This page shows what was measured, who it was measured in, and what that does not settle.
What Filgrastim does in the body
Rebuilding infection-fighting white cells knocked down by chemotherapy
Your bone marrow has a standing production line for neutrophils, the white cells that handle bacteria first. Chemotherapy shuts the line down for about a week. Filgrastim is a copy of the hormone that tells the line to run faster and to release its finished stock early. It does not protect the marrow from the chemotherapy; it shortens the gap afterwards.
What happened in people
Febrile neutropenia in small cell lung cancer: 77% of patients on placebo versus 40% on G-CSF
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The recorded finding that sits closest to something a person would notice. Written into the record, not signed off, and it carries no population or interval.
That the early mortality benefit equals an overall survival benefit — the meta-analysis states the data are insufficient to say
Where it acts
Neutrophil progenitors in the bone marrow
Kind of result
The kind of result is not recorded
Supervision
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.
What the registries record it as
The substance registry classes this as protein.
FDA substance registry · PVI5M0M1GW · read 2026-08-29
Where each sentence above came from
No recorded sentence describes the change this makes in a way that stands on its own. The page opens with what it is taken for instead, and the recorded explanation follows below.
Shown as the opening line on this page.
A limit recorded against this substance. Not signed off as a reviewed claim.
The four opening statements run to 87 words.
Words this page uses
Four words worth knowing first
Chosen from what this page shows, with each one explained before the word it depends on.
Absolute difference
An absolute difference is how many more people in a hundred were affected.
A picture of it, and where the picture fails
It is like counting heads in two rooms of a hundred.
Where that stops being true. Heads are easy to count. Study results carry a margin of error too.
What people get wrong. It is confused with a percentage change, which can look far larger.
The arithmetic difference in event rates between arms.
Confidence interval
A confidence interval is the range the true answer is likely to sit in.
A picture of it, and where the picture fails
It is like a weather forecast giving a range rather than one number.
Where that stops being true. A forecast range covers tomorrow. This one covers what the study could resolve.
What people get wrong. The middle number is read as the answer. A range crossing zero means no change is still possible.
An interval estimate that would contain the true parameter in a stated proportion of repeated studies.
What happened in people◇Read from sources, not yet reviewed
What happened in people
Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.
Incidence of fever with neutropenia across up to six chemotherapy cycles
✓ The study showed what it set out to show
Who was studied
Crawford 1991 small cell lung cancer trial (predates ClinicalTrials.gov registration)
How many people
211
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
p < 0.001 (77% versus 40% of patients)
Repeated elsewhere
Replicated
What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.
The limits of this study, and where it came from
Main limit. Medullary bone pain in 20% of treated patients is in the paper but is routinely omitted from summaries of this trial.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Subcutaneous or intravenous injection, single-dose vials and prefilled syringes
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
NEUPOGEN (filgrastim) injection — US prescribing information, DailyMed (https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=97cc73cc-b5b7-458a-a933-77b0… · a recorded source, not a stored snapshot
Febrile neutropenia, infection-related mortality and early all-cause mortality
✓ The study showed what it set out to show
Who was studied
Kuderer 2007 meta-analysis (17 pooled randomised trials)
How many people
3493
Study design
Systematic review of Phase 3 trials
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
p = 0.002 for early all-cause mortality (relative risk 0.60, 95% CI 0.43-0.83)
Repeated elsewhere
Replicated
What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Subcutaneous or intravenous injection, single-dose vials and prefilled syringes
Interval reported. 95% CI 0
Written into the record, not signed off as a reviewed claim.
NEUPOGEN (filgrastim) injection — US prescribing information, DailyMed (https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=97cc73cc-b5b7-458a-a933-77b0… · a recorded source, not a stored snapshot
Acute myeloid leukaemia or myelodysplastic syndrome, and overall mortality
✓ The study showed what it set out to show
Who was studied
Lyman 2010 secondary malignancy meta-analysis (25 pooled randomised trials)
How many people
12804
Study design
Systematic review of Phase 3 trials
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
p = 0.007 for AML/MDS (relative risk 1.92); p < 0.001 for mortality (relative risk 0.897)
Repeated elsewhere
Replicated
What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Subcutaneous or intravenous injection, single-dose vials and prefilled syringes
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
NEUPOGEN (filgrastim) injection — US prescribing information, DailyMed (https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=97cc73cc-b5b7-458a-a933-77b0… · a recorded source, not a stored snapshot
What we know
RNAWiki holds 3 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.
