Non Serious Adverse Drug Reactions Report |
Start Date:2016-08-19 End Date:2016-08-20 |
Study :EMR700623-541 | Investigator :Fei Gong | Country of Investigator :China | SiteNo:C01 |
Subject No :C01-0001 | Subject Initials :TTW | DOB :05/13/1988 | Sex:Female | Race:Asian | Height:157cm | Weight:3050g |
First administration date of batch : | Batch number : |
Study Drug | Start Date | Dose | Change in Dose |
Gonal-f New Pen Stimulation Treatment | 05/16/2015 | 112.5 | |
Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
OHSS | 06/06/2015 | 06/15/2015 | | Related | Moderate |
Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
None(Othervalue:) | Not applicable | Concomitant procedure** | Resolved | | |
Event Description:Nausea, vomiting, yellow urine with less volume, chest pelvic effusion,ascites puncture 10-Jun-2015,2200ml;ascites puncture 15-Jun-2015,2900ml; |
Subject received concomitant medications: |
Does the subject have any relevant past or present medical conditions:Yes |
Condition | Start Date | Related to study condition | Ongoing |
Bilateral fallopian tube obstruction | 04/11/2014 | Not on treatment/medication | Ongoing |
Non Serious Adverse Drug Reactions Report |
Start Date:2016-08-19 End Date:2016-08-20 |
Study :EMR700623-541 | Investigator :Fei Gong | Country of Investigator :China | SiteNo:C01 |
Subject No :C01-0068 | Subject Initials :X-S | DOB :04/16/1989 | Sex:Female | Race:Asian | Height:160cm | Weight:2500g |
First administration date of batch : | Batch number : |
Study Drug | Start Date | Dose | Change in Dose |
Gonal-f New Pen Stimulation Treatment | 06/27/2015 | 150 | |
Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
OHSS | 07/23/2015 | 08/04/2015 | | Related | Severe |
Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
None(Othervalue:) | Not applicable | Concomitant procedure** | Resolved | | |
Event Description:Abdominal distension, Nausea, yellow urine with less volume, chest pelvic effusion,Ascites puncture 23Jul2015,1000ml; 27Jul2015,2100ml; 30Jul2015,2500ml; 04Aug2015,2000ml; |
Subject received concomitant medications: |
Does the subject have any relevant past or present medical conditions:Yes |
Condition | Start Date | Related to study condition | Ongoing |
The left Hydrosalpinx and adhesions,less patency.Right fallopian tube partially blocked | 03/22/2014 | Not on treatment/medication | Ongoing |
right fallopian tube resection because of Ectopic pregnancy | UK-Oct-2011 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
Start Date:2016-08-19 End Date:2016-08-20 |
Study :EMR700623-541 | Investigator :Fei Gong | Country of Investigator :China | SiteNo:C01 |
Subject No :C01-0158 | Subject Initials :T-Y | DOB :06/17/1983 | Sex:Female | Race:Asian | Height:163cm | Weight:3300g |
First administration date of batch : | Batch number : |
Study Drug | Start Date | Dose | Change in Dose |
Gonal-f New Pen Stimulation Treatment | 09/16/2015 | 112.5 | |
Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
OHSS | 10/12/2015 | 10/12/2015 | | Related | Moderate |
Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
None(Othervalue:) | Not applicable | Concomitant procedure** | Resolved | | |
Event Description:Abdominal distension, Nausea, yellow urine with less volume, chest pelvic effusion,ascites puncture 12-Oct-2015,2500ml |
Subject received concomitant medications: |
Does the subject have any relevant past or present medical conditions:Yes |
Condition | Start Date | Related to study condition | Ongoing |
right fallopian tube is less patency,left fallopian tube is obstruction | 06/04/2015 | Not on treatment/medication | Ongoing |
Endometrial polyps hyperplasia | 08/24/2015 | Not on treatment/medication | Ongoing |
Non Serious Adverse Drug Reactions Report |
Start Date:2016-08-19 End Date:2016-08-20 |
Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
Subject No :C02-0002 | Subject Initials :LLL | DOB :02/12/1987 | Sex:Female | Race:Asian | Height:158cm | Weight:50.0kg |
First administration date of batch : | Batch number : |
