Ethical statement for PRO-ACT
In all of the trials that generated the data included in this database, study protocols
were approved by the participating medicalcenters and all participating
patients gave informed consent. De-identified data from these trials were
donated to the PRO-ACT database for research purposes only and
under the explicit conditions that Prize4Life and all users of the data would
maintain the anonymity of subjects and not attempt to discover the identity of
any subject. In the rare cases where donated data was not already
completely anonymized, donated data was further anonymized following the HIPAA
de-identification conventions for personal health information: any potential
patient initials and/or dates of birth were removed, new randomized subject
numbers were created, and wherever possible, trial-specific information was
removed in the merging of datasets, including trial center identity and location,
trial dates, or other identifying information.
Amyotrophic lateral sclerosis, or ALS (also known in the US as Lou Gehrig’s
Disease and as Motor Neuron Disease in the UK) is a disease that involves the
degeneration and death of the nerve cells in the brain and spinal cord that
control voluntary muscle movement. Death typically occurs within 3 - 5 years of
diagnosis. Only about 25% of patients survive for more than 5 years after
PRO-ACT includes information from over 8500 ALS patients who participated in industry clinical
trials. The data is de-identified to protect patient privacy. Different types
of information may be available for different patients because multiple trials
were merged to create PRO-ACT. Some patients received placebo treatments, while others received experimental
treatments (medication), however the medications tested in these specific
trials were found to be no better than placebo with respect to their effects on
For every type of information available
there is a data file and a dictionary file. Each subject is identified by a
SubjectID and the specific assessment for this subject is identified by a
record (each subject has multiple records). The assessments are separated into
different files according to type:
- Death Report
- Family History
- Forced Vital Capacity
- Laboratory Data
- Riluzole use
- Slow Vital Capacity
- Subject ALS History
- Treatment Group
- Vital Signs
The time at which an assessment was taken (a record was created) is listed as the assessment’s
delta. Delta is given as days since the trial onset. A negative delta lists
events occurring before the official beginning of the trial.
How to use the data dictionary
For each type of information available, there are two files, a data file and a data dictionary file. The
data dictionary specifies the types of information available in the data file
(i.e. the different columns in the data file). In the data file you will find a
SubjectID for each patient, indicating which subject it is. You will find the
same SubjectID across different files for different assessments e.g. if the
same patient had both vital signs and lab tests measured, those respective
records will include the same SubjectID.
Beyond the SubjectID, the data files contain different assessments and their respective results including
value, unit of measurement, and delta (time in days from trial onset when the
assessment was made). You can identify these variables through the column name
in the data file.
For example, in the demographics file:
||Race - Black/ African American
||Race - Caucasian
You can see here that the patient whose subjectID is 329 was measured on Delta=0 (first day of the trial)
and was a female, African American, and her age was 38 years. You can also see
that some measures are missing.
The exact medications used in the trials
are not specified, as part of our effort to avoid identification of the
patients involved, however, information is available as to whether any
individual patient received medication or placebo, and this information is
listed in the Treatment Group file as [Treatment Group- Study Arm- Active;
indicating experimental treatment was given or Treatment Group- Study Arm- Placebo; indicating placebo was given].
[Treatment Group Delta] refers to
the time duration between the first time the patient was assessed during the
trial and the time medication (or placebo) was first given. The first time the
patient was assessed during the trial (typically screening visit) is indicated
as Time 0. The time medication/placebo was given, is the time in days since
that first day. Note that different patients started their respective trials at
While no overall benefits were detected in the treatment arms of the trials incorporated,
in a few studies patients seemed to do slightly worse in the treatment arm.
It is unclear whether this was a specific effect of the given drug or reflected the difficulties inherent in truly balancing patients across arms.
Family and Medical History
ALS affects approximately 5 out of every 100,000 people worldwide. In about 5%
of cases, ALS is caused by a genetic defect that occurs in multiple family
members and this form is known is ‘familial ALS’. In the remaining cases, the
cause of ALS is largely unknown and is not obviously hereditary. For this
reason, the data –the file Family History- contains information about close
family members [Family History Delta, Aunt, Aunt (maternal), Aunt
(paternal), Cousin, Cousin (paternal), Cousin (maternal), Father, Grandfather,
Grandfather (maternal), Grandfather (paternal), Grandmother, Grandmother
(maternal), Grandmother (paternal), Mother, Nephew, Niece, Sibling, Uncle
(maternal), Uncle (paternal), Son, Daughter, Sister, Brother. We have tried
to provide as much information as possible; the different labels are due to
differences in the information collected by various trials.
