Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01677286 · ADVERSE EVENTS

Adverse events

Safety and Effect of Doxycycline in Patients With Amyloidosis · Source last updated 2017-08-01

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
Doxycycline 100 mg po Bid x 12 Months

Open-label doxycycline 100 mg twice daily by mouth was administered to subjects for 12 months, if tolerated.

12 / 2521 / 250 / 25

Group identifiers: EG000: Doxycycline 100 mg po Bid x 12 Months

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
    notes
    SOB, edema
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      25
      num Events
      4
    term
    Fluid overload
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Burns/desquamation induced by sun hypersensitivity
    organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Sun hypersensitivity
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Abdominal distension
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Bloating
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Urinary retention
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    osteonecrosis
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Surgical and medical procedures
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      25
      num Events
      2
    term
    Orthopedic issues
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Deep vein thrombosis
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Ventricular trachycardia
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Arrhythmia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      25
      num Events
      2
    term
    Hip disease
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Cytomegalovirus infection
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Skin cancer
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Hernia

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
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      25
      num Events
      21
    term
    Skin disruption
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      25
      num Events
      18
    term
    GI disorder
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      25
      num Events
      8
    term
    Infection
Complete source fields
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    25
    description
    Open-label doxycycline 100 mg twice daily by mouth was administered to subjects for 12 months, if tolerated.
    id
    EG000
    other Num Affected
    21
    other Num At Risk
    25
    serious Num Affected
    12
    serious Num At Risk
    25
    title
    Doxycycline 100 mg po Bid x 12 Months
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      25
      num Events
      21
    term
    Skin disruption
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      25
      num Events
      18
    term
    GI disorder
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      25
      num Events
      8
    term
    Infection
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    SOB, edema
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      25
      num Events
      4
    term
    Fluid overload
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Burns/desquamation induced by sun hypersensitivity
    organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Sun hypersensitivity
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Abdominal distension
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Bloating
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Urinary retention
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    osteonecrosis
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Surgical and medical procedures
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      25
      num Events
      2
    term
    Orthopedic issues
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Deep vein thrombosis
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Ventricular trachycardia
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Arrhythmia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      25
      num Events
      2
    term
    Hip disease
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Cytomegalovirus infection
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Skin cancer
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Hernia

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

Preserved source evidence · Not medical advice