NCT01371643 · OUTCOME

Percentage of Responders (Primary Medical Treatment in Arm 1, Primary Surgical Treatment in Arm 2)

Surgical Debulking of Pituitary Adenomas · Source last updated 2016-08-29

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

Measure: NUMBER
Unit: percentage of participants
Interval / dispersion: 95% Confidence Interval
Time frame: 3 months

What was measured

Nadir growth hormone \<1 ng/mL during a standard 2 hour oral glucose tolerance test using 75 g glucose and normal IGF-I according to age and gender-matched standards.

Groups in this outcome

Medical Treatment by Octreotide LAR

Medical therapy with Octreotide LAR 30 mg/month for 3 months preceding surgery Octreotide LAR

Surgical Debulking Followed by Octreotide LAR

Surgical debulking of pituitary tumor followed by Octreotide LAR if not surgically cured Octreotide LAR transsphenoidal surgery

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

Analysis denominator · Participants

Group	Source count
Medical Treatment by Octreotide LAR	15
Surgical Debulking Followed by Octreotide LAR	26

Reported measurements

Source class 1

Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Medical Treatment by Octreotide LAR	6.7	Not reported	.2	31.9	Not reported
Surgical Debulking Followed by Octreotide LAR	50	Not reported	29.9	70.1	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
.2
upper Limit
31.9
value
6.7
group Id
OG001
lower Limit
29.9
upper Limit
70.1
value
50

denoms

counts
group Id
OG000
value
15
group Id
OG001
value
26
units
Participants

description

Nadir growth hormone \<1 ng/mL during a standard 2 hour oral glucose tolerance test using 75 g glucose and normal IGF-I according to age and gender-matched standards.

dispersion Type

95% Confidence Interval

groups

description
Medical therapy with Octreotide LAR 30 mg/month for 3 months preceding surgery Octreotide LAR
id
OG000
title
Medical Treatment by Octreotide LAR
description
Surgical debulking of pituitary tumor followed by Octreotide LAR if not surgically cured Octreotide LAR transsphenoidal surgery
id
OG001
title
Surgical Debulking Followed by Octreotide LAR

param Type

NUMBER

reporting Status

POSTED

time Frame

3 months

title

Percentage of Responders (Primary Medical Treatment in Arm 1, Primary Surgical Treatment in Arm 2)

type

PRIMARY

unit Of Measure

percentage of participants

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

Preserved source evidence · Not medical advice