Some medical history is also available
for the patients themselves- [Neurological Diseases (list)
and Neurological Diseases Other: Specify].
Demographic information is available in the Demographics file -including [Age,
Gender, Race and Ethnicity, Age at Onset] at screening.
Subject ALS history
The major symptoms of ALS broadly include
muscle weakness, paralysis, drooling, gagging, muscle cramps, involuntary
muscle contractions/twitches called fasciculations, speech problems,
significant weight loss (“wasting”), and breathing problems. ALS typically does
not affect the senses (sight, smell, taste, hearing, touch). Specific symptoms
of the clinical trial participants are listed in the data- in the file Subject
ALS History- as [Symptom, Symptom Other: Specify, and Location (which
body part is manifesting the symptom)].
As ALS progresses, patients lose their
ability to control voluntary muscle function. Symptoms progress from muscle
weakening, twitching, and an inability to move the arms, legs, and body, into
full paralysis. When the muscles in the chest area stop working, it becomes
hard or impossible to breathe on one's own.
The site of disease onset as experienced
by the patient can be a limb (“limb onset”) or the muscles controlling speaking
and swallowing (“bulbar onset”) or occasionally both. Information is available
in the database regarding a given patient’s site of onset [Limb, Bulbar,
Other, Limb and Bulbar, and Spine (which is synonymous with limb
onset; different terminology was used for different patients)].
Over time, the disease progresses to
other sites. An ALS diagnosis is currently confirmed only when symptoms appear
in more than one site. The gap in time between onset of symptoms and diagnosis
is on average more than a year. The time from disease onset, time from
diagnosis, or time from both is available for many of the patients [Onset
Delta- the time between disease onset and the first time the patient was
tested in a trial; Diagnosis Delta- the time between clinical
diagnosis and the first time the patient was tested in a trial; the difference
between these two values is the time between onset and diagnosis]. Note that
both of these events (onset and diagnosis) always occurred prior to the start
of the trial, therefore the deltas for each of these events are always negative
(as for purposes of calculating deltas, the start of the trial is considered to
be time 0).
Symptoms and outcome measures (FVC, SVC, ALSFRS, and Survival files)
Symptom severity is frequently assessed using two functional scales: ALSFRS
(ALS Functional Rating Scale) and its modified version ALSFRS-R. The ALSFRS scale
is a list of 10 assessments regarding motor function, with each measure ranging
from 0 to 4, with 4 being the highest (normal function) and 0 being no
function. The score for the individual questions are then summed together to
generate a number, and that is the ALSFRS score.
ALSFRS-R is a modified version of the
ALSFRS. Whereas in the ALSFRS there are 10 assessments, in the ALSFRS-R one of
the assessments, #10 (respiratory function) was further divided into three
questions to better reflect the importance (weighting) of respiratory changes
within the scale. Therefore ALSFRS-R, contains 12 questions (9 of these
identical to the traditional ALSFRS) and a maximal score of 48. Please note
that some of the patients in the dataset will have ALSFRS scores and some will
have ALSFRS-R. ALSFRS and ALSFRS-R information is available in the file ALSFRS(R).
The individual questions comprising the
ALSFRS or ALSFRS-R scores are available in the data dictionary [ALSFRS Speech,
Salivation, Swallowing, Handwriting, Cutting (with and without Gastrostomy) (gastrostomy
is a feeding tube so each patient will have a score for either with
gastrostomy, i.e. they don’t need to cut their food so the score is based on a
related fine motor set of questions, or without gastrostomy, not both), Dressing
and Hygiene, Turning in Bed, Walking, Climbing Stairs, Respiratory]. In [ALSFRS-R
Speech, Salivation, Swallowing, Handwriting, Cutting (with and without
Gastrostomy), Dressing and Hygiene, Turning in Bed, Walking, Climbing Stairs,
Dyspnea, Orthopnea, Respiratory Insufficiency]. The total sum is available
as [ALSFRS Total, ALSFRS-R Total]. The time between the first time a
patient was observed (Time 0) and the time of each assessment of ALSFRS or
ALSFRS-R over the course of the trial is listed as [ALSFRS-Delta (regardless
of whether it was ALSFRS or ALSFRS-R)].