Study Drug | Start Date | Dose | Change in Dose |
Gonal-f New Pen Stimulation Treatment | 05/08/2015 | 150 | |
Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
OHSS | 05/25/2015 | 06/03/2015 | | Related | Moderate |
Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
Event Description:Moderate OHSS patients, improved canceled after embryo transfer. |
Subject received concomitant medications: |
Does the subject have any relevant past or present medical conditions:Yes |
Condition | Start Date | Related to study condition | Ongoing |
salpingemphrxis,lalace peritoneoscope | Uk-Jul-2014 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
Start Date:2016-08-19 End Date:2016-08-20 |
Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
Subject No :C02-0118 | Subject Initials :MLF | DOB :08/03/1984 | Sex:Female | Race:Asian | Height:160cm | Weight:55.0kg |
First administration date of batch : | Batch number : |
Study Drug | Start Date | Dose | Change in Dose |
Gonal-f New Pen Stimulation Treatment | 05/21/2015 | 150 | |
Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
OHSS | 06/07/2015 | 06/12/2015 | | Related | Moderate |
Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
Event Description:Moderate OHSS occurs canceled embryo transfer, OHSS improvement |
Subject received concomitant medications: |
Does the subject have any relevant past or present medical conditions:Yes |
Condition | Start Date | Related to study condition | Ongoing |
HSG: bilateral tubal obstruction | Uk-Unk-2007 | Not on treatment/medication | |
Laparoscopic pelvic sticky points, bilateral ovarian drilling | Uk-Unk-2007 | Not on treatment/medication | |
Cervical biopsy showing inflammation | Uk-Unk-2015 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
Start Date:2016-08-19 End Date:2016-08-20 |
Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C04 |
Subject No :C04-0087 | Subject Initials :HZD | DOB :08/04/1983 | Sex:Female | Race:Asian | Height:161cm | Weight:60kg |
First administration date of batch : | Batch number : |
Study Drug | Start Date | Dose | Change in Dose |
Gonal-f New Pen Stimulation Treatment | 06/26/2015 | 225 | |
Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
OHSS | 07/07/2015 | 07/21/2015 | | Related | Mild |
Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
None(Othervalue:) | Dose reduced | None | Resolved | | |
Event Description:none |
Subject received concomitant medications: |
Does the subject have any relevant past or present medical conditions:Yes |
Condition | Start Date | Related to study condition | Ongoing |
spontaneous abortion | 01/05/2010 | Not on treatment/medication | |
spontaneous abortion | 05/18/2012 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
Start Date:2016-08-19 End Date:2016-08-20 |
Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C04 |
Subject No :C04-0171 | Subject Initials :SHL | DOB :08/17/1987 | Sex:Female | Race:Asian | Height:154cm | Weight:40kg |
First administration date of batch : | Batch number : |
Study Drug | Start Date | Dose | Change in Dose |
Gonal-f New Pen Stimulation Treatment | 09/29/2015 | 300 | |
Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
OHSS | 09/30/2015 | 10/09/2015 | | Related | Mild |
Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
None(Othervalue:) | Dose reduced | None | Resolved | | |
Event Description:none |
Subject received concomitant medications: |
Does the subject have any relevant past or present medical conditions:No |
Condition | Start Date | Related to study condition | Ongoing |
Non Serious Adverse Drug Reactions Report |
Start Date:2016-08-19 End Date:2016-08-20 |
Study :EMR700623-541 | Investigator :Ying Zhong | Country of Investigator :China | SiteNo:C05 |
Subject No :C05-0001 | Subject Initials :XFZ | DOB :01/21/1988 | Sex:Female | Race:Asian | Height:159cm | Weight:50kg |
First administration date of batch : | Batch number : |
Study Drug | Start Date | Dose | Change in Dose |
Gonal-f New Pen Stimulation Treatment | 08/01/2015 | 225 | |
Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
OHSS | 08/16/2015 | 08/18/2015 | | Related | Severe |
Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
None(Othervalue:) | Not applicable | None | Resolved | | |
Event Description:Hydroxyethyl Starch 130/0.4 and Sodium Chloride Injection 500ml,ivgtt bid calcium gluconate injection 10ml+dextrose injection 500ml ivgtt qd |
Subject received concomitant medications: |
Does the subject have any relevant past or present medical conditions:Yes |
Condition | Start Date | Related to study condition | Ongoing |
oophorocystectomy | UK-Jul-2013 | Not on treatment/medication | |
salpingoplasty | UK-Feb-2014 | Not on treatment/medication | |
salpingitis after previous tubal occlusion | UK-Feb-2014 | Not on treatment/medication | Ongoing |
Non Serious Adverse Drug Reactions Report |
Start Date:2016-08-19 End Date:2016-08-20 |
Study :EMR700623-541 | Investigator :Ying Zhong | Country of Investigator :China | SiteNo:C05 |
Subject No :C05-0010 | Subject Initials :Q-Z | DOB :01/31/1990 | Sex:Female | Race:Asian | Height:159cm | Weight:45kg |
First administration date of batch : | Batch number : |
Study Drug | Start Date | Dose | Change in Dose |
Gonal-f New Pen Stimulation Treatment | 08/02/2015 | 225 | |
Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
OHSS | 08/17/2015 | 08/24/2015 | | Related | Moderate |
Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
Disease under study**,Protocol procedure**,Concomitant medication**(Othervalue:) | Dose not changed | Led to study termination | Resolved | | |
Event Description:abdominal distention;nausea Drug:Hydroxyethyl Starch 130/0.4 and Sodium Chloride Injection 500ml,ivgtt bid calcium gluconate injection 10ml+dextrose injection 500ml ivgtt qd 17-Aug-2015 / 27-Aug-2015 |
Subject received concomitant medications: |
Does the subject have any relevant past or present medical conditions:No |
Condition | Start Date | Related to study condition | Ongoing |
Non Serious Adverse Drug Reactions Report |
Start Date:2016-08-19 End Date:2016-08-20 |
Study :EMR700623-541 | Investigator :Ying Zhong | Country of Investigator :China | SiteNo:C05 |
Subject No :C05-0013 | Subject Initials :L-L | DOB :06/12/1986 | Sex:Female | Race:Asian | Height:159cm | Weight:54.5kg |
First administration date of batch : | Batch number : |
Study Drug | Start Date | Dose | Change in Dose |
Gonal-f New Pen Stimulation Treatment | 08/02/2015 | 150 | |
Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
OHSS | 08/18/2015 | 08/20/2015 | | Related | Moderate |
Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
Disease under study**,Protocol procedure**,Concomitant medication**(Othervalue:) | Dose not changed | Led to study termination | Resolved | | |
Event Description:abdominal distention;nausea ,ascites,Drug:Hydroxyethyl Starch 130/0.4 and Sodium Chloride Injection 500ml,ivgtt bid calcium gluconate injection 10ml+dextrose injection 500ml ivgtt qd 18-Aug-2015 / 20-Aug-2015 |
Subject received concomitant medications: |
Does the subject have any relevant past or present medical conditions:Yes |
Condition | Start Date | Related to study condition | Ongoing |
ampullary pregnancy | UK-Unk-2010 | Not on treatment/medication | |
ampullary pregnancy | UK-Unk-2012 | Not on treatment/medication | |
ampullary pregnancy | UK-Unk-2013 | Not on treatment/medication | |
salpingocatheterism | UK-Unk-2013 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
Start Date:2016-08-19 End Date:2016-08-20 |
Study :EMR700623-541 | Investigator :Ying Zhong | Country of Investigator :China | SiteNo:C05 |
Subject No :C05-0021 | Subject Initials :FYZ | DOB :08/28/1990 | Sex:Female | Race:Asian | Height:150cm | Weight:45kg |
First administration date of batch : | Batch number : |
Study Drug | Start Date | Dose | Change in Dose |
Gonal-f New Pen Stimulation Treatment | 08/04/2015 | 225 | |
Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
OHSS | 08/19/2015 | 08/21/2015 | | Related | Mild |
Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
Protocol procedure**,Concomitant medication**(Othervalue:) | Not applicable | None | Resolved | | |
Event Description:abdominal distention;Drug:Hydroxyethyl Starch 130/0.4 and Sodium Chloride Injection 500ml,ivgtt bid calcium gluconate injection 10ml+dextrose injection 500ml ivgtt qd 19-Aug-2015 / 21-Aug-2015 |
Subject received concomitant medications: |
Does the subject have any relevant past or present medical conditions:Yes |
Condition | Start Date | Related to study condition | Ongoing |
salpingocatheterism | UK-Unk-2012 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
Start Date:2016-08-19 End Date:2016-08-20 |
Study :EMR700623-541 | Investigator :Ying Zhong | Country of Investigator :China | SiteNo:C05 |
Subject No :C05-0041 | Subject Initials :W-Y | DOB :07/03/1981 | Sex:Female | Race:Asian | Height:153cm | Weight:55kg |
First administration date of batch : | Batch number : |
Study Drug | Start Date | Dose | Change in Dose |
Gonal-f New Pen Stimulation Treatment | 08/08/2015 | 150 | |
Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
OHSS | 08/23/2015 | 08/25/2015 | | Related | Mild |
Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
Protocol procedure**,Concomitant medication**(Othervalue:) | Dose not changed | Led to study termination | Resolved | | |
Event Description:abdominal distention;Drug:Hydroxyethyl Starch 130/0.4 and Sodium Chloride Injection 500ml,ivgtt bid calcium gluconate injection 10ml+dextrose injection 500ml ivgtt qd 21-Aug-2015 / 25-Aug-2015 |
Subject received concomitant medications: |
Does the subject have any relevant past or present medical conditions:No |
Condition | Start Date | Related to study condition | Ongoing |
Non Serious Adverse Drug Reactions Report |
Start Date:2016-08-19 End Date:2016-08-20 |
Study :EMR700623-541 | Investigator :Ying Zhong | Country of Investigator :China | SiteNo:C05 |
Subject No :C05-0056 | Subject Initials :X-P | DOB :06/14/1983 | Sex:Female | Race:Asian | Height:158cm | Weight:46kg |
First administration date of batch : | Batch number : |
Study Drug | Start Date | Dose | Change in Dose |
Gonal-f New Pen Stimulation Treatment | 08/13/2015 | 150 | |
Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
OHSS | 08/27/2015 | 08/29/2015 | | Related | Mild |
Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
Protocol procedure**,Concomitant medication**(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
Event Description:abdominal distention;nausea ;ascites;Drug:Hydroxyethyl Starch 130/0.4 and Sodium Chloride Injection 500ml,ivgtt bid calcium gluconate injection 10ml+dextrose injection 500ml ivgtt qd 17-Aug-2015 / 27-Aug-2015 |
Subject received concomitant medications: |
Does the subject have any relevant past or present medical conditions:No |
Condition | Start Date | Related to study condition | Ongoing |
Non Serious Adverse Drug Reactions Report |
Start Date:2016-08-19 End Date:2016-08-20 |
Study :EMR700623-541 | Investigator :Ying Zhong | Country of Investigator :China | SiteNo:C05 |
Subject No :C05-0068 | Subject Initials :YPL | DOB :12/07/1985 | Sex:Female | Race:Asian | Height:160cm | Weight:50kg |
First administration date of batch : | Batch number : |
Study Drug | Start Date | Dose | Change in Dose |
Gonal-f New Pen Stimulation Treatment | 08/15/2015 | 225 | |
Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
OHSS | 08/27/2015 | 08/29/2015 | | Related | Moderate |
Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
Protocol procedure**,Concomitant medication**(Othervalue:) | Dose not changed | Led to study termination | Resolved | | |
Event Description:abdominal distention;nausea ;ascites;Drug:Hydroxyethyl Starch 130/0.4 and Sodium Chloride Injection 500ml,ivgtt bid calcium gluconate injection 10ml+dextrose injection 500ml ivgtt qd 17-Aug-2015 / 27-Aug-2015 |
Subject received concomitant medications: |
Does the subject have any relevant past or present medical conditions:Yes |
