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Table 6 Chronological listing of withdrawals

From: Study of Optimal Replacement of Thyroxine in the Elderly (SORTED) – results from the feasibility randomised controlled trial

Subject ID Treatment allocation Randomisation date Withdrawal date Days in the study Reason (severity and relation to study drug)
709 Reduced dose 07/12/2012 09/01/2013 34 Withdrew due to AEs experienced whilst on the study: constipation, tiredness and generally unwell (mild, possibly related)
103 Usual dose 11/01/2013 23/01/2013 13 Withdrew due to “feeling unwell” (mild, possibly related)
104 Reduced dose 11/01/2013 27/03/2013 76 Withdrew due to infected right foot (moderate, not related), loose stools (moderate, unknown relationship to study drug) and sore wrist (mild, unknown relationship to study drug)
509 Reduced dose 26/11/2012 22/04/2013 148 6 weeks after Visit 2 withdrew from the study due to tiredness (moderate, possibly related)
205 Usual dose 01/03/2013 22/04/2013 53 Withdrew due to fatigue which started 2 weeks after commencing the study drug. The patient was hospitalised with a mild stroke on 22/04/13, reported to be linked to ongoing hypertension (severe, not related).
515 Reduced dose 18/02/2013 08/05/2013 80 Withdrew after experiencing several AEs: dry skin, dry hair, feeling cold, weight gain and tiredness (mild, possibly related), and swollen face with itching (mild, not related) - unscheduled home visit: thyroid function normal, weight gain of 0.3kgs.
521 Reduced dose 15/05/2013 12/06/2013 29 Withdrew after experiencing several AEs: nausea and loss of appetite (mild, not related), vertigo (mild, not related) and confusion (mild, not related)
614 Usual dose 20/03/2013 27/06/2013 100 At Visit 2 patient reported that she had been taking her prescribed dose of LT4 as well as the study medication. Patient reported no AEs. Serum thyroid function was normal (TSH 0.60, FT4 20.8). Subsequently the patient changed her mind and withdrew.
  1. AEs adverse events, LT4 levothyroxine