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NCT01096810 · ADVERSE EVENTS

Adverse events

Study of TBL 12 Sea Cucumber Extract for Patients With Untreated Asymptomatic Myeloma · Source last updated 2016-07-22

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
TBL 12

TBL 12, sea cucumber, will be administered orally at a dose of 2 units (20 mL each) twice a day until disease progression

1 / 201 / 20Not reported / Not reported

Group identifiers: EG000: TBL 12

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. notes
    Pneumococcal pneumonia requiring admission, which was felt to be unrelated to study treatment
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Pneumococcal Pneumonia

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Nausea
Complete source fields
event Groups
  1. description
    TBL 12, sea cucumber, will be administered orally at a dose of 2 units (20 mL each) twice a day until disease progression
    id
    EG000
    other Num Affected
    1
    other Num At Risk
    20
    serious Num Affected
    1
    serious Num At Risk
    20
    title
    TBL 12
frequency Threshold
5
other Events
  1. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Nausea
serious Events
  1. notes
    Pneumococcal pneumonia requiring admission, which was felt to be unrelated to study treatment
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Pneumococcal Pneumonia

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

Preserved source evidence · Not medical advice