Condition | Start Date | Related to study condition | Ongoing |
Fallopian tube repair anaplasty | UK-Unk-2010 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
Start Date:2016-08-19 End Date:2016-08-20 |
Study :EMR700623-541 | Investigator :Ying Zhong | Country of Investigator :China | SiteNo:C05 |
Subject No :C05-0117 | Subject Initials :Y-L | DOB :04/16/1982 | Sex:Female | Race:Asian | Height:165cm | Weight:48kg |
First administration date of batch : | Batch number : |
Study Drug | Start Date | Dose | Change in Dose |
Gonal-f New Pen Stimulation Treatment | 08/23/2015 | 225 | |
Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
OHSS | 09/08/2015 | 09/10/2015 | | Related | Mild |
Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
Protocol procedure**,Concomitant medication**(Othervalue:) | Dose reduced | Led to study termination | Resolved | | |
Event Description:abdominal distention;ascites;Drug:Hydroxyethyl Starch 130/0.4 and Sodium Chloride Injection 500ml,ivgtt bid calcium gluconate injection 10ml+dextrose injection 500ml ivgtt qd 19-Aug-2015 / 21-Aug-2015 |
Subject received concomitant medications: |
Does the subject have any relevant past or present medical conditions:No |
Condition | Start Date | Related to study condition | Ongoing |
Non Serious Adverse Drug Reactions Report |
Start Date:2016-08-19 End Date:2016-08-20 |
Study :EMR700623-541 | Investigator :Ying Zhong | Country of Investigator :China | SiteNo:C05 |
Subject No :C05-0141 | Subject Initials :XHZ | DOB :04/14/1987 | Sex:Female | Race:Asian | Height:158cm | Weight:48kg |
First administration date of batch : | Batch number : |
Study Drug | Start Date | Dose | Change in Dose |
Gonal-f New Pen Stimulation Treatment | 08/29/2015 | 150 | |
Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
OHSS | 09/12/2015 | 09/14/2015 | | Related | Moderate |
Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
Protocol procedure**,Concomitant medication**(Othervalue:) | Dose not changed | Led to study termination | Resolved | | |
Event Description:abdominal distention;nausea ;ascites;Drug:Hydroxyethyl Starch 130/0.4 and Sodium Chloride Injection 500ml,ivgtt bid calcium gluconate injection 10ml+dextrose injection 500ml ivgtt qd 17-Aug-2015 / 27-Aug-2015 |
Subject received concomitant medications: |
Does the subject have any relevant past or present medical conditions:Yes |
Condition | Start Date | Related to study condition | Ongoing |
Fallopian tube repair anaplasty | UK-Unk-2009 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
Start Date:2016-08-19 End Date:2016-08-20 |
Study :EMR700623-541 | Investigator :NA | Country of Investigator :Korea | SiteNo:K01 |
Subject No :k01-0059 | Subject Initials :LKH | DOB :08/05/1981 | Sex:Female | Race:Asian | Height:153cm | Weight:74g |
First administration date of batch : | Batch number : |
Study Drug | Start Date | Dose | Change in Dose |
Gonal-f New Pen Stimulation Treatment | 06/02/2015 | 225 | |
Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
OHSS | 06/13/2015 | 07/02/2015 | | Related | Mild |
Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
None(Othervalue:) | Dose not changed | None | Resolved | | |
Event Description: |
Subject received concomitant medications: |
Does the subject have any relevant past or present medical conditions:No |
Condition | Start Date | Related to study condition | Ongoing |
Non Serious Adverse Drug Reactions Report |
Start Date:2016-08-19 End Date:2016-08-20 |
Study :EMR700623-541 | Investigator :NA | Country of Investigator :Korea | SiteNo:K01 |
Subject No :k01-035 | Subject Initials :PSS | DOB :01/19/1983 | Sex:Female | Race:Asian | Height:161cm | Weight:56g |
First administration date of batch : | Batch number : |
Study Drug | Start Date | Dose | Change in Dose |
Gonal-f New Pen Stimulation Treatment | 03/11/2015 | 225 | |
Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
OHSS | 03/23/2015 | 04/21/2015 | | Related | Mild |
Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
