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NCT00580788 · ADVERSE EVENTS

Adverse events

One Week Parathyroid Hormone-related Protein (PTHrP) IV Dose Escalation Study · Source last updated 2016-02-11

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
Subjects were systematically assessed every 8 hours for adverse events
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Group 1

PTHrP(1-36) 2 picomoles/kg/hr for one week.

0 / 30 / 3Not reported / Not reported
Group 2

PTHrP(1-36) 4 picomoles/kg/hr for one week.

0 / 60 / 6Not reported / Not reported
Group 3

PTHrP(1-36) 5 picomoles/kg/hr for one week.

0 / 31 / 3Not reported / Not reported
Group 4

PTHrP(1-36) 6 picomoles/kg/hr for one week.

0 / 22 / 2Not reported / Not reported

Group identifiers: EG000: Group 1 · EG001: Group 2 · EG002: Group 3 · EG003: Group 4

Serious adverse events

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

    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
      Endocrine disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        3
        num Events
        0
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        6
        num Events
        0
      3. group Id
        EG002
        num Affected
        1
        num At Risk
        3
        num Events
        1
      4. group Id
        EG003
        num Affected
        1
        num At Risk
        2
        num Events
        1
      term
      hypercalcemia
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Endocrine disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        3
        num Events
        0
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        6
        num Events
        0
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        3
        num Events
        0
      4. group Id
        EG003
        num Affected
        1
        num At Risk
        2
        num Events
        1
      term
      hypertension
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Endocrine disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        3
        num Events
        0
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        6
        num Events
        0
      3. group Id
        EG002
        num Affected
        1
        num At Risk
        3
        num Events
        1
      4. group Id
        EG003
        num Affected
        0
        num At Risk
        2
        num Events
        0
      term
      migraine
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Endocrine disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        3
        num Events
        0
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        6
        num Events
        0
      3. group Id
        EG002
        num Affected
        1
        num At Risk
        3
        num Events
        1
      4. group Id
        EG003
        num Affected
        0
        num At Risk
        2
        num Events
        0
      term
      lightheaded
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Endocrine disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        3
        num Events
        0
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        6
        num Events
        0
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        3
        num Events
        0
      4. group Id
        EG003
        num Affected
        1
        num At Risk
        2
        num Events
        1
      term
      tachycardia
    Complete source fields
    event Groups
    1. description
      PTHrP(1-36) 2 picomoles/kg/hr for one week.
      id
      EG000
      other Num Affected
      0
      other Num At Risk
      3
      serious Num Affected
      0
      serious Num At Risk
      3
      title
      Group 1
    2. description
      PTHrP(1-36) 4 picomoles/kg/hr for one week.
      id
      EG001
      other Num Affected
      0
      other Num At Risk
      6
      serious Num Affected
      0
      serious Num At Risk
      6
      title
      Group 2
    3. description
      PTHrP(1-36) 5 picomoles/kg/hr for one week.
      id
      EG002
      other Num Affected
      1
      other Num At Risk
      3
      serious Num Affected
      0
      serious Num At Risk
      3
      title
      Group 3
    4. description
      PTHrP(1-36) 6 picomoles/kg/hr for one week.
      id
      EG003
      other Num Affected
      2
      other Num At Risk
      2
      serious Num Affected
      0
      serious Num At Risk
      2
      title
      Group 4
    frequency Threshold
    0
    other Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Endocrine disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        3
        num Events
        0
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        6
        num Events
        0
      3. group Id
        EG002
        num Affected
        1
        num At Risk
        3
        num Events
        1
      4. group Id
        EG003
        num Affected
        1
        num At Risk
        2
        num Events
        1
      term
      hypercalcemia
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Endocrine disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        3
        num Events
        0
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        6
        num Events
        0
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        3
        num Events
        0
      4. group Id
        EG003
        num Affected
        1
        num At Risk
        2
        num Events
        1
      term
      hypertension
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Endocrine disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        3
        num Events
        0
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        6
        num Events
        0
      3. group Id
        EG002
        num Affected
        1
        num At Risk
        3
        num Events
        1
      4. group Id
        EG003
        num Affected
        0
        num At Risk
        2
        num Events
        0
      term
      migraine
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Endocrine disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        3
        num Events
        0
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        6
        num Events
        0
      3. group Id
        EG002
        num Affected
        1
        num At Risk
        3
        num Events
        1
      4. group Id
        EG003
        num Affected
        0
        num At Risk
        2
        num Events
        0
      term
      lightheaded
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Endocrine disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        3
        num Events
        0
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        6
        num Events
        0
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        3
        num Events
        0
      4. group Id
        EG003
        num Affected
        1
        num At Risk
        2
        num Events
        1
      term
      tachycardia
    time Frame
    Subjects were systematically assessed every 8 hours for adverse events

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

    Preserved source evidence · Not medical advice