Microsoft word - phuse2007_po07_riten_download

%RiTEN - PhUSE 2007 Poster 07 Download

02:59 Sat urday, Januar y 22, 2011 1
These are samples of what %RiTEN can do. Note %RiTEN can do these in different table styles and attributes as explained in the paper. Copyright 2007 Duong Tran. All rights reserved. %RiTEN - PhUSE 2007 Poster 07 Download

02:59 Sat urday, Januar y 22, 2011 2
Table 001-01 Using RTF Control Words to Span
Header Line
Program: t_span_header_line1.sas Output: t_span_header_line_001_01.rtf (Date Generated: 31JUL07:14:55:06) Source Data: class.sas7bdat Copyright 2007 Duong Tran. All rights reserved. %RiTEN - PhUSE 2007 Poster 07 Download

02:59 Sat urday, Januar y 22, 2011 3
Table 001-02 Using #byval in Title Statement
Program: t_hash_byval1.sas Output: t_hash_byval_001_02.rtf (Date Generated: 31JUL07:14:55:06) Source Data: class.sas7bdat Copyright 2007 Duong Tran. All rights reserved. %RiTEN - PhUSE 2007 Poster 07 Download

02:59 Sat urday, Januar y 22, 2011 4
Table 002-01 Framing Cells
Program: t_frame_cells1.sas Output: t_frame_cells_002_01.rtf (Date Generated: 31JUL07:14:55:07) Source Data: class.sas7bdat Copyright 2007 Duong Tran. All rights reserved. %RiTEN - PhUSE 2007 Poster 07 Download

02:59 Sat urday, Januar y 22, 2011 5
Table 002-02 Framing Cells
Program: t_frame_cells2.sas Output: t_frame_cells_002_02.rtf (Date Generated: 31JUL07:14:55:08) Source Data: class.sas7bdat Table 002-03 Cells Merging
Note the Treatment Difference lies between the treatments. Program: t_cells_merging1.sas Output: t_cells_merging_002_03.rtf (Date Generated: 31JUL07:14:55:09) Source Data: dummy.sas7bdat Copyright 2007 Duong Tran. All rights reserved. %RiTEN - PhUSE 2007 Poster 07 Download

02:59 Sat urday, Januar y 22, 2011 6
Table 003-01 Patient Profile
Program: t_patient_profile1.sas Output: t_patient_profile_003_01.rtf (Date Generated: 31JUL07:14:55:10) Source Data: class.sas7bdat Table 003-02 Patient Profile

ref no
This is a very very long text
Program: t_patient_profile2.sas Output: t_patient_profile_003_02.rtf (Date Generated: 31JUL07:14:55:11) Source Data: class.sas7bdat Copyright 2007 Duong Tran. All rights reserved. %RiTEN - PhUSE 2007 Poster 07 Download

02:59 Sat urday, Januar y 22, 2011 7
Table 004-01 Stacking Tables

This act like a lid when all the tables are collapsed.

ref no
This is a very very long text
Note: SAS do not have 3 sided frame. This is done via post-processing. Tables have not been collapsed for demonstration purpose. Set tgap=0 in %RiTEN to do so. Program: t_stacking_tables1.sas Output: t_stacking_tables_004_01.rtf (Date Generated: 31JUL07:14:55:12) Source Data: dummy.sas7bdat Table 004-02 Stacking Tables
Program: t_stacking_tables2.sas Output: t_stacking_tables_004_02.rtf (Date Generated: 31JUL07:14:55:13) Source Data: dummy.sas7bdat Copyright 2007 Duong Tran. All rights reserved. %RiTEN - PhUSE 2007 Poster 07 Download

02:59 Sat urday, Januar y 22, 2011 8
Table 004-03 Stacking Tables

Summary:
Program: t_stacking_tables3.sas Output: t_stacking_tables_004_03.rtf (Date Generated: 31JUL07:14:55:14) Source Data: dummy.sas7bat Table 005-01 Stacking Block Label
Female - Note This Label Can Span The Whole Table Width Because We Are Stacking This Label Program: t_stack_block_label1.sas Output: t_stack_block_label_005_01.rtf (Date Generated: 31JUL07:15:08:07) Source Data: class.sas7bdat Copyright 2007 Duong Tran. All rights reserved. %RiTEN - PhUSE 2007 Poster 07 Download

02:59 Sat urday, Januar y 22, 2011 9
Listing 1.1 Subjects Narratives of Serious Adverse Events
(Dummy Data)
Injury, poisoning and procedural complications [Arteriovenous graft thrombosis] / Thrombosis Injury, poisoning and procedural complications [Arteriovenous graft thrombosis] / Thrombosis a Severity: 01=Mild, 02=Moderate, 03=Severe, 04=Life Threatening, 05=Fatal b Action Taken: 01=None, 02=Investigational product dose altered, 03=Medication taken, 04=Hospitalised, 05=Removed from study, 06=Investigational product discontinued, 07=Transfusion performed, 88=Other Program: l_ae_narrative_arisg.sas Output: l21_01_ae_narrative_arisg.rtf (Date Generated: 31JUL06:09:09:55) Source Data: ae.sas7bdat, aearisg.sas7bdat Copyright 2007 Duong Tran. All rights reserved. %RiTEN - PhUSE 2007 Poster 07 Download

