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NCT02299089 · OUTCOME

Number of Adverse Events and Serious Adverse Events

Phase II Study of Subcutaneous Inj. Depot of Octreotide in Patients With Acromegaly and Neuroendocrine Tumours (NETs) · Source last updated 2017-12-15

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Day -28 to Day 84

What was measured

Safety (number of adverse events and serious adverse events) after repeated doses of CAM2029 (assessment period from Day 0 to Day 84) and single dose Sandostatin LAR (assessment period Day -28 to Day 0)

Analysis population: Safety population (n=12). Patients treated with Sandostatin LAR Day -28 to 0 and CAM2029 (Day 0 to Day 84)

Groups in this outcome

CAM2029 10 mg q2w (Acromegaly)

CAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks octreotide FluidCrystal® injection depot

CAM2029 20 mg q4w (Acromegaly)

CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly octreotide FluidCrystal® injection depot

CAM2029 10 mg q2w (NET)

CAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks octreotide FluidCrystal® injection depot

CAM2029 20 mg q4w (NET)

CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly octreotide FluidCrystal® injection depot

Sandostatin LAR (Acromegaly)

Period day -28 to day 0 All acromegaly patients and all treatment groups

Sandostain LAR (NET)

Period day-28 to 0 All NET patient and all treatment groups

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
CAM2029 10 mg q2w (Acromegaly)3
CAM2029 20 mg q4w (Acromegaly)4
CAM2029 10 mg q2w (NET)1
CAM2029 20 mg q4w (NET)4
Sandostatin LAR (Acromegaly)7
Sandostain LAR (NET)5

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CAM2029 10 mg q2w (Acromegaly)2Not reportedNot reportedNot reportedNot reported
CAM2029 20 mg q4w (Acromegaly)4Not reportedNot reportedNot reportedNot reported
CAM2029 10 mg q2w (NET)0Not reportedNot reportedNot reportedNot reported
CAM2029 20 mg q4w (NET)2Not reportedNot reportedNot reportedNot reported
Sandostatin LAR (Acromegaly)4Not reportedNot reportedNot reportedNot reported
Sandostain LAR (NET)2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        2
      5. group Id
        OG004
        value
        4
      6. group Id
        OG005
        value
        2
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      4
    3. group Id
      OG002
      value
      1
    4. group Id
      OG003
      value
      4
    5. group Id
      OG004
      value
      7
    6. group Id
      OG005
      value
      5
    units
    Participants
description
Safety (number of adverse events and serious adverse events) after repeated doses of CAM2029 (assessment period from Day 0 to Day 84) and single dose Sandostatin LAR (assessment period Day -28 to Day 0)
groups
  1. description
    CAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks octreotide FluidCrystal® injection depot
    id
    OG000
    title
    CAM2029 10 mg q2w (Acromegaly)
  2. description
    CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly octreotide FluidCrystal® injection depot
    id
    OG001
    title
    CAM2029 20 mg q4w (Acromegaly)
  3. description
    CAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks octreotide FluidCrystal® injection depot
    id
    OG002
    title
    CAM2029 10 mg q2w (NET)
  4. description
    CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly octreotide FluidCrystal® injection depot
    id
    OG003
    title
    CAM2029 20 mg q4w (NET)
  5. description
    Period day -28 to day 0 All acromegaly patients and all treatment groups
    id
    OG004
    title
    Sandostatin LAR (Acromegaly)
  6. description
    Period day-28 to 0 All NET patient and all treatment groups
    id
    OG005
    title
    Sandostain LAR (NET)
param Type
COUNT_OF_PARTICIPANTS
population Description
Safety population (n=12). Patients treated with Sandostatin LAR Day -28 to 0 and CAM2029 (Day 0 to Day 84)
reporting Status
POSTED
time Frame
Day -28 to Day 84
title
Number of Adverse Events and Serious Adverse Events
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice