Ok today is day 4 and so far there are no side effects. I feel fine. I realized I never explained my questions from Thursday and Kristen’s answers, so here goes.
1. If this drug ends up being approved and released and I was on the placebo, can I then take the real drug? Answer: Yes I can. I can also do other drug studies in the future.
2. If I don’t get the stomach upset does that mean I am on the placebo? Answer: No, not at all. Kristen receives status on patients from the drug company, and she said those people that do have the most stomach upset are also taking chemo drugs at this time. Apparently there is not a large group of people yet not on chemo like me that are testing the drug. So I should not be disappointed I am not shoveling down the Imodium today. :0)
3. Should I expect to get a full physical exam every time I come into the office, to include a vaginal exam? Answer: Yes. And blood work each time.
4. Do I really need to call at 2am if I have diarrhea before I take an Imodium? (This is in the instruction booklet.) Answer: Yes. The doctor on call needs to know if this side effect appears, and monitor it closely. Call anytime day or night if needed.
5. Besides the list of drugs I was given in the packet that I could not take can I take whatever else I need to without contacting them first? Meaning, can I pop an Advil if my back hurts? Can I take some Airbourne if I’m going to fly? Answer: Yes. As long as it’s logged in the log book, and it’s not on the list I can take it.
I’ve mentioned above the log book and the packet. Both go hand in hand, the packet contains the agreement I signed, as well as instructions, what medicines I cannot take, several logs, and numbers to call if needed. Each day I am to log my dose, any other medicines I took, and any side effects I am having. Also each time I go into the office I use a pilot (cell phone) to fill out a 25-30 question survey asking a ton of questions about how I am feeling both physically and emotionally. I was given my pills by Kristen, and I am to return the bottle to her and get another one each visit. Everything I do, whether on the computer, pill bottle, or logs is all tracked by number only. To the drug company I am a number not a name. The study seems very well run, and extremely organized. My information is all kept private, and even the survey I take is password protected (with a password selected by me).
Guess that’s all of the nuts and bolts. Wanted to make sure I included that info for anyone thinking about doing the trial…..