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NCT02919670 · ADVERSE EVENTS

Adverse events

A Study Evaluating a Proprietary Amino Acid Mixture (Enterade®) in Patients Receiving High-Dose Melphalan Conditioning Followed by Autologous Stem Cell Transplantation for Multiple Myeloma and Non-Hodgkin Lymphoma · Source last updated 2023-03-16

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
14 days
Other-event reporting threshold
0%

The primary endpoint is the incidence of NCI-CTCAE 4.0 grade 3 or higher GI toxicity in the 14 days following autologous HSCT

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Enterade and Standard Supportive Care

* Two 8 oz. bottles of Enterade will be administered daily * Enterade will be given orally from admission until day +14 or until discharge * Standard Supportive Care will be administered according to institution's practice Enterade Standard Supportive Care

0 / 4918 / 490 / 49
Placebo and Standard Supportive Care

* Two 8 oz. bottles of Placebo will be administered daily * Placebo will be given orally from admission until day +14 or until discharge * Standard Supportive Care will be administered according to institution's practice Placebo Standard Supportive Care

1 / 5021 / 501 / 50

Group identifiers: EG000: Enterade and Standard Supportive Care · EG001: Placebo and Standard Supportive Care

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
    Infections and infestations
    stats
    1. group Id
      EG000
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      50
    term
    Clostridium septicum septic shock

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
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      50
    term
    Colitis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      50
    term
    Diarrhea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      50
    term
    Dysphagia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      50
    term
    Esophagitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      50
    term
    Mucositis oral
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      50
    term
    Nausea
Complete source fields
description
The primary endpoint is the incidence of NCI-CTCAE 4.0 grade 3 or higher GI toxicity in the 14 days following autologous HSCT
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    49
    description
    * Two 8 oz. bottles of Enterade will be administered daily * Enterade will be given orally from admission until day +14 or until discharge * Standard Supportive Care will be administered according to institution's practice Enterade Standard Supportive Care
    id
    EG000
    other Num Affected
    18
    other Num At Risk
    49
    serious Num Affected
    0
    serious Num At Risk
    49
    title
    Enterade and Standard Supportive Care
  2. deaths Num Affected
    1
    deaths Num At Risk
    50
    description
    * Two 8 oz. bottles of Placebo will be administered daily * Placebo will be given orally from admission until day +14 or until discharge * Standard Supportive Care will be administered according to institution's practice Placebo Standard Supportive Care
    id
    EG001
    other Num Affected
    21
    other Num At Risk
    50
    serious Num Affected
    1
    serious Num At Risk
    50
    title
    Placebo and Standard Supportive Care
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      50
    term
    Colitis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      50
    term
    Diarrhea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      50
    term
    Dysphagia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      50
    term
    Esophagitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      50
    term
    Mucositis oral
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      50
    term
    Nausea
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      50
    term
    Clostridium septicum septic shock
time Frame
14 days

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Preserved source evidence · Not medical advice