Adverse Events for VOICE
Additional Examples
Is it an Adverse Event?
Suppose a participant is found to have a grade 3
ALT after her Month 1 visit. Is this an adverse event?
Is it a reportable adverse event?
Is it an Adverse Event?
Suppose a participant is found to have a grade 1
ALT after her Month 1 visit. Is this an adverse event?
Is it an Adverse Event?
Suppose a participant is found to have a grade 1
ALT after her Month 1 visit. Her baseline labs at
Screening Part 1 were normal. Is this an adverse
event? Is it reportable?
Is it an Adverse Event?
Suppose a participant is found to have a grade 1 ALT after
her Month 1 visit. Her baseline labs at Screening Part 1 were
normal. Per protocol, you repeat her lab tests one week later
and her ALT is normal. She presents for Month 3 visit and
you repeat ALT as per the protocol. Now her ALT is a grade 1.
In this scenario. How many AEs have occurred?
Is it an Adverse Event?
Suppose a participant is found to have a grade 1 ALT after
her Month 1 visit. Her baseline labs at Screening Part 1 were
normal. Per protocol, you repeat her lab tests one week later
and her ALT is normal. She presents for Month 3 visit and
you repeat ALT as per the protocol. Now her ALT is a grade 1.
In this scenario. How many AEs have occurred? Are any
reportable? Are any serious?
Is it an Adverse Event?
Suppose a participant presents for her Month 5 visit and
reports burning with urination and urinary frequency. You
decide to do a urine dipstick in light of her symptoms
suggestive of a urinary tract infection. The dipstick is positive
for leukocyte esterase, negative for nitrite, positive for protein
(1+) and negative for glucose. Has an AE occurred? If so,
how many? Which, if any, are reportable? Are any serious?
Follow-Up
Suppose a participant presents for her Month 5 visit and
reports burning with urination and urinary frequency. You
decide to do a urine dipstick in light of her symptoms
suggestive of a urinary tract infection. The dipstick is positive
for leukocyte esterase, negative for nitrite, positive for protein
(1+) and negative for glucose.
You elect to treat these symptoms with an antibiotic because
your suspicion for a urinary tract infection is high. When will
you have her come back to the clinic?
Is it an Adverse Event?
Suppose a participant presents for her Month 5 visit and
reports burning with urination and urinary frequency. You
decide to do a urine dipstick in light of her symptoms
suggestive of a urinary tract infection. The dipstick is positive
for leukocyte esterase, positive for nitrite, positive for protein
(1+) and negative for glucose. Has an AE occurred? If so,
how many? Which, if any, are reportable? Are any serious?
Follow-Up
Suppose a participant presents for her Month 5 visit and
reports burning with urination and urinary frequency. You
decide to do a urine dipstick in light of her symptoms
suggestive of a urinary tract infection. The dipstick is positive
for leukocyte esterase, positive for nitrite, positive for protein
(1+) and negative for glucose.
You elect to treat these symptoms with an antibiotic because
your suspicion for a urinary tract infection is high. When will
you have her come back to the clinic?
Follow-Up
Suppose a participant presents for her Month 5 visit and reports burning
with urination and urinary frequency. You decide to do a urine dipstick in
light of her symptoms suggestive of a urinary tract infection. The dipstick
is positive for leukocyte esterase, positive for nitrite, positive for protein
(1+) and negative for glucose.
You elect to treat these symptoms with an antibiotic because your
suspicion for a urinary tract infection is high. You ask her to come in for a
urine dipstick per protocol 10 days after the proteinuria was detected in
the clinic.
The dipstick is negative for proteinuria.
What is the resolution date for the urinary tract infection adverse event?
Follow-Up
Suppose a participant presents for her Month 5 visit and reports burning
with urination and urinary frequency. You decide to do a urine dipstick in
light of her symptoms suggestive of a urinary tract infection. The dipstick
is positive for leukocyte esterase, positive for nitrite, positive for protein
(1+) and negative for glucose.
You elect to treat these symptoms with an antibiotic . You ask her to
come in for a urine dipstick per protocol 10 days after the proteinuria was
detected in the clinic. She has no complaints. You perform a dipstick and
find that the proteinuria is still 1+.
The participant completed treatment and has not other symptoms besides
the 1+ protein result. Can you resolve the urinary tract infection AE now?
Is it an Adverse Event
• Suppose a participant presents for her month 6 visit and
reports that she was admitted to the hospital 3 weeks
prior after an argument with her husband escalated and
he stabbed her in the neck. She was hospitalized for 1
week at which point she underwent exploratory surgery
in her neck. Today she feels well and is noted to have a
5 cm scar on the right side of her neck. Has an AE
occurred? How many? Which, if any, are reportable?
Which, if any, are serious? Which, if any, are EAEs?
Is it an Adverse Event?
• Suppose a participant presents for her month 6 visit and
reports that she was admitted to the hospital 3 weeks
prior after an argument with her husband escalated and
he stabbed her in the neck. She was hospitalized for 1
week at which point she underwent exploratory surgery
in her neck. Today she feels well and is noted to have a
5 cm scar on the right side of her neck. Has a social
harm occurred? Should it be reported?
