Table 6 Chronological listing of withdrawals
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. |