Study ID | |
Albino 2010 | Endpoints quoted in trial document(s) (ClinicalTrials.gov, FDA/EMA document, manufacturer's website, published design paper)a,c |
Source: NT | |
Endpoints quoted in publication(s)b,c | |
Primary outcome measure(s): — Secondary outcome measure(s): — Other outcome measure(s): thyroid volume, tracheal compression (tracheal cross‐sectional area), antithyroid antibodies, and thyroid hormones, hypothyroidism | |
Endpoints quoted in abstract of publication(s)b,c | |
Primary outcome measure(s): — Secondary outcome measure(s): — Other outcome measure(s): thyroid function tests, TSH receptor antibodies, thyroid peroxidase antibodies (TPOAb), antithyroglobulin antibodies, thyroid volume, tracheal compression, adverse effects (clinical assessment and frequent measures of thyroid hormone levels) | |
Bonnema 2007 | Endpoints quoted in trial document(s) (ClinicalTrials.gov, FDA/EMA document, manufacturer's website, published design paper)a,c |
Source: NT | |
Endpoints quoted in publication(s)b,c | |
Primary outcome measure(s): 1. Permanent hypothyroid 2. Adverse effects related to thyroid pain and cervical compression Secondary outcome measure(s): 1. Goitre volume reduction Other outcome measure(s): thyroid function tests, TSH receptor antibodies, thyroid peroxidase antibodies (TPOAb), antithyroglobulin antibodies, patient satisfaction | |
Endpoints quoted in abstract of publication(s)b,c | |
Primary outcome measure(s): 1. Adverse effects related to thyroid pain and cervical compression 2. Hypothyroidism Secondary outcome measure(s): 1. Goitre volume reduction Other outcome measure(s): thyroid function tests, TSH receptor antibodies, thyroid peroxidase antibodies (TPOAb), antithyroglobulin antibodies, thyroid volume, tracheal compression, adverse effects (clinical assessment and frequent measures of thyroid hormone levels) | |
Cubas 2009 | Endpoints quoted in trial document(s) (ClinicalTrials.gov, FDA/EMA document, manufacturer's website, published design paper)a,c |
Source: NT | |
Endpoints quoted in publication(s)b,c | |
Primary outcome measure(s): 1. Hypothyroidism 2. Adverse events related to radioiodine treatment Secondary outcome measure(s): 1. Thyroid volume reduction Other outcome measure(s): thyroid function tests, thyroglobulin, thyroid volume, adverse effects (clinical assessment and frequent measures of thyroid hormone levels), all cause mortality | |
Endpoints quoted in abstract of publication(s)b,c | |
Primary outcome measure(s): 1. Hypothyroidism 2. Hyperthyroidism related to radioiodine treatment Secondary outcome measure(s): 1. Thyroid volume reduction Other outcome measure(s): thyroid function tests, thyroglobulin, thyroid volume, adverse effects (clinical assessment and frequent measures of thyroid hormone levels), all cause mortality | |
Fast 2010 | Endpoints quoted in trial document(s) (ClinicalTrials.gov, FDA/EMA document, manufacturer's website, published design paper)a,c |
Source:NCT00275171 Primary outcome measure(s):
Secondary outcome measure(s):
Other outcome measure(s): — Trial results available in trial register: no | |
Endpoints quoted in publication(s)b,c | |
Primary outcome measure(s): — Secondary outcome measure(s): — Other outcome measure(s): goitre volume reduction, hospitalisation, goitre‐related symptoms, thyroid function tests, thyroid peroxidase antibodies, TSH receptor antibodies, thyroid size, patient satisfaction (visual analogue scale) | |
Endpoints quoted in abstract of publication(s)b,c | |
Primary outcome measure(s): — Secondary outcome measure(s): — Other outcome measure(s): goitre volume reduction, hospitalisation (according to the official radiation regulation), goitre‐related symptoms, prevalence of myxoedema | |
Fast 2014 | Endpoints quoted in trial document(s) (ClinicalTrials.gov, FDA/EMA document, manufacturer's website, published design paper)a,c |
Source: NT | |
Endpoints quoted in publication(s)b,c | |
Primary outcome measure(s): 1. The ThyQoL questionnaire contained17 goitre‐specific items and several overall quality‐of life items before and after stimulation with rhTSH or placebo 2. Thyroid function was monitored every three months, until 36 months. Antibodies against the TSH receptor were measured at baseline and repeated at six months 3. Adverse events were continuously monitored, and were coded using the Medical Dictionary for Regulatory Activities (MedDRA) v10.0 or higher Secondary outcome measure(s): 1. Thyroid volume was monitored by computed tomography (CT) scan of the neck, and performed at baseline, six months, and 36 months following therapy Other outcome measure(s): thyroid antithyroid antibodies, cross‐sectional area of trachea | |
Endpoints quoted in abstract of publication(s)b,c | |
Primary outcome measure(s): 1. The quality of life was improved 2. Permanent hypothyroidism at 3 years Secondary outcome measure(s): 1. Thyroid volume reduction at 6 mo and 36 mo Other outcome measure(s): radioiodine uptake, cross‐sectional area of trachea | |
Nielsen 2006 | Endpoints quoted in trial document(s) (ClinicalTrials.gov, FDA/EMA document, manufacturer's website, published design paper)a,c |
Source:NCT00145366 Primary outcome measure(s): 1. Permanent hypothyroidism after treatment 2. Adverse effects related to hyperthyroid Secondary outcome measure(s): 1. Goitre volume reduction Other outcome measure(s): TSH receptor antibodies, thyroid peroxidase antibodies (TPOAb), antithyroglobulin antibodies, patient satisfaction Trial results available in trial register: no | |
Endpoints quoted in publication(s)b,c | |
Primary outcome measure(s): 1. Permanent hypothyroidism after treatment 2. Adverse effects related to hyperthyroid Secondary outcome measure(s): 1. Goitre volume reduction Other outcome measure(s): patient satisfaction | |
Endpoints quoted in abstract of publication(s)b,c | |
Primary outcome measure(s): — Secondary outcome measure(s): — Other outcome measure(s): — | |
— denotes not reported
aTrial document(s) refers to all available information from published design papers and sources other than regular publications (e.g. FDA/EMA documents, manufacturer's websites, trial registers).
bPublication(s) refers to trial information published in scientific journals (primary reference, duplicate publications, companion documents, or multiple reports of a primary trial).
cPrimary and secondary outcomes refer to verbatim specifications in publication/records. Unspecified outcome measures refer to all outcomes not described as primary or secondary outcome measures. EMA: European Medicines Agency; FDA: Food and Drug Administration (US); NT: no trial document available. |