The full ALSFRS assessment (list of questions) is available at the end of the document.
In cases where one question was missing, but scores available for that question from preceding and proceeding measures,
the score was imputed by the original data donors.
This sometimes results in non-integer scores (such as 1.5, 2.5, etc).
In addition to ALSFRS, there is another
frequently used measure of ALS disease status called forced vital capacity or
FVC. Forced vital capacity is the volume of air that can forcibly be blown out
after full inspiration, measured in liters. FVC is available- in the file
Forced Vital Capacity- for some of the patients. FVC is typically reported in
the literature as percentage of normal but in this dataset the FVC is available
as [Subject Liters, Subject Normal (the expected value for a
non-ALS patient (control) matched by gender, age and height), Forced
Vital Capacity Units (liters) and Forced Vital Capacity Delta (time
of test from the start of the trial)]. For example, if you divide [Subject
Liters] by [Subject Normal], you will end up with a number which is
the percentage of normal lung function (so 120% is an athlete, 100% is normal,
80% is deteriorating, and 50% is very low breathing capacity/ready for a
ventilator). Another measure of lung function- available in the file Slow Vital
Capacity- is slow vital capacity (SVC). Slow vital capacity is the maximum
volume of air that can be exhaled slowly after slow maximum inhalation, also
measured in liters [Subject Liters] and the time of assessment is given
as [Slow Vital Capacity Delta]. SVC is typically greater than FVC.
Finally, for some patients, time of death
is available- in the file Death Report- whether the subject died [Subject Died]
while monitored and if Yes, time measured in days from trial onset [Death Days].
Vital sign data collected for each patient-available in the file Vital Signs- within
the different trials include: [Vital Signs Delta]- the time when they
were assessed compared to Time 0. Blood pressure and pulse: [Blood Pressure
(Diastolic), Standing Blood Pressure (Diastolic), Baseline Standing Blood
Pressure (Diastolic), Endpoint Standing Blood Pressure (Diastolic), Supine
Blood Pressure (Diastolic), Baseline Supine Blood Pressure (Diastolic),
Endpoint Supine Blood Pressure (Diastolic), Blood Pressure (Diastolic)
Units-mmHg, Blood Pressure (Systolic), Standing Blood Pressure (Systolic),
Baseline Standing Blood Pressure (Systolic), Endpoint Standing Blood Pressure
(Systolic), Supine Blood Pressure (Systolic), Baseline Supine Blood Pressure
(Systolic), Endpoint Supine Blood Pressure (Systolic), Blood Pressure
(Systolic) Units-mmHg, Pulse, Standing Pulse, Baseline Standing Pulse, Endpoint
Standing Pulse, Supine Pulse, Baseline Supine Pulse, Endpoint Supine Pulse,
Pulse Units-Beats per minute].
Height and weight: [Height, Height units (inches and centimeters), Weight,
Weight units (grams, kilograms and pounds), Baseline Weight, Endpoint Weight]
Body temperature- [Temperature, Temperature Units –F, Temperature Units- C]
Respiratory rate- [Respiratory Rate, Respiratory Rate Units (Breaths per
For each lab test there is [Test Name, Test Result, Test Unit and Laboratory
Delta (time from the start of the trial)]. Note that a lab test result
can be within the normal range and may still be relevant for predicting ALS
progression (depending on where it falls within the normal range), and also
that normal ranges vary according to different sources. Also note that there
may be cases where mistakes were made in data entry leading to abnormally high
or low (non-physiological) levels of certain measures in this database, so be
mindful of this in your analysis and interpretation.
In building PRO-ACT, as part of our data cleaning process for the lab data, units were converted, synonymous tests appearing with different names were merged,
and some indecipherable data (less than 1%) were removed (see full list of cleaning changes here ).
Lab test data within PRO-ACT include :
Urine pH- the level of acidity of the urine. Levels range between 4.5 to 8 (optimal is 6).
detects excessive protein escaping into the urine, to help evaluate and monitor
kidney function, and to detect kidney damage. Normal range is 0-20 mg/dL. Note
that in the database non-physiological values are most likely due to mistakes
in data entry .
Gravity- (sometimes listed as Specific gravity) relates to the degree of
concentration of the urine, indicative of kidney function. Normal ranges are
Urine Glucose- levels
of glucose in urine (measured by mg/dL). Normally, they should be zero.