None(Othervalue:) | Dose not changed | None | Resolved | | |
Event Description: no addtional data |
Subject received concomitant medications: |
Does the subject have any relevant past or present medical conditions:No |
Condition | Start Date | Related to study condition | Ongoing |
Non Serious Adverse Drug Reactions Report |
Start Date:2016-08-19 End Date:2016-08-20 |
Study :EMR700623-541 | Investigator :NA | Country of Investigator :Korea | SiteNo:K01 |
Subject No :k01-036 | Subject Initials :JSY | DOB :07/28/1981 | Sex:Female | Race:Asian | Height:162cm | Weight:54g |
First administration date of batch : | Batch number : |
Study Drug | Start Date | Dose | Change in Dose |
Gonal-f New Pen Stimulation Treatment | 03/13/2015 | 225 | |
Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
OHSS | 03/24/2015 | 04/07/2015 | | Related | Moderate |
Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
None(Othervalue:) | Dose not changed | Concomitant medication ** | Resolved | | |
Event Description: |
Subject received concomitant medications: |
Does the subject have any relevant past or present medical conditions:No |
Condition | Start Date | Related to study condition | Ongoing |
Non Serious Adverse Drug Reactions Report |
Start Date:2016-08-19 End Date:2016-08-20 |
Study :EMR700623-541 | Investigator :NA | Country of Investigator :Korea | SiteNo:K01 |
Subject No :k01-040 | Subject Initials :LBH | DOB :03/05/1985 | Sex:Female | Race:Asian | Height:164cm | Weight:61g |
First administration date of batch : | Batch number : |
Study Drug | Start Date | Dose | Change in Dose |
Gonal-f New Pen Stimulation Treatment | 04/06/2015 | 225 | |
Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
OHSS | 04/15/2015 | 04/30/2015 | | Related | Mild |
Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
None(Othervalue:) | Dose not changed | None | Resolved | | |
Event Description: |
Subject received concomitant medications: |
Does the subject have any relevant past or present medical conditions:No |
Condition | Start Date | Related to study condition | Ongoing |
Non Serious Adverse Drug Reactions Report |
Start Date:2016-08-19 End Date:2016-08-20 |
Study :EMR700623-541 | Investigator :NA | Country of Investigator :Korea | SiteNo:K01 |
Subject No :k01-049 | Subject Initials :PGR | DOB :02/20/1983 | Sex:Female | Race:Asian | Height:168cm | Weight:62g |
First administration date of batch : | Batch number : |
Study Drug | Start Date | Dose | Change in Dose |
Gonal-f New Pen Stimulation Treatment | 05/02/2015 | 300 | |
Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
OHSS | 05/13/2015 | 05/29/2015 | | Related | Mild |
Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
None(Othervalue:) | Not applicable | Concomitant medication ** | Resolved | | |
Event Description:albumin treatment and resloved |
Subject received concomitant medications: |
Does the subject have any relevant past or present medical conditions:Yes |
Condition | Start Date | Related to study condition | Ongoing |
laparoscopic ovary cystectomy | UK-UNK-2004 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
Start Date:2016-08-19 End Date:2016-08-20 |
Study :EMR700623-541 | Investigator :NA | Country of Investigator :Korea | SiteNo:K01 |
Subject No :k01-050 | Subject Initials :KHG | DOB :04/22/1984 | Sex:Female | Race:Asian | Height:150cm | Weight:46g |
First administration date of batch : | Batch number : |
Study Drug | Start Date | Dose | Change in Dose |
Gonal-f New Pen Stimulation Treatment | 05/03/2015 | 300 | |
Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
OHSS | 05/14/2015 | 05/29/2015 | | Related | Mild |
Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
None(Othervalue:) | Dose not changed | Led to study termination | Resolved | | |
Event Description: |
Subject received concomitant medications: |
Does the subject have any relevant past or present medical conditions:Yes |
Condition | Start Date | Related to study condition | Ongoing |
ovary cystectomy | UK-Jan-2014 | Not on treatment/medication | |