What it changes in the body◇Read from sources, not yet reviewed
The path through the body
From what a person takes to what changes. A solid line is a step measured in people. A dashed line is a step nobody has measured that way.
Start
Filgrastim
What a person takes: Subcutaneous or intravenous injection, single-dose vials and prefilled syringes.
The measurement behind this step
Clear, colourless, preservative-free solution at pH 4.0. Supplied as 300 mcg/mL and 480 mcg/1.6 mL vials, and as 300 mcg/0.5 mL and 480 mcg/0.8 mL prefilled syringes. The acidic formulation is required for stability and is the reason injection can sting.
Getting in
Injected under the skin or into a vein
A daily injection, usually starting a day or so after the chemotherapy has finished and continuing until the white count has recovered.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
Non-glycosylated, so cleared by both renal filtration and neutrophil-mediated internalisation. Half-life is roughly three to four hours, which is why daily dosing is needed and why the PEGylated version exists.
It circulates to the bone marrow, where the immature cells destined to become neutrophils are waiting.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
Distributes to G-CSFR-bearing cells: granulocyte-macrophage and granulocyte colony-forming units, promyelocytes, myelocytes and mature neutrophils. Receptor density rises with maturation, which is what makes the clearance mechanism self-limiting.
Two copies of the drug and two receptors lock together into a single signalling unit on the cell surface.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
The four-helix bundle engages the immunoglobulin-like and cytokine receptor homology domains of G-CSFR, forming a 2:2 cross-over complex. Receptor dimerisation is obligatory: monomeric occupancy does not signal.
The receptor turns on the internal machinery that tells the cell to divide, mature and stay alive.
──Measured in people. Written by a person from the study named beside the step. Not signed off as a reviewed claim.
The measurement behind this step
Receptor-associated JAK1 and JAK2 phosphorylate the cytoplasmic tail, recruiting STAT3 and STAT5. STAT3 drives proliferation and granulocytic differentiation; the SHP-2 and Ras-MAPK arms contribute to survival. Truncating CSF3R mutations that remove the negative-regulatory domain are found in severe congenital neutropenia patients who progress to leukaemia, which is the mechanistic thread behind the secondary malignancy signal.
Mature neutrophils are released early from the marrow reserve
Cells that would have sat in the marrow for days are pushed out into the blood now, and the production line behind them runs faster.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
Neutrophil elastase and cathepsin G released by expanding granulocytes cleave marrow CXCL12, breaking the CXCR4 retention signal that holds neutrophils in the marrow niche. This is also the mechanism exploited for peripheral blood stem cell mobilisation.
The nadir is shorter, and fewer people get febrile
The measurable result is fewer days with a dangerously low count, and about half as many patients developing fever during them.
──Measured in people. Written by a person from the study named beside the step. Not signed off as a reviewed claim.
The measurement behind this step
Median grade IV neutropenia duration fell from six days to one in the registration trial, with febrile neutropenia dropping from 77% to 40% of patients and an approximately 50% reduction in intravenous antibiotic days, hospital days and confirmed infections.
No suggested links are held for this record, so nothing is hidden from this path.
What we know
The record describes 6 steps from taking it to an effect in a person.
How we know it
Each step names the study behind it in the technical detail beside it.
What this does not prove
A change inside the body is a reason to look. It is not a result in a person.
Why it matters
A reader can see exactly where the chain stops being measured in people.
What we still do not know
No reviewed claim binds any of these steps to a named population.
What is missing or unclear◇Read from sources, not yet reviewed
Were people like you studied?
RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.
Who was studied
People similar to this profile were included.
Patients on chemotherapy regimens with a high risk of febrile neutropenia, stem cell donors and autologous transplant patients being mobilised, and people with severe chronic neutropenia including congenital, cyclic and idiopathic forms.
Who is missing from the studies
Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What the label states about particular groups
On pediatric, the label states: “In a phase 3 study (Study 7) to assess the safety and efficacy of filgrastim in the treatment of SCN, 123 patients with a median age of 12 years (range 7 months to 76 years) were studied.”
US prescribing information · 89092bb8-6a20-e23e-e053-2a95a90aa750 · read 2026-08-30
On older people, the label states: “Among 855 subjects enrolled in 3 randomized, placebo-controlled trials of filgrastim treated-patients receiving myelosuppressive chemotherapy, there were 232 subjects age 65 or older, and 22 subjects age 75 or older.”
US prescribing information · 89092bb8-6a20-e23e-e053-2a95a90aa750 · read 2026-08-30
On people who are pregnant, the label states: “In animal reproduction studies, effects of filgrastim on prenatal development have been studied in rats and rabbits.”
US prescribing information · 89092bb8-6a20-e23e-e053-2a95a90aa750 · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary There is published literature documenting transfer of filgrastim into human milk.”
US prescribing information · 89092bb8-6a20-e23e-e053-2a95a90aa750 · read 2026-08-30
Where the result stopped carrying
Attempts to use G-CSF to intensify chemotherapy beyond standard dose have not consistently improved cure rates outside specific lymphoma and breast cancer regimens
The class carries an unresolved leukaemogenic signal that has never been separated from the dose intensity it enables
This is a scope explorer, not a diagnosis engine.
It shows who was studied so you can see whether people similar to you were included.
RNAWiki cannot tell whether a study fits you. It can show who was in it.
What it would be like to take◇Read from sources, not yet reviewed
Why it might seem to do nothing
A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.
It was studied in different people
The people in the studies were not much like the reader.
On this record: Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
The evidence may simply be wrong
Small early studies often do not hold up.
On this record: RNAWiki has not yet published a reviewed conclusion for this use.
Other reasons RNAWiki checked and found nothing for (11)
It was studied for a different goal
The studies measured something else entirely. Nothing in this record points to this reason.
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.
None of these is a reason to take more. Taking more is not a step this page ever suggests.
What it would be like to take◇Read from sources, not yet reviewed
What taking it involves
The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.
How it is supplied
Given by a clinician
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Read from the recorded approval status.
No source is stored against this line.
Form and route
Subcutaneous or intravenous injection, single-dose vials and prefilled syringes
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form and route recorded on this substance.
No source is stored against this line.
Who oversees it
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Suppression classes recorded: S1, S4.
No source is stored against this line.
What is in the pack
0. 8 mL prefilled syringes. The acidic formulation is required for stability and is the reason injection can sting.
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
Recorded notes on how this is sold and what that means for what is in the pack.
No source is stored against this line.
Where it is registered
Regulatory records are listed in the technical disclosure at the foot of this page.
# Counted from records
Where this came from
A count of rows RNAWiki holds. It describes our records, not your body.
Register entries are stored per jurisdiction and shown with their dates.
No source is stored against this line.
Why people stop
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
No record of why people stopped taking it is stored for this substance.
No source is stored against this line.
What it would be like to take◇Read from sources, not yet reviewed
What can go wrong
Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.
·Worth asking a clinician aboutWritten into the record from the studies named on this page
Splenic rupture, acute respiratory distress syndrome, serious allergic reactions, sickle cell crisis, glomerulonephritis, capillary leak syndrome, thrombocytopenia and cutaneous vasculitis are all labelled risks. Bone pain affects roughly one in five. In severe chronic neutropenia the label requires monitoring for myelodysplastic syndrome and acute myeloid leukaemia.
Nobody counted how many people took this and were fine, so this cannot be turned into a rate.
Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.
Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What is missing or unclear◇Read from sources, not yet reviewed
Does the exact form matter?
Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.
The form that was studied
Subcutaneous or intravenous injection, single-dose vials and prefilled syringes
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form used in the studies cited on this page.
No source is stored against this line.
What is sold
0. 8 mL prefilled syringes. The acidic formulation is required for stability and is the reason injection can sting.
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
Recorded notes on which forms are sold and how they compare.
No source is stored against this line.
What is recorded as being sold
26 products list this as an active ingredient in the United States drug directory. 26 of them contain it and nothing else.
FDA National Drug Code directory · 63459-910 · read 2026-08-29
They are sold as injection, injection, solution and liquid, taken intravenous and subcutaneous.
FDA National Drug Code directory · 63459-910 · read 2026-08-29
The regulator's established pharmacologic class for it is granulocyte colony-stimulating factor [cs], increased myeloid cell production [pe] and leukocyte growth factor [epc].
FDA National Drug Code directory · 63459-910 · read 2026-08-29
8 published labels name it as an active ingredient. 8 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · 89092bb8-6a20-e23e-e053-2a95a90aa750 · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · 89092bb8-6a20-e23e-e053-2a95a90aa750 · read 2026-08-29
NYPOZI txid is intravenous at 3 DOSAGE FORMS AND STRENGTHS NYPOZI is a clear, colorless to slightly yellowish, preservative-free solution available as: Prefilled syringe: Injection: 300 mcg/0.5 mL in a single-dose prefilled syringe with BD UltraSafe…, recorded as fda label in effect 2026-01-15 in the United States.
US prescribing information · 89092bb8-6a20-e23e-e053-2a95a90aa750 · read 2026-08-30
Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.
What it would be like to take◇Read from sources, not yet reviewed
What you could measure
This one is decided with a clinician, so this section holds questions to ask rather than a plan to run.
Self-experiment planning is not offered for a prescription or clinician-supervised medicine. The questions below are for a clinician or pharmacist.
Questions worth asking
Which of the trials of Filgrastim studied people like me?
What was measured, and for how long?
Was the result a laboratory value or a health outcome?
What would we watch for, and when would we stop?
Tracking can show whether something changed for you. It cannot show what caused it.
RNAWiki records evidence. It does not say whether this substance is right for you.
What is missing or unclear◇Read from sources, not yet reviewed
Claims that go past the evidence
Things said about this substance that sound reasonable, and the exact step that is missing between the evidence and the claim.
✗Goes past the evidence
That the early mortality benefit equals an overall survival benefit — the meta-analysis states the data are insufficient to say
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
✗Goes past the evidence
That every chemotherapy regimen benefits; the guideline threshold of roughly 20% febrile neutropenia risk is a convention, not a trial result
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
✗Goes past the evidence
That bone pain is a marker of efficacy rather than a mechanical consequence of marrow expansion
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
What is missing or unclear◇Read from sources, not yet reviewed
What nobody knows yet
Open questions, each with why it is open and what would close it.
Missing populations
Which groups were under-represented in the studies has not been recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing long-term data
No completed tested study window is recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
No reviewed conclusion
RNAWiki has not yet published a reviewed conclusion for this use.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing interaction studies
No interaction was found in the registers checked. Not finding one is not the same as showing there is none.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Formulation uncertainty
Several salts, forms or products of Filgrastim are recorded. Results from one form may not transfer to another.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Mechanism not reviewed
No reviewed mechanism story exists for this substance.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
What happened in people◇Read from sources, not yet reviewed
Check any of this yourself
Every line above traced back to the study it came from. This is the technical layer, and the vocabulary changes here.
Every line above can be traced to the study named beside it. Follow the link and read it.
Registration trial: febrile neutropenia fell from 77% to 40%
In plain words
In 199 evaluable small cell lung cancer patients on identical chemotherapy, the proportion who had at least one episode of fever with a dangerously low white count fell by nearly half.
What was measured
77% versus 40% of patients with at least one febrile neutropenic episode (p < 0.001)
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Multicentre, randomised, double-blind, placebo-controlled trial of recombinant methionyl G-CSF across up to six cycles of cyclophosphamide, doxorubicin and etoposide. At least one episode of fever with neutropenia occurred in 77% of the placebo group versus 40% of the G-CSF group (p < 0.001). Median duration of grade IV neutropenia across all cycles was six days with placebo and one day with G-CSF. Days on intravenous antibiotics, days in hospital and confirmed infections each fell by approximately 50%. Mild to moderate medullary bone pain occurred in 20% of G-CSF recipients.
Written into the record, not signed off as a reviewed claim
Pooled meta-analysis: early mortality fell 40%, infection mortality 45%
In plain words
Across seventeen randomised trials and 3,493 patients, prophylactic G-CSF reduced deaths during the chemotherapy period, not just fevers.
What was measured
Early all-cause mortality relative risk 0.60 (95% CI 0.43-0.83)
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Systematic review and meta-analysis of randomised trials of primary prophylactic G-CSF versus placebo or untreated control in adults with solid tumours or lymphoma. Infection-related mortality relative risk 0.55 (95% CI 0.33-0.90, p = 0.018). Early all-cause mortality during the chemotherapy period relative risk 0.60 (95% CI 0.43-0.83, p = 0.002). Febrile neutropenia relative risk 0.54 (95% CI 0.43-0.67, p < 0.001). Average relative dose intensity was significantly higher with G-CSF. Bone or musculoskeletal pain was reported in 19.6% of G-CSF patients versus 10.4% of controls.
Written into the record, not signed off as a reviewed claim
Overall survival was not the endpoint, and the same paper says so
In plain words
The mortality benefit measured is during the chemotherapy period. Whether patients live longer overall is a separate question the trials were not built to answer.
What was measured
That reducing febrile neutropenia and early mortality means patients live longer overall
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The 2007 meta-analysis concludes explicitly that there are insufficient data to assess the impact of G-CSF on disease-free and overall survival. The measured mortality outcomes are infection-related mortality and early all-cause mortality during the chemotherapy period. Long-term survival depends on whether the higher achieved dose intensity translates into better cancer control, which varies by tumour and regimen and has been demonstrated in only a subset of settings.
Written into the record, not signed off as a reviewed claim
A near doubling of secondary leukaemia risk, against a larger fall in all-cause mortality
In plain words
Following 12,804 randomised patients for a median of four and a half years, treatment-related leukaemia was about twice as common with G-CSF support. Death from any cause was less common.
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Systematic review of 25 randomised trials, 6,058 patients randomised to chemotherapy with initial G-CSF support and 6,746 without, at mean and median follow-up of 60 and 53 months. Acute myeloid leukaemia or myelodysplastic syndrome was reported in 43 G-CSF patients versus 22 controls: relative risk 1.92 (95% CI 1.19-3.07, p = 0.007), absolute risk increase 0.41% (95% CI 0.10-0.72, p = 0.009). Over the same trials all-cause mortality relative risk was 0.897 (95% CI 0.857-0.938, p < 0.001), an absolute reduction of 3.40%. The greater delivered dose intensity that G-CSF enables is the plausible mediator of both effects.
Written into the record, not signed off as a reviewed claim
The first US biosimilar of any kind was a filgrastim
In plain words
Zarxio, approved in March 2015, was the first product ever licensed under the US biosimilar pathway. This is one of the few biologic markets where competition genuinely moved the price.
What was measured
First US biosimilar approval: 6 March 2015
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Zarxio (filgrastim-sndz, BLA 125553) was approved 6 March 2015 as the first product licensed under section 351(k) of the Public Health Service Act. Nivestym (BLA 761080) followed in July 2018 and Releuko (BLA 761082) in February 2022. Filgrastim is a small, non-glycosylated, bacterially expressed protein with a well-characterised potency bioassay, which is exactly the profile that makes analytical comparability tractable, and it is why this class became the proving ground for the pathway rather than a monoclonal antibody.
Source
Drugs@FDA, BLA 125553 (Zarxio), BLA 761080 (Nivestym), BLA 761082 (Releuko)
Role in the trial
Not matched to a registered study
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verified
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Written into the record, not signed off as a reviewed claim
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2 documents were read for this substance.
RNAWiki source record
2 of them state the same halfLife, and they agree.
RNAWiki source record
2 of them state the same bioavailability, and they agree.
RNAWiki source record
Where else this substance is registered
FDA substance identifier (UNII)
PVI5M0M1GW
RxNorm concept
727535
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No registered study is classified as testing this substance.
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Suppression classes recorded: S1, S4.
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How this medicine reached us
Kept near the foot of the page. A historical event moves up only when it changes something about this substance today.
What the approval register records
1 approved application covers products containing this substance. The earliest was BLA103353, approved 19910220 to AMGEN.
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7 questions this page could not answer
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A non-glycosylated bacterial copy of the human neutrophil growth factor with one extra methionine; in the registration trial it cut febrile neutropenia in small cell lung cancer from 77% of patients to 40%, and it shortened grade IV neutropenia from a median six days to one.
Recorded evidence blocks (10)
Q2
On the Filgrastim label: indicated for what?
"NEUPOGEN is a leukocyte growth factor indicated to Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever ( 1.1 ) Reduce the time to…": indications and usage on Filgrastim's label. DailyMed label · 97cc73cc-b5b7-458a-a933-77b00523e193 · 2026-07-23
Q3
1011 registered trials of Filgrastim — at which phases?
Registered studies posting no result
698 of 1011
1011 registered studies of Filgrastim: 602 phase2, 295 phase1, 165 phase3, 41 na, 21 phase4, 11 early phase1, 10 na or unstated. CLINICALTRIALS_SNAPSHOT · 2026-09-01
"PI left institution"; 140 of 1011 registered studies
Show the evidence
Trial
NCT00002761
withdrawn; "PI left institution"
NCT00002772
terminated; "poor accrual"
NCT00003060
terminated; "lack of patient accrual"
NCT00003086
terminated; "no participants enrolled in a three year period"
NCT00003152
terminated; "low accrual"
NCT00003194
terminated; "Study enrollment did not meet expected goals"
14 further recorded trials
NCT00003567
terminated; "slow accrual"
NCT00003640
terminated; "low accrual"
NCT00003852
terminated; "lack of patient inclusion"
NCT00003926
terminated; "Withdrawn due to slow accrual"
NCT00004114
withdrawn; "Study never opened"
NCT00005612
terminated; "Low accrual"
NCT00005787
terminated; "Per PI due to poor/inadequate accrual."
NCT00005834
terminated; "poor accrual"
NCT00005852
terminated; "low accrual"
NCT00005984
terminated; "Study terminated as principal investigator \[PI\] left the university."
NCT00005986
terminated; "Principal investigator left the university."
NCT00005987
terminated; "Withdrawn because treatment guidelines changed"
NCT00005998
withdrawn; "Withdrawn because study never enrolled patients"
NCT00006374
withdrawn; "Slow accrual"
recorded 2026-09-01 · last checked 2026-09-04
Q5
Human studies of Filgrastim used pegfilgrastim 12 mg — over how long?
studies of Filgrastim used the recorded amount. ClinicalTrials.gov · 2026-09-01
4 recorded entries; human; also "pegfilgrastim 12 mg", "pegfilgrastim 6 mg", "Filgrastim (75mcg/0.3ml)"
Show the evidence
human
NCT00066092
pegfilgrastim 12 mg
NCT00066092
pegfilgrastim 6 mg
NCT03656042
Filgrastim (75mcg/0.3ml)
NCT03892421
Filgrastim 0.3 MG/ML
recorded 2026-09-01 · last checked 2026-09-04
Q6
Filgrastim's half-life is 3.5 hours — which schedules were studied?
3.5 hours, the half-life Filgrastim's label states: "After intravenous administration, the volume of distribution averaged 150 mL/kg and the elimination half-life was approximately 3.5 hours in both normal subjects and cancer subjects." DailyMed label · 97cc73cc-b5b7-458a-a933-77b00523e193 · 2026-07-23
bioavailability 60 %.
Show the evidence
half lifepharmacokinetics
3.5 hours; After intravenous administration, the volume of distribution averaged 150 mL/kg and the elimination half-life was approximately 3.5 hours in both normal subjects and cancer subjects.
bioavailabilitypharmacokinetics
60 %; The absolute bioavailability of filgrastim after subcutaneous administration is 60% to 70%.
metabolismclinical_pharmacology
G-CSF regulates the production of neutrophils within the bone marrow and affects neutrophil progenitor proliferation, differentiation, and selected end-cell functions (including enhanced phagocytic ability, priming of the cellular metabolism associated with respiratory burst, antibody-dependent killing, and the increased expression of some cell surface antigens).
recorded 2026-07-23 · last checked 2026-09-04
Q7
Which running trial of Filgrastim could settle lifespan?
NCT01704716 measures Event Free Survival (R1: MAT therapy), reading out 2026-09.
16 open trials; n 3300; "High Risk Neuroblastoma Study 1.8 of SIOP-Europe (SIOPEN)"
Show the evidence
Trial
NCT01704716
"High Risk Neuroblastoma Study 1.8 of SIOP-Europe (SIOPEN)"; n 3300; "Event Free Survival (R1: MAT therapy)"; 2026-09
NCT04759586
"Nivolumab in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma"; n 244; "Progression-free survival (PFS)"; 2026-12-31
NCT00792948
"Combination Chemotherapy With or Without Donor Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia"; n 97; "Relapse-free Survival (RFS) After Allogeneic Stem Cell Transplantation"; 2027-01-06
NCT03907488
"Immunotherapy (Nivolumab or Brentuximab Vedotin) Plus Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage III-IV Classic Hodgkin Lymphoma"; n 994; "Progression Free Survival (PFS)"; 2027-03-28
NCT03125642
"Auto Stem Cell Transplant for Lymphoma Patients"; n 150; "Progression Free Survival Comparison"; 2027-04-30
NCT03007147
"Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia"; n 352; "Disease free survival (DFS) of Randomized Arms (standard risk [SR] Philadelphia chromosome [Ph+] acute lymphoblastic leukemia [ALL] patients)"; 2027-08-14
10 further recorded trials
NCT05436418
"The Lowest Effective Dose of Post-Transplantation Cyclophosphamide in Combination With Sirolimus and Mycophenolate Mofetil as Graft-Versus-Host Disease Prophylaxis After Reduced Intensity Conditioning and Peripheral Blood Stem Cell Transplantation"; n 260; "Phase II: Evaluate the efficacy of PTCy, at the lowest dose determined for each HLA-matching arm from phase I, as assessed by 1-year GVHD-free relapse-free survival (GRFS) rate."; 2028-06-25
NCT06928662
"Chemotherapy (Decitabine in Combination With FLAG-Ida) and Total-Body Irradiation Followed by Donor Stem Cell Transplant for the Treatment of Adults With Myeloid Malignancies at High Risk of Relapse"; n 36; "Non-relapse mortality (Phase 1)"; 2028-11-29
NCT06188676
"Multicenter Study of Safety and Efficacy Nivolumab at the Fixed Dose 40 mg (Nivo40) in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed PMBL"; n 100; "Progression-free survival (PFS)"; 2029-04-01
NCT02582697
"Accelerated v's Standard BEP Chemotherapy for Patients With Intermediate and Poor-risk Metastatic Germ Cell Tumours"; n 500; "Progression-free survival (disease progression or death)"; 2029-12-31
NCT01871766
"Risk-Adapted Focal Proton Beam Radiation and/or Surgery in Patients With Low, Intermediate and High Risk Rhabdomyosarcoma Receiving Standard or Intensified Chemotherapy"; n 115; "Event-free survival (intermediate risk arm)"; 2030-06
NCT02015013
"Hematopoietic Stem Cell Mobilization in Idiopathic CD4 Lymphocytopenia Patients and Healthy Controls for the Study of T Cell Maturation and Trafficking in Murine Models"; n 40; "To mobilize CD34+ HPCs in ICL patients and healthy volunteers for collection and transfer into immunocompromised mice to investigate thymic development, survival, and trafficking of these cells in murine lymphoid and non-lymphoid organs"; 2030-10-31
NCT07052370
"TCRαβ-depleted Progenitor Cell Graft With Early Memory T-cell DLI, Plus Selected Use of Blinatumomab, in naïve T-cell Depleted Haploidentical Donor Hematopoietic Cell Transplantation for Hematologic Malignancies"; n 30; "Number of participants experiencing grade 3-4 GVHD and/or transplant related mortality (TRM)."; 2030-12
NCT04685616
"Brentuximab Vedotin in Early Stage Hodgkin Lymphoma"; n 1042; "Progression free survival (PFS)"; 2032-09
NCT05535166
"Molecular and Clinical Risk-Directed Therapy for Infants and Young Children With Newly Diagnosed Medulloblastoma"; n 130; "Progression free survival of SHH-2 infant (0-2.99 years) and young child (3-4.99 years) medulloblastoma patients treated with systemic HD-MTX-based chemotherapy only."; 2035-07
NCT07616154
"Haploidentical Donor Hematopoietic Cell Transplant for Sickle Cell Disease"; n 45; "GVHD-free and rejection free survival (GRFS)"; 2035-09
Q8
Which 371 trials of Filgrastim posted no result?
Posted no result
371 of 371 completed trials
Registrations
NCT00002461, NCT00002526, NCT00001048, NCT00000801, NCT00001059 and NCT01713309, and 365 more
Completion dates
oldest 1991-07; newest 2024-05-24
Show the evidence
Trial
NCT00002461
1991-07
NCT00002526
1995-09
NCT00001048
1997-04
NCT00000801
1998-04
NCT00001059
1998-08
NCT01713309
1998-09
14 further recorded trials
NCT00001071
1998-10
NCT00000626
1999-02
NCT00002755
1999-06
NCT00002674
2000-03
NCT00003400
2000-03
NCT00003776
2000-03
NCT00002635
2000-04
NCT00003398
2000-05
NCT00002691
2000-06
NCT00004904
2000-07
NCT00004215
2000-08
NCT00019474
2000-08
NCT00006241
2000-10
NCT00002567
2000-11
Q9
At the median, Filgrastim's trials enrolled 40 people — anything larger?
Median enrolment
40
Largest enrolment
60000
Registered trials counted
907
Q10
What do 33066 spontaneous reports say about Filgrastim — and not say?
These are reports people sent to a regulator. They do not show the medicine caused the reaction. Nobody counted how many people took the medicine and reported nothing. The same event can be reported more than once, and many reports are incomplete. News coverage, lawsuits and new warnings change how often people report. A count is not a rate and not a risk.
Filgrastim appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 33066 reaction mentions were counted: wrong technique in product usage process 7895; unintentional medical device removal 6546; device adhesion issue 5341; device use error 4867. FAERS via Open Targets · CHEMBL1201567 · 2026-06-24
Show the evidence
wrong technique in product usage process
7895
unintentional medical device removal
6546
device adhesion issue
5341
device use error
4867
febrile neutropenia
2326
bone pain
1761
4 more recorded rows
neutropenia
1733
application site haemorrhage
1049
application site pain
792
occupational exposure to product
756
recorded 2026-06-24 · last checked 2026-09-04
Q11
Which 10 reactions does Filgrastim's label not list?
ChEMBL 37 — CC BY-SA 3.0 Unported · ChEMBL ATC CC BY-SA · ClinicalTrials.gov — US Government work · Open Targets 26.06 — CC0 · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work
✗ required summary fields resolved: 4 required field(s) not terminal: Why people use it, Best-supported result, Biggest unanswered question, Human evidence
✓ public claims reviewed: 0 reviewed claim(s); drafts are never rendered
✓ source coverage passed: 6 source rows
✓ no critical contamination: no quarantine open
✓ canonical metadata passed: slug and display name present
✓ no raw internal fields: enforced by the copy-contract test over the rendered page
This is a record of evidence. It is not medical advice, and it does not say this substance suits you. Nothing here says any substance on RNAWiki is appropriate for a child.