Urine WBC (white
blood cells)- Should be negative. Presence may indicate higher than normal
activation of the immune system (such as in the case of infection).
measuring specifically leukocyte WBC’s in the blood- should be <10 U/L.
Urine Blood- measure of hemoglobin. Should be negative.
Urine RBCs (red blood cells)- measure of bleeding. Should be < 3.0.
Urine casts- another measure of bleeding. Should be negative.
Urine Ketones- the
levels of Ketone bodies found in urine, indicating starvation or carbohydrate
deprivation leading to protein breakdown. Should be negative.
Items regarding Urine Appearance include [Urine appearance, Urine Color, Urine Clarity
Items regarding infection in Urine include [Urine Bacteria, Urine Culture and Urine Mucus].
Other measures include availability of extracts in Urine:[Urine Albumin, Urine
bilirubins, Urine Hemoglobin, Urine Glucose, Urine Urobilinogen, Urine Urea,
Urine Uric Acid, Urine Uric Acid Crystal, Urine Crystals, Urine Calcium Oxalate
Crystals, Urine Amorphous Crystals, Urine Nitrite, Urine Potassium, Urine
Sodium. (Note that some measures are listed only as – or as ‘Normal’ or on the
scale of ‘Trace’, ‘Small’, ‘Moderate’ and ‘Large; without any precise numerical
Albumin- a small
protein produced in the liver, is the major protein in blood serum. Used to
assess liver disorder or kidney disease or to evaluate nutritional status. Both
increases and decreases can be significant. Normal ranges are 35- 50 g/L.
Protein- A measure of
all blood protein including Albumin. Used to assess nutritional status or to
screen for certain liver and kidney disorders. Both increases and decreases can
be significant. Normal ranges are 60 – 84 g/L.
Sodium – Abnormal
levels are associated with kidney malfunction and many other pathophysiological
changes. Normal ranges are 133 - 146 mmol/L (note that values are sometimes
reported as lower than physiologically reasonable beyond reasonable range).
ranges are 3.5 - 5.4 mmol/L (note that values are sometimes high beyond
Associated also with acid-base (pH) imbalance. Normal ranges are 18 - 23 mmol/L.
also with acid-base (pH) imbalance. Normal ranges are 98 - 106 mmol/L (Note
that some measures are listed only as –, without any precise numerical value).
Anion Gap: The
balance of anions and cations. Normal ranges are <11 mmol/L. If the gap is
greater than normal, then high anion gap metabolic acidosis is diagnosed.
to assess to likelihood of magnesium, poisoning. Normal ranges are or 0.6-0.82
Blood Urea Nitrogen
(BUN), also known as Urea. This is a product of the kidney’s normal function
found in urine. Normal ranges are 1.2-3 mmol/l. (note that values are sometimes
high beyond reasonable range).
Uric Acid- Digestive
product dissolved by the kidneys. High levels might indicate kidney dysfunction
or other pathophysiological changes (like gout) and are generally thought to be
unhealthy within themselves. Normal ranges are 180-480 umol/L. Note that low
levels of uric acid have been shown to predict worse prognosis in ALS and Uric
acid is the only lab test currently known to be related to prognosis in ALS.
ranges are 53-106 mmol/L for males. Normal BUN/ Creatinine ratios are 5-35.(note
that values are sometimes high beyond reasonable range).
(ALP)- also listed as SPGT. Also associated with bone dysfunction. Normal
ranges 50 - 160 U/L.(note that values are sometimes high beyond reasonable
range and that some measures are listed only as –, without any precise
ALT (alanine amino
transferase, also called SGPT)- Also associated with diseases of the biliary
system. Normal ranges are 1 - 21 U/L.(note that values are sometimes high beyond
reasonable range and that some measures are listed only as –, without any
precise numerical value).
Elevated serum GGT activity can be found in diseases of the liver, biliary
system, and pancreas. Normal ranges are 5 - 40 U/L.
AST (aspartate amino
transferase, also called SGOT). Normal ranges are 7 - 27 U/L.(note that values
are sometimes high beyond reasonable range and that some measures are listed
only as –, without any precise numerical value).
Bilirubin (Total, Direct and Indirect )- Also associated with Anemia. Normal ranges are -5-17
umol/l for Bilirubin (Total=direct+indirect), 1-5 umol/L for bilirubin (Direct)
and 4 -12 for Bilirubin (Indirect).