Is it an Adverse Event?
• A woman presents for her enrollment visit and complains
of a thick vaginal discharge and itch. You perform a
pelvic exam and wet mount and diagnose the woman
with a candida infection. Has an AE occurred?
Is it an Adverse Event
• A participant presents for her Month 12 visit and is found
to have a positive pregnancy test. Has an AE occurred?
Is it an Adverse Event
• A participant presents for her Month 12 visit and is found
to have a positive pregnancy test. She continues in the
study off product and at her Month 18 visit, when she is
25 weeks pregnant, she reports an episode of vaginal
bleeding. Has an AE occurred? What term would you
use to describe it?
Is it an Adverse Event
• A participant presents for her Month 12 visit and is found
to have a positive pregnancy test. She continues in the
study off product and at her Month 18 visit, when she is
25 weeks pregnant, she reports an episode of vaginal
bleeding and cramping. You refer her to the local
hospital where she goes on to deliver later that day. Her
baby was still born at delivery. In this scenario has an AE
occurred? Is so, how many?
Is this an Adverse Event?
• A participant’s mother calls to notify the site that her
daughter was hospitalized with dehydration secondary to
nausea and vomiting yesterday. The mother relays to
you that her daughter is receiving IVF but beyond that
she does not know what the underlying diagnosis is or
what other treatment the participant is receiving. Has an
AE occurred? If so, how many?
Is this an SAE?
• A participant’s mother calls to notify the site that her
daughter was hospitalized with dehydration secondary to
nausea and vomiting yesterday. The mother relays to you that
her daughter is receiving IVF but beyond that she does not
know what the underlying diagnosis is or what other
treatment the participant is receiving. Have any reportable
AEs occurred? Are any serious?
Is this an EAE?
• A participant’s mother calls to notify the site that her
daughter was hospitalized with dehydration secondary to
nausea and vomiting yesterday. The mother relays to
you that her daughter is receiving IVF but beyond that
she does not know what the underlying diagnosis is or
what other treatment the participant is receiving. Have
any expedited AEs occurred? If so, when do the sites
need to notify DAIDS?
Is this an Adverse Event?
• A participant presents to her Month 15 visit and
reports a three day history of headache, fever,
and abdominal pain. Has an AE occurred? If so,
how many AEs? Are they reportable?
Is this an Adverse Event?
• A participant presents to her Month 15 visit and
reports a three day history of headache, fever,
and abdominal pain. After your assessment you
grade the AEs as follows: Grade 1 fever, Grade
2 headache, Grade 2 abdominal pain. How
many AEs are reportable?
Is this an Adverse Event?
• A participant presents to her Month 15 visit and reports a
three day history of headache, fever, and abdominal
pain. After your assessment you grade the AEs as
follows: Grade 1 fever, Grade 2 headache, Grade 2
abdominal pain. You perform laboratory tests and find
that she has a grade 1 AST, grade 2 ALT and a positive
blood smear for malaria. How many AEs have occurred?
Which are reportable?
Is this an Adverse Event?
• You learn that a participant was in a motor vehicle
accident and suffered a broken arm and laceration on
her head. She was evaluated in the casualty department
but not admitted to the hospital. Have any AEs occurred?
If so, how many? How many are reportable?
Is this an Adverse Event?
• You learn that a participant was in a motor vehicle
accident and suffered a broken arm and laceration on
her head. She was evaluated in the casualty department
but not admitted to the hospital. She presents to the
clinic three days after the accident with erythema and
purulent discharge from her face laceration. In total, how
many AEs have occurred? How many are reportable?
Is this an Adverse Event
• A participant presents for her Month 12 visit and is noted
to have a small ulcer on her right labia. It is non tender
and she was unaware of it. She is on oral product. Has
an AE occurred? What if the participant complained
about the lesion, would an AE have occurred in that
situation?
Is this an Adverse event?
• A participant’s baseline creatinine is 0.4.
(ULN=1.2). At her Month 9 visit she is found to
have a creatinine of 0.7. Has an AE occurred?
Is this an Adverse Event?
• A participant presents to her Month 6 visit
complaining of dysuria, frequency, and
hematuria. Has an AE occurred?
Is this an Adverse Event?
• A participant presents to her Month 6 visit complaining of
dysuria, frequency, and hematuria. You dip her urine and
find +leukocytes, + blood, +nitrites, and 1+ proteinuria.
Has an AE occurred? If so, how many? Are any
reportable? Are any serious?
Is this an Adverse Event?
• A participant presents to her Month 6 visit complaining of
dysuria, frequency, and hematuria. You dip her urine and
find +leukocytes, + blood, +nitrates, and 1+ proteinuria.
You prescribe an antibiotic and ask her to call the site if
her symptoms do not resolve within 5 days. She
presents to the clinic 3 days later with complaints of
fever, chills, and back pain. You suspect pylenephritis
and send her to the casualty department for evaluation.
She is ultimately admitted to the hospital for two days of
antibiotics. In this scenario, how many AEs have
occurred? Are they serious?