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Adverse Effects Symptoms
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Abdominal Pain
Nausia
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Abdominal Pain
When did the symptoms start?
Exact Date or Approximate Date Symptoms Started
Exact Date Symptoms Started
Approximate Date Symptoms Started
Do you still have pain?
Yes
No
When did the symptom stop?
Exact or Approximate Date
Exact Date Symptoms Stopped
Approximate Date Symptoms Stopped
Is (was) the pain:
Sharp
Dull
Throbbing
Burning
Cramping
Check all that apply
How would you grade the intensity of the pain?
Refer to the visual analog pain scale.
0 Doesn’t Hurt
2 Hurts a Little Bit
4 Hurts a Little More
6 Hurts Even More
8 Hurts a Whole Lot
10 Hurts Worst
Visual Pain Scale
Does (did) the symptom disrupt your sleep?
Yes
No
Where in the abdomen is (was) the pain mainly located?
Refer to Figure 1 Check All That Apply
Throughout the entire abdomen
The upper right side (RUQ)
The lower right side (RLQ)
The upper left side (LUQ)
The lower left side (LLQ)
The upper central area (epigastric)
The middle central area (periumbilical)
The lower central area (suprapubic)
Figure 1
8. Is (was) the abdominal pain localized meaning that you can point to the painful area with just one finger or is the pain more generalized?
Localized
Generalized
Does (did) the pain radiate?
Yes
No
Where does (did) the pain radiate?
Refer to Figure 1 Check All That Apply
Throughout the entire abdomen
The upper right side (RUQ)
The lower right side (RLQ)
The upper left side (LUQ)
The lower left side (LLQ)
The upper central area (epigastric)
The middle central area (periumbilical)
The lower central area (suprapubic)
Figure 1
If you are still having this symptom, is it:
Worsening
Stable
Improving
Unsure
No Longer Having Pain
The symptom
Has not affected my daily routine at all
Has caused me to cancel some of my daily routine
Has caused me to cancel all of my daily routine
Is (was) there any abdominal tenderness (meaning is there an area that is tender to touch)?
Yes
No
Have you had any recent trauma before the symptom began?
Yes
No
Is (was) the abdominal pain positional (I.e. is it better or worse in any given position)?
Yes
No
Does (did) anything appear to lessen or improve the symptom?
Yes
No
What?
Does (did) anything appear to worsen the symptom?
Yes
No
What?
18. Does (did) taking a deep breath worsen the abdominal pain
Yes
No
Are you under any unusual stress?
Yes
No
Brief Description
Did anything appear to cause this symptom?
Yes
No
Brief Description
Did you begin any new medications (either prescription or OTC) before this symptom started?
Yes
No
What?
Had the dosage for any prescription medications been changed before this symptom started?
Yes
No
What?
Is (was) the abdominal pain related to eating?
Yes
No
Eating
Tends (tended) to make the pain better.
Tends (tended) to worsen.
Is unrelated to the pain.
Did you have fever?
Yes
No
Did you measure your temperature?
Yes
No
How high was your temperature?
Did you take anything for fever?
Yes
No
What did you take?
Did you take any medication, including prescription or OTC, for this symptom?
Yes
No
What did you take?
Did this medication help?
Yes
No
Did you seek medical attention for this symptom?
Yes
No
Were any tests performed?
Yes
No
What were the results?
Was a diagnosis made?
Yes
No
What was it?
Did you go to the ER?
Yes
No
Were you admitted to the hospital?
Yes
No
You did not seek medical attention:
Because you were not that concerned.
Because the problem had already resolved.
Because you already knew what caused it.
Because you knew we would be checking on you.
Some other reason
Please describe
Have you had problems with this symptom in the past?
Yes
No
Did seek medical attention for any similar previous episode?
Yes
No
Was a diagnosis made?
Yes
No
What was the Diagnosis?
Did any previous episode occur during the study?
Yes
No
How frequent is this symptom?
Is the symptom:
Increasing in frequency?
Stable?
Decreasing in frequency?
Unsure?
How long does the symptom generally last?
Does exertion seem to bring on these episodes of abdominal pain?
Yes
No
Does anything else seem to bring on episodes of this symptom?
Yes
No
What?
Does anything seem to improve these episodes?
Yes
No
What
What do you think might be causing these episodes?
How long after taking study medication did the symptom begin?
Are you to receive more than one dose of study medication?
Yes
No
Did you stop, or were you instructed to stop, the study medication?
Yes
No
Did you re-start it?
Yes
No
Did the symptom return after you re-started the study medication?
Yes
No. STOP
Are (were) there any other associated symptoms?
Yes
No
Identify the associated symptoms that you have (had):
Nausea
Vomiting
Other
What?
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Nausia
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