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Exercise on Adverse Event Monitoring
Which of the following are adverse
events?
Which are serious
adverse events?
1. A 68 year old female
patient was receiving oral lamotrigine 50mg, once daily, for biopolar
disorder. During the study she was admitted to hospital as her family
could not cope with her at home. She continued in the study. The
investigator considered the event was unrelated to use of lamotrigine.
2. A 22 year old female
patient was receiving oral naratriptan 2.5mg, as required, for treatment
of migraine. At study entry she was scheduled to undergo a tonsillectomy.
During the study she experienced intermittent tonsillitis which
necessitated the date of her tonsillectomy to be brought forward.
The operation proceeded uneventfully and the patient made a good
recovery. The investigator considered the tonsillitis was unrelated
to the use of study medication.
3. A 28 year old male
patient was receiving oral lamivudine 150mg, twice daily, for treatment
of HIV infection. Concurrent medication included AZT. After five
months in the study routine blood sampling revealed anaemia with
a haemoglobin level of 8.2g/dL. The patient was admitted to hospital
for a blood transfusion. The investigator considered the event was
possibly related to the use of study medication.
4. A 70 year old male
patient was receiving salmeterol. He developed a headache and dizziness
and was kept in hospital for 24 hours for observation. He was discharged
and his condition had resolved completely. The investigator considered
the event was probably related to the study drug.
5. A 22 year old male
patient injured his knee whilst playing football in October 1995.
He was entered onto a valaciclovir study in December 1995. In February
1996 the patient elected to undergo surgery on his knee even though
his condition had not worsened. He was hospitalised for two days
and the pain in his knee resolved two days later.
6. At baseline a patient states that she
experienced pain and swelling in her fingers about once each month
which improves when she takes a non-steroidal anti-inflammatory
drug (NSAID). After study drug administration, she states that the
pain and swelling are occurring weekly and that she no longer gets
relief from the NSAID. The investigator considers this to be unrelated
to study medication.
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