02:59 Sat urday, Januar y 22, 2011 10
Listing 1.1 Subjects Narratives of Serious Adverse Events
(Dummy Data)

AER #UK3500, Arteriovenous graft thrombosis, 20JUL2000
Subject with chronic renal failure, hypotension following dialysis, a history of arteriovenous (AV) graft failure in the left arm and a history of recurrent
stenosis and thrombosis of the AV graft,placed in the right arm for dialysis, was hospitalised with thrombosis of the vascular access approximately 23
days after initial exposure to treatment drug. The event improved followingthrombectomy and treatment with low molecular weight heparin and
ticlopidine. Treatment with treatment drug was continued. The Investigator commented that the probable etiology was stenosis of the vein. A
percutaneous angioplasty was performed and the event resolved. Mild hypotension following dialysis was noted during hospitalisation.
TheInvestigator reported thrombosis of the vascular access moderate and stated that there was a reasonable possibility that the event may have been
caused by treatment drug. Enoxaparin was considered co-suspect. Additional information received on 06/Sep/2000: Itwas confirmed that the subject
only experienced an episode of mild hypotension after haemodialysis during hospitalisation, and no hypotension was detected post-operatively. Re-
stenosis of the venasubclavia and vena brachiocephalica resolved. The Investigator reported re-stenosis moderate and stated that there was no
reasonable possibility that the event may have been caused by the blindedstudy drug.
a Severity: 01=Mild, 02=Moderate, 03=Severe, 04=Life Threatening, 05=Fatal b Action Taken: 01=None, 02=Investigational product dose altered, 03=Medication taken, 04=Hospitalised, 05=Removed from study, 06=Investigational product discontinued, 07=Transfusion performed, 88=Other Program: l_ae_narrative_arisg.sas Output: l21_01_ae_narrative_arisg.rtf (Date Generated: 31JUL06:09:09:55) Source Data: ae.sas7bdat, aearisg.sas7bdat Copyright 2007 Duong Tran. All rights reserved. %RiTEN - PhUSE 2007 Poster 07 Download

02:59 Sat urday, Januar y 22, 2011 11
Listing 1.1 Subjects Narratives of Serious Adverse Events
(Dummy Data)

AER #UK7787, Arteriovenous fistula thrombosis, 11NOV2000
Subject with chronic renal failure requiring dialysis and a history of recurrent arteriovenous (AV) graft stenosis and thrombosis, was hospitalised due
to thrombosis of the vascular accessapproximately five months after initial exposure to treatment drug. The event improved. Treatment drug therapy
was continued. The Investigator reported vascular access thrombosis moderate, andstated that there was a reasonable possibility that the event may
have been caused by treatment drug. Additional information received on 12/Dec/2000: Phlebography, percutaneous transluminalangioplasty (PTA)
and radiodiagnostic tests confirmed diagnosis. Thrombectomy and PTA were performed, and low molecular weight heparin was administered for the
event. In the Investigator's opinion,previous cannulation and stenosis of the left descending subclavian vein was a risk factor for this event. The
Investigator reported the low haemoglobin values severe and stated that there was noreasonable possibility that the event may have been caused by
treatment drug.
a Severity: 01=Mild, 02=Moderate, 03=Severe, 04=Life Threatening, 05=Fatal b Action Taken: 01=None, 02=Investigational product dose altered, 03=Medication taken, 04=Hospitalised, 05=Removed from study, 06=Investigational product discontinued, 07=Transfusion performed, 88=Other Program: l_ae_narrative_arisg.sas Output: l21_01_ae_narrative_arisg.rtf (Date Generated: 31JUL06:09:09:55) Source Data: ae.sas7bdat, aearisg.sas7bdat Copyright 2007 Duong Tran. All rights reserved. %RiTEN - PhUSE 2007 Poster 07 Download

02:59 Sat urday, Januar y 22, 2011 12
Listing 1.1 Subjects Narratives of Serious Adverse Events
(Dummy Data)
Congenital, familial and genetic disorders [Spondylolisthesis] / Worsening of lumbago-
AER #UK9547, Back pain, 06SEP2000
Subject with history of olisthesis was hospitalised with lumbago approximately nineteen days after initial exposure to treatment drug. He was
administered intravenous guaifenesin, mesocain, sodiumand salicylicum. Apercutaneous transluminal angioplasty was performed eight days later.
Additional information received on 24/Aug/2000: The subject was observed for transient postoperative hypotension and re-thrombosis during
hospitalisation. Stenosis of central venous tract was considered to be a probable aetiology
a Severity: 01=Mild, 02=Moderate, 03=Severe, 04=Life Threatening, 05=Fatal b Action Taken: 01=None, 02=Investigational product dose altered, 03=Medication taken, 04=Hospitalised, 05=Removed from study, 06=Investigational product discontinued, 07=Transfusion performed, 88=Other Program: l_ae_narrative_arisg.sas Output: l21_01_ae_narrative_arisg.rtf (Date Generated: 31JUL06:09:09:55) Source Data: ae.sas7bdat, aearisg.sas7bdat Copyright 2007 Duong Tran. All rights reserved. %RiTEN - PhUSE 2007 Poster 07 Download

02:59 Sat urday, Januar y 22, 2011 13
Listing 1.1 Subjects Narratives of Serious Adverse Events
(Dummy Data)
Injury, poisoning and procedural complications [Arteriovenous fistula thrombosis] / Trombosis of
AER #UK9095, Arteriovenous graft thrombosis, 27OCT2000
Subject with chronic renal failure, on dialysis, developed a thrombosis of the radiocephalic arteriovenous shunt and was hospitalised four weeks later,
approximately nine weeks after initial exposureto treatment drug. Additional information wasreceived on 05/Aug/2000: Acute thrombosis was
diagnosed by physical examination and after six days X-ray phlebography reported re-stenosis of the vena subclavia and vena brachiocephalica. The
Investigator commented that the probable etiology was stenosis of the vein.
a Severity: 01=Mild, 02=Moderate, 03=Severe, 04=Life Threatening, 05=Fatal b Action Taken: 01=None, 02=Investigational product dose altered, 03=Medication taken, 04=Hospitalised, 05=Removed from study, 06=Investigational product discontinued, 07=Transfusion performed, 88=Other Program: l_ae_narrative_arisg.sas Output: l21_01_ae_narrative_arisg.rtf (Date Generated: 31JUL06:09:09:55) Source Data: ae.sas7bdat, aearisg.sas7bdat Copyright 2007 Duong Tran. All rights reserved. %RiTEN - PhUSE 2007 Poster 07 Download

02:59 Sat urday, Januar y 22, 2011 14
Listing 1.1 Subjects Narratives of Serious Adverse Events
(Dummy Data)

AER #UK9548, Cystitis haemorrhagic, 06AUG2000
Subject was hospitalised with bleeding from the cystis urinae approximately six weeks after initial exposure to treatment drug. A cystoureteroscopy
was performed and revealed haemorrhagic cystitis. A percutaneous angioplasty was performed and the event resolved. The Investigator reported
theshunt thrombosis moderate and stated that there was no reasonable possibility that the event may have been caused by treatment drug.
Treatment was started with ciprofloxacin. The event was resolving.
a Severity: 01=Mild, 02=Moderate, 03=Severe, 04=Life Threatening, 05=Fatal b Action Taken: 01=None, 02=Investigational product dose altered, 03=Medication taken, 04=Hospitalised, 05=Removed from study, 06=Investigational product discontinued, 07=Transfusion performed, 88=Other Program: l_ae_narrative_arisg.sas Output: l21_01_ae_narrative_arisg.rtf (Date Generated: 31JUL06:09:09:55) Source Data: ae.sas7bdat, aearisg.sas7bdat Copyright 2007 Duong Tran. All rights reserved. %RiTEN - PhUSE 2007 Poster 07 Download

02:59 Sat urday, Januar y 22, 2011 15
Listing 1.1 Subjects Narratives of Serious Adverse Events
(Dummy Data)
Surgical and medical procedures [Inguinal hernia a Severity: 01=Mild, 02=Moderate, 03=Severe, 04=Life Threatening, 05=Fatal b Action Taken: 01=None, 02=Investigational product dose altered, 03=Medication taken, 04=Hospitalised, 05=Removed from study, 06=Investigational product discontinued, 07=Transfusion performed, 88=Other Program: l_ae_narrative_arisg.sas Output: l21_01_ae_narrative_arisg.rtf (Date Generated: 31JUL06:09:09:55) Source Data: ae.sas7bdat, aearisg.sas7bdat Copyright 2007 Duong Tran. All rights reserved. %RiTEN - PhUSE 2007 Poster 07 Download

02:59 Sat urday, Januar y 22, 2011 16
Listing 1.1 Subjects Narratives of Serious Adverse Events
(Dummy Data)
Investigations [Haemoglobin decreased] / Low hb
AER #UK7050, Haemoglobin decreased, 05NOV2000
Subject with chronic kidney disease, on dialysis, and a history of gastric ulcer was hospitalised with low haemoglobin approximately one month after
initial exposure to treatment drug. An endoscopywas performed and ulcus ventriculi verified. Study drug was withdrawn eighteen days later. The event
resolved. The Investigator reported the haemorrhagic cystitis moderate and stated that there was no reasonable possibility that the event may have
been caused by treatment drug.
a Severity: 01=Mild, 02=Moderate, 03=Severe, 04=Life Threatening, 05=Fatal b Action Taken: 01=None, 02=Investigational product dose altered, 03=Medication taken, 04=Hospitalised, 05=Removed from study, 06=Investigational product discontinued, 07=Transfusion performed, 88=Other Program: l_ae_narrative_arisg.sas Output: l21_01_ae_narrative_arisg.rtf (Date Generated: 31JUL06:09:09:55) Source Data: ae.sas7bdat, aearisg.sas7bdat Copyright 2007 Duong Tran. All rights reserved.

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