White Blood Cell
(WBC)- a count of the actual number of white blood cells per volume of blood.
Both increases and decreases can be significant. Normal ranges are 4.3-10.8
White blood cell
differential looks at the types of white blood cells present. There are five
different types of white blood cells, each with its own function in protecting
us from infection. Quantities of the various white blood cell types are listed
below as either percentage or volume:
named Segmented Neutrophils. Normally the most abundant type of white blood
cell in healthy adults, important in fighting inflammation. Normal ranges are
1.3-5.4 *109/L (Absolute Neutrophil Count) cells or 45-62% (Neutrophils).Note
that some measures are listed only as – or as ‘Normal’, without any precise
Band Neutrophils- are
important in inflammation. Normal ranges are 0-0.7*109/L cells (Absolute Band
Neutrophil count)or 3-5%(Band Neutrophils). Note that some measures are listed
only as – or as ‘Normal’, without any precise numerical value.
Lymphocytes- make up
about 25% of the total white blood cell count but can vary widely. Lymphocytes
occur in two forms: B cells, which produce antibodies, and T cells, which
recognize foreign substances and process them for removal. Normal ranges are
0.7-3.9 *109/L cells (Absolute Lymphocytes Count) or 16-33% (Lymphocytes). Note
that some measures are listed only as – or as ‘Normal’, without any precise
Monocytes - function
in the ingestion of bacteria and other foreign particles. Monocytes make up
5-10% of the total white blood cell count. Normal ranges are 0.1-0.8 *109/L
cells (Absolute Monocyte Count) or 3-7%(Monocytes).Note that some measures are
listed only as – or as ‘Normal’, without any precise numerical value.
believed to function in allergic responses and in resisting some infections.
Normal ranges are 0-0.5 *109/L cells (absolute Eosinophil count) or 1-3%
(Eosinophils). Note that some measures are listed only as –, without any
precise numerical value.
constitute 1% or less of the total white blood cell count but may increase or
decrease in certain diseases. Normal ranges are 0-0.4*109/L (Absolute Basophil
Count) or 0-0.75%(Basophils). Note that some measures are listed only as – or
as ‘Normal’, without any precise numerical value.
Red Blood Cells (RBC)
- a count of the actual number of red blood cells per volume of blood. Both
increases and decreases can point to abnormal conditions. Normal ranges are 4.2
- 6.9 *109/L.
RBC (red blood cell)
Morphology- Abnormal morphology is found in certain blood diseases such as
Hemoglobin - measures
the amount of oxygen-carrying protein in the blood. Lower levels are associated
with Anemia. Normal ranges are Male: 130 - 180 g/L; Female: 120 - 160 g/L.
Hematocrit - measures
the percentage of red blood cells in a given volume of whole blood. Normal
ranges are Male: 45%-62%; Female: 37%-48% (out 100%).
Hemoglobin Count-a measure of concentration of Hemoglobin in a given volume of
red blood cells (calculated by Hemoglobin/Hematocrit). Normal levels are
320-360 g/L or 32-36%.
Volume- Average red blood cell volume. Normal levels are 80-99 fL.
Hemoglobin- Average levels of hemoglobin per red blood cell. Normal levels
are 27-31 pg/cell.
Platelets- the number
of platelets in a given volume of blood. Both increases and decreases can point
to abnormal conditions of excess bleeding or clotting. Normal ranges are
150-350 *109/L cells (note that values are sometimes high beyond reasonable
blood plasma glycoproteins that control the level of free iron in the blood.
Both abnormally high and abnormally low levels may be indicative of Anemia.
Normal ranges are 204–360 mg/dL
CK (Creatine Kinase)-
Increases may indicate a heart attack or other muscle damage. Normal ranges are
Male: 38 - 174 u/L; Female: 96 - 140 u/L (note that values are sometimes high
beyond reasonable range, and that some measures are listed only as – or as
‘Normal’, without any precise numerical value).
measured to assess the risk of developing heart disease, with increased
triglyceride levels correlating with increased risk. Normal ranges depend on
age: Ages 10-39 0.61-1.3 mmol/L; ages 40-59 0.77-1.7 mmol/L; age 60+ 0.9-1.7
mmol/L. Generally recommended to be kept <1.1 mmol/L (note that values are
sometimes high beyond reasonable range).
measured to assesses the risk of developing heart disease, with increases in
cholesterol correlating with increased risk. Normal ranges are 3-5 mmol/L,
recommended to be kept no higher than 3.9 mmol/L.
dehydrogenase- an enzyme involved in tissue breakdown, most commonly heart
muscle damage, but also other tissues. Normal ranges are 50-150 U/L.
glucose in the blood. Both increased and decreased levels can be significant.
