http://www.100md.com
中医循证医学
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.
, 百拇医药
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.
, 百拇医药
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.
, 百拇医药
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. , http://www.100md.com
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.
, 百拇医药
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.
, 百拇医药
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.
, 百拇医药
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. , http://www.100md.com