 Creatinine (increased)
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      50
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    term
    G4 Edema
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      50
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    term
    G3/G4 Eosinophils (increased)
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      50
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    term
    G3/G4 Hypokalemia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      50
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    term
    G3/G4 Infection (ear)
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      50
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    term
    G3/G4 Neuroma
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      50
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    term
    G3/G4 Upper Respiratory Infection
Complete source fields
event Groups
  1. description
    The patients receive armodafinil for all 56 days of the study. Armodafinil taken orally at 150 mg daily. All patients receiving armodafinil, including patients that crossover, were evaluated for adverse events (AEs) and serious adverse events (SAEs).
    id
    EG000
    other Num Affected
    15
    other Num At Risk
    50
    serious Num Affected
    2
    serious Num At Risk
    50
    title
    Armodafinil
  2. description
    These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56). Placebo taken orally at 150 mg daily. Armodafinil taken orally at 150 mg daily. AEs presented were those occurring during from Day 1 to Day 28 only
    id
    EG001
    other Num Affected
    2
    other Num At Risk
    25
    serious Num Affected
    0
    serious Num At Risk
    25
    title
    Placebo-First
frequency Threshold
0
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      50
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    G3/G4 Leukopenia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      50
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    G3/G4 Lymphopenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      50
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    term
    G3/G4 Neutropenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      50
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    term
    G3/G4 BUN (increased)
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      50
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    term
    G3/G4 Creatinine (increased)
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      50
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    term
    G4 Edema
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      50
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    term
    G3/G4 Eosinophils (increased)
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      50
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    term
    G3/G4 Hypokalemia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      50
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    term
    G3/G4 Infection (ear)
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      50
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    term
    G3/G4 Neuroma
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      50
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    term
    G3/G4 Upper Respiratory Infection
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      50
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    term
    Pneumonia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      50
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    term
    Ptosis
time Frame
8 weeks

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice