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Welcome to the
Pooled Resource Open-Access ALS Clinical Trials Database
How to Use PRO-ACT

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.

Basic 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 diagnosis.

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 ALS progression.

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:

  • ALSFRS(R)
  • Death Report
  • Demographics
  • 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:

SubjectID FormID Demographics Delta Ethnicity Sex Race - Black/ African American Race - Caucasian Age
329 144 0   Female 1   38

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 different days.

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].

Demographics
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 signs
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 minute)]

Lab data
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:
Urine pH- the level of acidity of the urine. Levels range between 4.5 to 8 (optimal is 6).
Urine Protein- 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 .
Urine Specific Gravity- (sometimes listed as Specific gravity) relates to the degree of concentration of the urine, indicative of kidney function. Normal ranges are 1-1.03.
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).
Urine Leukoesterase- 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 value).

Blood
Blood proteins:
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.
Electrolytes: Measured in an electrolyte panel to assess electrolyte levels found in disease and nutritional imbalances. The concentrations of sodium and potassium are tightly regulated by the body, as is the balance among sodium, potassium, chloride, and bicarbonate. Electrolyte (and acid-base) imbalances can be present with a wide variety of acute and chronic illnesses. Both increases and decreases can be significant.
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).
Potassium- Normal ranges are 3.5 - 5.4 mmol/L (note that values are sometimes high beyond reasonable range).
Bicarbonate (CO2)- Associated also with acid-base (pH) imbalance. Normal ranges are 18 - 23 mmol/L.
Chloride- Associated 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.
Magnesium- measures to assess to likelihood of magnesium, poisoning. Normal ranges are or 0.6-0.82 mmol/L.
Kidney Tests: BUN and creatinine are waste products filtered out of the blood by the kidneys. Increased concentrations in the blood may indicate a temporary or chronic decrease in kidney function.
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.
Creatinine- normal ranges are 53-106 mmol/L for males. Normal BUN/ Creatinine ratios are 5-35.(note that values are sometimes high beyond reasonable range).
Liver Tests: ALP, ALT, GGT and AST are enzymes found in the liver and other tissues. Bilirubin is a waste product produced by the liver as it breaks down and recycles aged red blood cells. All can be found in elevated concentrations in the blood with liver disease or dysfunction.
Alkaline phosphatase (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 numerical value).
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).
Gamma-glutamyltransferase-(GGT)- 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).
Complete blood count: used as a broad screening test to check for such disorders as anemia, infection, and many other diseases.
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 *109/L cells.
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:
Neutrophils- also 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 numerical value.
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 numerical value.
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.
Eosinophils- are 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.
Basophils- normally 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 sickle-cell anemia.
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%).
Mean Corpuscular 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%.
Mean Corpuscular Volume- Average red blood cell volume. Normal levels are 80-99 fL.
Mean Corpuscular 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 range).
Transferrin iron-binding 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
Heart disease and muscle degradation
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).
Triglycerides- 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).
Total Cholesterol- 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.
Lactate dehydrogenase- an enzyme involved in tissue breakdown, most commonly heart muscle damage, but also other tissues. Normal ranges are 50-150 U/L.
Blood sugar
Glucose-level of 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).
HbA1c (Glycated 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).
Mineral balance
Calcium- routine 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).
Phosphorus –related 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)
Immune response
Hepatitis - A,B,C antigen and antibody. Positive antibody levels indicate vaccination. Positive antigen levels indicate that the person is more infectious.
Immunoglobulins (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.
Hormones
TSH (Thyroid 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-menopausal women.
Coagulation measures
Prothrombin time (clotting). Normal ranges are 10-13 sec.
International normalized ratio (INR). Normal ranges are 0.8-1.2.
Others
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.
Salivary Amylase- Percentage of amylase that is Salivary by nature.
Pancreatic Amylase- 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)

Overview:
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.
Measures:
  1. speech
  2. salivation
  3. swallowing
  4. handwriting
  5. cutting food and handling utensils (with or without gastrostomy)
  6. dressing and hygiene
  7. turning in bed and adjusting bed clothes
  8. walking
  9. climbing stairs
  10. breathing

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
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].

3/3/2015 8:14:53 PM
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