Normal ranges are 3.8-6 mmol/L (Note that some measures are listed only as Trace,
Small, Moderate or Large, without any precise numeric value).
Hemoglobin)- is a form of hemoglobin that is measured primarily to identify the
average plasma glucose concentration over prolonged periods of time. It is
formed in a non-enzymatic glycation pathway by hemoglobin's exposure to plasma
glucose. Units are percentages. Level ≥ 6.5% serves as a criterion for
the diagnosis of diabetes (Note that some measures are listed only as ‘Normal’,
without any precise numeric value).
metabolic panel to assess kidney, bone, or nerve disease. Both increased and
decreased levels can be significant. Normal ranges are 2.2-2.5 mmol/L (note
that values are sometimes high beyond reasonable range).
to level of Calcium. Associated with kidney function, nutritional status, and a
variety of chronic illnesses. Both increased and decreased levels can be
significant. Normal ranges are 1-1.5 mmol/L.(Note that some measures are listed
only as –, without any precise numerical value)
Hepatitis - A,B,C
antigen and antibody. Positive antibody levels indicate vaccination. Positive
antigen levels indicate that the person is more infectious.
(Immunoglobulin A, G, M)-antibody isotypes. IgG isthe major one found in blood.
Normal range: for Immunoglobulin A 85-385mg/dL, for Immunoglobulin G 565-1765
mg/dL and for Immunoglobulin M 55-375 mg/dL.
Gamma Globulin- a
class of globulin of which Immunoglobulin G is the most common. Normal levels
are 2-3 g/dL. Indicative of inflammation.
Stimulating Hormone)- A hormone that stimulates the thyroid gland to produce
factors which stimulate the metabolism of almost every tissue in the body. Both
increased and decreased levels can be significant. Normal ranges are 0.4-3 U/L.
Free T3- activated by
TSH. Normal ranges are 3.1-7.7 pmol/L.
Free T4- activated by
TSH. Normal ranges are 9-18 pmol/L.
Beta HCG- a hormonal
marker of pregnancy. Should be <5 U/L in non-pregnant pre-menopausal women,
and <9.5 U/L in post-
Prothrombin time (clotting). Normal ranges are 10-13 sec.
International normalized ratio (INR). Normal ranges are 0.8-1.2.
Amylase- an enzyme
involved in breaking down of starch. Increase levels indicate a variety of
digestive problems, most commonly pancreas inflammation and ulcers. Normal
ranges are 30-110 U/L.
Percentage of amylase that is Salivary by nature.
Percentage of amylase that is Pancreatic by nature. Pancreatic and Salivary
Amylase should add up to 100%
The Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS)
The Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS) is an instrument
for evaluating the functional status of patients with Amyotrophic Lateral
Sclerosis. It can be used to monitor functional change in a patient over time.
- cutting food and handling utensils (with or without gastrostomy)
- dressing and hygiene
- turning in bed and adjusting bed clothes
- climbing stairs
Concomitant Medication Use
Concomitant Medication Use lists the medications given to the patients during the trial that were not the primary drug being tested. These could be due to the patients other conditions, acute or chronic, that are not ALS, supplements favored by the patients or medication related to any adverse events form the treatment. Concomitant medications were not always recorded given to the database, therefore the lack of concomitant medication data is not enough to conclude that medications were not used. This can be seen in cases where patients are listed as Using Riluzole, but there is not Concomitant Medication Information about that use.
Information includes [Medication coded], and also [Dose], [unit], [Route] and [Frequency], as well as [Start Delta] and [Stop Delta] when such information was available.
Adverse events are all events recorded in the patients’ clinical records during the trial, form bruises and headaches to stroke. These events may or may not be related to the treatment at hand. Information about the events is given in a hierarchical fashion, from the actual medical record [lower_Level_Term] to the group category that describes it ([Preferred_Term] is the direct matched, followed by [High_level_term], [High_Level_Group_Term] and [System_Organ_Class].
Also, when available, the severity [Severity] and outcome [Outcome] of the adverse event is also listed, as well as its start time [Start_Date_Delta] and end time [End_Date_Delta].