FDA AERS Database

[0485c10]

I just posted that the deaths of people using Gilenya in the US, is rather high in the Gilenya forum. not known if gilenya is a cause yet. still under investigation.

I quickly ran the deaths from Tysabri, for those 2 quarters, as a comparison. Scooter noticed very "smart alec" that the deaths of people using tysabri go down to 0 for people over 60,(btw its the same as the death's of 20 year olds using Tysabri). Well i wanted to post a "smart-alec" reply that for Tysabri users, 60 must be the new 20's (for users of Tysabri)

but i also wanted to show off all the record keeping i have been doing for Tysabri-PML recorded in the FDA AERS Database since...get this 3rd Quarter of 2006.

so i will post it here, which is more appropriate than in Gilenya section. the jcv antibody test should bring these numbers down in the future.

FDA Tysabri-"suspected&reprted PML"
(unconfired just, reported. may or may not have ended up as confirmed PML?)

from 3rd quarter, 2006 to 2nd quarter of 2011

Total 206
males 82
females 176
unlisted gender 1

Age:
Teen.........1
20's.........24
30's.........65
40's.........97
50's.........61
60's.........23
70's...........1
unlisted....19

Highest age:72 Male (2nd Quarter 2011)
Lowest Age: 15 Female(2nd quarter 2011)

country:
australia 5
austria 2
belgium 5
canada 2
finland 1
france 19
germany 46
greece 3
iceland 1
ireland 2
italy 8
netherland 5
poland 1
portugal 2
romania 1
spain 9
sweden 4
saudia arabia 1
south africa 1
switzerland 2
UK 3
USA 127
unlisted 0

FDA AERS Deaths 61
(unconfirmed if Ty-PML was the cause?)

[Scooter24]

Not sure what you mean by smart alic, I was just saying as a soon to be 60 yr old male my chances get better for not dying from it or PML.

[0485c10]

I was teasing. it hadn't occured to me it meant all deaths, from all cause, which it does. i was more focusing on the number as an upper limit to the # of possible PML deaths.

[lindaincolorado]

0485c10, I am a bit confused by your #s of 127 USA There are around 75 cases of pml in the U S, what is this #of 127 ??

[0485c10]

These are reported not confirmed, the confirmed instances of PML are lower. I think of them as the worst case, knowing the official numbers will be better. but these come out before the official numbers. and there is still a half a year delay, so its not like there "real time" reports either...

[Scooter24]

MSAA web site has a good article on the JCV test and stats.

[0485c10]

This gets really complicated because there are multiple sources i look at that have their own time frame. But i have a master spreadsheet that I write what each is at each time frame so i can compare the #'s at that time frame.

Biogen is what i take as the answer...... so i compare the chev site & what the FDA unconfirmed reports to a biogen announcement of confirmed cases at that time.

the chev site has matched what biogen later announced 100%.

The fda unconfirmed reports have averaged 50% being confirmed. Earlier comparisons like in 2008, most were confirmed if reported. But later quarters have gone as low as 37%..

Biogen had announced there were a total of 159 confirmed PML at the end of the 3rd Quarter 2011.The total FDA unconfirmed was 319 at that time. So 50% were confirmed.

The next quarter the FDA will release, 4th Quarter of 2011, probably won't be until the 2nd quarter of 2012.

Biogen has already announced up until Jan 2012. I just go through this so i have a source if ever they decide not to announce....and whatever else i might see through the comparisons. Plus its fun to do, kind of like a NYTimes crossword puzzle.

%confirmed after being reported
(from 3rd Quarter of 2011 to 3rd Quarter of 2008)

43%,58%,44%,39%,37%,71%,65%,64%,100%,100%,50%,100%

I think the lower % are a sign that the touch program is working to identify any suspected PML, early. even when it doesn't turn out to be PML.

[soshime]

your record-keeping

1. thanks for doing it - it's great to see all that info in one place.
2. do they perchance have # of doses for each person (death) listed? that would be a handy factor as well. . .
perhaps a little scary tho.
but wanted to say thank you for your fact-finding.

- soshime

[Tinkerbell65]

045c10- First off, want to thank you for all of your research. Since my mind/interests don't lean that way, I'm grateful that someone else's does and that you're so willing to share. Maybe I missed it, but is there any info stating whether or not the participants were + or - to start with?

Also very happy to hear that 60's are the same as the old 20's. I'm not there yet, but I imagine I will be someday I know 40's are the new 30's so the differences between the ages is fast forwarding. Or fast backwarding. Or something.

[0485c10]

Tinkerbell, no they don't have a field for jcv status and i doubt they ever will because the database if for all drugs, its huge! They won't add a field for the jcv test, tysabri & ms for that matter is a very miniscule part of the database.

I still use what information i can get from it...i just hate being surprised! I'm a better at being worried than i am at responding to being blindsided.

soshime they have a field for start date, end date, duration and increments of duration, days, weeks, months, years...i monitored it through 2009,2010 and part of 2011 but there were so many data entry errors, i really couldn't trust it so i stopped monitoring it.....with your question i thought i should look at that again? They have the start date and event date of suspected pml--so maybe i will add something into my database for how long after starting before suspected PML? That dur and duration code never did work well.

So i did that. 10.58 years after starting tysabri is the latest suspected PML.

i have that info for the 3rd Quarter of 2011 and i will continue it going forward. While I was looking at adding the duration, one thing that has always frustrated me..is people who end up dying after PML do not do so conveniently in the same quarter-- like gilyna users do..i was always trying to find a way to keep track of this on a spread sheet.

People when they get PML, there is some pretty intensive medical treatment with many entries under that case number...and i was always trying to think of a way to somehow record this. I was shocked when i sorted it for Gienya, those people just die when they die, i'm not even certain they had time to finish their coffee? i'm much happier with tysabri.

With tysabri its rather a long process:..'LT'-Life Threatening, 'HO'-hospitalization, 'DS'-Disability. 'OT'- Other and finally 'DE'-death for those who do not survive. In the past i would keep track of all the different outcomes with a slash in between them..but i think i will just start keeping track of when they entered the database and the quarter of the death, so its some kind of survival time after PML for those that do not ultimately survive.

soshime, i had the tysabri duration for those that did die...and i quickly got an average for that,because you were interested in it. i am keeping track of start of tysabri until event recorded in the FDA Data base, not for just death but suspected PML.....I'll post all i got for 3rd quarter of 2011. In next reply this afternoon, a few things i need to do first.

[0485c10]

3rd quarter of 2011, AERS Database.

Warning Some Statistics on PML non survivors below. Avoid this response if you don't want to see that information.

3rd quarter of 2011, the FDA AERS Database Reported/suspected PML, I got 56 cases with 8 deaths. During the same period Biogen had confirmed 26 cases with 5 deaths.(3 deaths may have been from something other than PML & 30 cases of 'reported/suspected/unconfirmed' PML may not have turned out to be PML)

This quarter I also processed the years between starting Tysabri and the reported event of "suspected" PML.
This has some low number of less than 1 year, when it has been reported in multiple trustworthy medical journals that no cases of PML have occurred before 1 year for the treatment of MS, except for 1 person who had recently used an immune-suppresant.

I think the 3 cases of reported/suspected PML before 1 year means that even in the first year,the monitoring program is taken seriously. Even though there has never been any PML in the 1st year for someone who hasn't used an immune-suppresant...that would mean it hasn't happened yet! There will always be a first person and it looks as if they treat symptoms of possible PML just a seriously in the 1st year as every year after.

M 8
F48
Unlisted Age 0

Age:
Teens 0
20's 5
30's 11
40's 16
50's 12
60's 9
Unlisted Age 3
Highest Age 65F
Lowest Age 25M

Years of TY Use Before Reported Suspected PML:
0-1 (3)
1-2 (7)
2-3 (10)
3-4 (18)
4-5 (7)
5-6 (3)
7-8 (0)
8-9 (1) 8.75years
10-11 (1) 10.58 years
Unknown (6)

Austria 1
Canada 1
France 6
Germany 5
Greece 3
Isreal 1
Italy 5
Sweeden 1
Turkey 1
UK 3
USA 29

Deaths: 8 (Germany-1, USA-7)
Ages 43,48,53,57,63(3),64

Length Of Time between Initial Report and Entry of 'DE'(yyq 103=2010, 3rd Quarter)
0 Quarter(same) 2
1 Quarter 3
2 Quarter 2
1 Year 1
[103/113(1),111/113(2),112/113(3),113/113(2)]

Tysabri used prior to entry of DE:
(First Event-Start of TY)
range of 1.92 to 4.88 years
Average: 2.85 years